Pancreatic CancerPhase 1/2NCT00769483
MK-0646 and Gemcitabine +/- Erlotinib for Patients With Advanced Pancreatic Cancer
A Phase 1/2 study testing MK-0646, Gemcitabine and Erlotinib in people with Pancreatic Cancer and Pancreatic Adenocarcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Objectives: Primary Objectives: Phase I: Determine the maximal tolerated dose (MTD) of MK-0646 in combination with gemcitabine or gemcitabine plus erlotinib and recommended phase II dose. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Pancreatic Adenocarcinoma
- What is being tested?
- MK-0646, Gemcitabine and Erlotinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2008to 1 Sep 2020
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma, AJCC stage IV
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as =/>20 mm with conventional techniques or as =/>10 mm with spiral CT scan. See Section 11 for the evaluation of measurable disease. Measurable disease must be present outside a previous radiation field or if inside, it must be a new lesion.
- At least 6 months must have elapsed after completion of adjuvant therapy (if applicable).
- Age =/>18 years.
- ECOG Performance Status 0-1 (Karnofsky =/>60%).
- Patients must have adequate organ and marrow function as defined below: 1) leukocytes =/>3,000 cells/mm^3; 2) absolute neutrophil count =/>1,500 cells/mm^3; 4) platelets =/>100,000 cells/mm^3; 5) total bilirubin <1.5mg/dl; 6) AST(SGOT)/ALT(SGPT) =/<2.5 X institutional upper limit of normal for patients without liver metastasis, =/< 5X institutional upper limit of normal for patients with liver metastasis; 7) creatinine - within normal institutional limits OR creatinine clearance =/>60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
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- Fasting blood glucose =/<160 mg/dl, prior to study enrollment. (For higher values, blood glucose may be controlled by dietary intervention, oral hypoglycemics and/ or insulin prior to enrollment).
- Women of child-bearing potential (defined as not post-menopausal for 12 months or no previous surgical sterilization) and fertile men must agree to use adequate contraception for the duration of study participation. Acceptable contraception is defined as double-barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap). Acceptable contraception must be used for 90 days after last dose of study drugs.
- (Continuation of inclusion criteria # 8) Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Ability to understand and the willingness to sign a written informed consent document. Signed informed consent form must be obtained prior to initiation of study evaluations and/or activities.
- INR <1.5 (or =/<3 if on anticoagulation therapy)
- Both men and women and members of all races and ethnic groups are eligible for this trial.
- In phase II expansion cohort, which is primarily for predictive biomarker correlation, patients enrolled will be those with pre-existing core biopsies of primary tumor or metastatic site or must be willing to undergo a biopsy for correlative studies.
Who cannot join
- Prior systemic chemotherapy or biological therapy for metastatic disease
- Prior exposure to IGF-1R inhibitors.
- Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the agents used in the study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant or nursing women are excluded from this study because there is an unknown but potential risk for adverse events in infants secondary to treatment of the mother the study agents. If a pregnancy test (serum or urine) is positive, patient will be excluded.
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- Patients who are known to be HIV-positive are ineligible because these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy.
- No other prior malignancy is allowed except for the following: adequately treated basal or squamous cell skin cancer, in situ cervical cancer, or any other cancer from which the patient has been disease-free for two years.
- Patients must not be currently enrolled in a therapeutic study for pancreatic cancer.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Phase I/ Randomized Phase II Study of Gemcitabine Plus Erlotinib Plus MK-0646; Gemcitabine Plus MK-0646 and Gemcitabine Plus Erlotinib for Patients With Advanced Pancreatic Cancer (IISP#33337)
Objectives:
Primary Objectives:
Read more
- Phase I: Determine the maximal tolerated dose (MTD) of MK-0646 in combination with gemcitabine or gemcitabine plus erlotinib and recommended phase II dose.
- Phase II:
- Assess progression-free survival (PFS) with a) gemcitabine plus MK-0646 b) gemcitabine plus erlotinib plus MK-0646 and c) gemcitabine plus erlotinib.
- Explore IGF1 tissue level as a predictive biomarker for MK-0646 therapy in phase II expansion cohort.
Secondary Objectives:
- Assess overall response rate (ORR), treatment toxicity, and overall survival (OS) with the addition of MK-0646 to gemcitabine or gemcitabine plus erlotinib.
- Correlate PFS and OS with IGF-1, IGFBP-3 levels and the expression of p-IRS, IGF-1R, EMT biomarkers, Akt, Erk, mTOR, and PI13k in tumor cells.
- To assess the incidence of single nucleotide polymorphisms of the IgF1R pathway related genes (IGF1, IGF1R, IRS1 and IRS2). These genotypes will be correlated with the clinical endpoints of this study, including OS, ORR and PFS.
Read the detailed description
Phase I
The Study Drugs:
MK-0646 is designed to block proteins that are thought to cause cancer cells to grow and spread. This drug may help slow the growth of tumors.
Gemcitabine is designed to disrupt the growth of cancer cells, which may cause cancer cells to die.
Erlotinib hydrochloride is designed to block the activity of a protein found on the surface of many tumor cells that may control the growth and survival of cancer cells. This may stop cancer cells from growing.
Study Drug Dose Level and Groups:
If you are found to be eligible to take part in this study, you will be assigned to a group (Arm A or Arm B) based on when you joined the study, how many participants have been enrolled before you, and on the safety data that is available at that time.
- If you are in Arm A, you will receive MK-0646 and gemcitabine.
- If you are in Arm B, you will receive MK-0646, gemcitabine, and erlotinib hydrochloride.
There are 2 dose levels of MK-0646 in each arm. There will be 3-6 participants enrolled in each dose level in each arm. Enrollment will begin in Arm A. Arm B will use the same 2 dose levels as Arm A. If the first dose level of Arm A is found to be tolerable, at least 3 patients will be enrolled in Arm B, Level 1, and then at least 3 patients will be enrolled in Arm A, Level 2. If Arm B, Level 1 and Arm A, Level 2 can be safely given, the last group of 3-6 patients will be enrolled in Arm B, Level 2. The first group of participants in each arm will receive the lower dose level. The next group in each arm will receive a higher dose than the first group, if no intolerable side effects were seen.
The dose of gemcitabine and/or erlotinib hydrochloride will be the same for every group.
Study Drug Administration:
If you are in Arm A, on Days 1, 8, and 15 of each 28-day study cycle, you will receive gemcitabine through a needle into your vein over about 1 1/2 hours. On Days 1, 8, 15, and 22 of each cycle, you will receive MK-0646 by vein over 1 hour.
If you are in Arm B, you will take erlotinib hydrochloride by mouth once a day (in the morning) every day. You should take it with about 1 cup (8 oz.) of water 1 hour before or 2 hours after eating. On Days 1, 8, and 15 of each cycle, you will receive gemcitabine by vein over about 1 1/2 hours. On Days 1, 8, 15, and 22 of each cycle, you will receive MK-0646 by vein over 1 hour.
Depending upon how well you tolerate gemcitabine, your doctor may decide that you should receive gemcitabine on Days 1 and 15 instead of Days 1, 8, and 15.
Study Visits:
On Day 1 of Cycle 1, the following tests and procedures will be performed:
- Your medical history will be recorded.
- You will have a performance status evaluation.
- You will be asked to list any drugs you may be taking and if you have experienced any side effects.
- You will have a physical exam, including measurement of your vital signs and weight.
- Blood (about 2 teaspoons) will be drawn for routine tests.
- Blood (about 1 teaspoon) will be drawn to make sure your body has not created cells to fight against MK-0646. These cells are called human anti-human antibodies (also known as HAHA).
On Day 8 of Cycle 1, the following tests and procedures will be performed:
- Your vital signs and weight will be measured.
- Blood (about 2 teaspoons) will be drawn for routine tests.
- You will be asked if you have experienced any side effects.
On Day 15 of Cycle 1, the following tests and procedures will be performed:
- You will have a performance status evaluation.
- You will be asked to list any drugs you may be taking and if you have experienced any side effects.
- You will have a physical exam, including measurement of your vital signs and weight.
- Blood (about 2 teaspoons) will be drawn for routine tests.
On Day 22 of Cycle 1, the following tests and procedures will be performed:
- Your vital signs and weight will be measured.
- Blood (about 1 teaspoon) will be drawn to test for HAHA.
- You will be asked if you have experienced any side effects.
- Blood (about 2 teaspoons) will be drawn for routine tests.
On Day 1 of Cycles 2 and beyond, the following tests and procedures will be performed:
- You will have a performance status evaluation.
- You will be asked to list any drugs you may be taking and if you have experienced any side effects.
- You will have a physical exam, including measurement of your vital signs and weight
- Blood (about 2 teaspoons) will be drawn for routine tests.
- Blood (about 1 teaspoon) will be drawn for testing of CA 19-9.
On Days 8 and 15 of Cycles 2 and beyond, the following tests and procedures will be performed:
- Your vital signs and weight will be measured.
- Blood (about 2 teaspoons) will be drawn for routine tests.
- You will be asked if you have experienced any side effects.
On Day 22 of Cycles 2 and beyond, your vital signs and weight will be measured and you will be asked if you have experienced any side effects.
On Day 22 of Cycle 2 and every even cycle (Cycles 4, 6, 8, and so on), you will have a CT scan or MRI scan to check the status of the disease. Blood (about 1 teaspoon) will also be drawn to test HAHA.
Length of Study:
You may remain on study for as long as you are benefiting. You will be taken off study if the disease gets worse or you experience intolerable side effects.
End-of-Study Visit:
After you go off study, you will have an end-of-study visit. At this visit, the following tests and procedures will be performed:
- You will have a performance status evaluation.
- You will be asked to list any drugs you may be taking and if you have experienced any side effects.
- You will have a physical exam, including measurement of your vital signs and weight.
- You will have a CT scan or MRI scan to check the status of the disease.
- Blood (about 2 teaspoons) will be collected for routine tests.
- Blood (about 1 teaspoon) will be drawn to test HAHA.
- Blood (about 1 teaspoon) will be drawn to test CA 19-9.
At Weeks 4, 8, and 12 after the end of study visit, blood (about 1 teaspoon) will be drawn to test HAHA.
Long-Term Follow Up:
Once you are off study, every 3 months from then on, the study staff will ask you how you are doing, either in the clinic or by telephone. If you are called, the phone call will take about 10-15 minutes.
This is an investigational study. MK-0646 is not FDA approved or commercially available. At this time, MK-0646 is only being used in research. Gemcitabine is FDA approved and commercially available for the treatment of pancreatic cancer. Erlotinib hydrochloride is FDA approved and commercially available for the treatment of pancreatic cancer in combination with gemcitabine.
Up to 100 patients will take part in this study. All will be enrolled at MD Anderson.
Phase II:
The Study Drugs:
MK-0646 is designed to block proteins that are thought to cause cancer cells to grow and spread. This drug may help slow the growth of tumors.
Gemcitabine is designed to disrupt the growth of cancer cells, which may cause cancer cells to die.
Erlotinib hydrochloride is designed to block the activity of a protein found on the surface of many tumor cells that may control the growth and survival of cancer cells. This may stop cancer cells from growing.
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the roll of the dice) into 1 of 3 groups.
- If you are in Arm A, you will receive gemcitabine and MK-0646.
- If you are in Arm B, you will receive erlotinib hydrochloride, gemcitabine, and MK-0646.
- If you are in Arm C, you will receive erlotinib hydrochloride and gemcitabine.
Study Drug Administration:
If you are in Arm A, on Days 1, 8, and 15 of each 28-day study cycle, you will receive gemcitabine through a needle into your vein over about 1 1/2 hours as an infusion once a week for 3 weeks. On Days 1, 8, 15, and 22 of each cycle, you will receive MK-0646 by vein over 1 hour.
If you are in Arm B, you will take erlotinib hydrochloride by mouth once (in the morning) every day. On Days 1, 8, and 15 of each cycle, you will receive gemcitabine by vein over about 1 1/2 hours. On Days 1, 8, 15, and 22 of each cycle, you will receive MK-0646 by vein over 1 hour.
If you are in Arm C, you will take erlotinib hydrochloride by mouth once (in the morning) every day. On Days 1, 8, and 15 of each cycle, you will receive gemcitabine by vein over about 1 1/2 hours.
If you are taking erlotinib hydrochloride, you should take it with about 1 cup (8 oz.) of water 1 hour before or 2 hours after eating.
Depending upon how well you tolerate gemcitabine, your doctor may decide that you should receive gemcitabine on Days 1 and 15 instead of Days 1, 8, and 15.
Study Visits:
On Day 1 of Cycle 1, the following tests and procedures will be performed:
- Your medical history will be recorded.
- You will have a performance status evaluation.
- You will be asked to list any drugs you may be taking and if you have experienced any side effects.
- You will have a physical exam, including measurement of your vital signs and weight.
- Blood (about 2 teaspoons) will be drawn for routine tests.
- If you are assigned to receive MK-0646, blood (about 1 teaspoon) will be drawn to make sure your body has not created cells to fight against MK-0646. These cells are called human anti-human antibodies (also known as HAHA).
On Day 8 of Cycle 1, the following tests and procedures will be performed:
- Your vital signs and weight will be measured.
- Blood (about 2 teaspoons) will be drawn for routine tests.
- You will be asked if you have experienced any side effects.
On Day 15 of Cycle 1, the following tests and procedures will be performed:
- You will have a performance status evaluation.
- You will be asked to list any drugs you may be taking and if you have experienced any side effects.
- You will have a physical exam, including measurement of your vital signs and weight.
- Blood (about 2 teaspoons) will be drawn for routine tests.
On Day 22 of Cycle 1, the following tests and procedures will be performed if you are receiving MK-0646:
- Your vital signs and weight will be measured
- Blood (about 1 teaspoon) will be drawn to test for HAHA.
- You will be asked if you have experienced any side effects.
On Day 1 of Cycles 2 and beyond, the following tests and procedures will be performed:
- You will have a performance status evaluation.
- You will be asked about any other drugs you may be taking and if you have experienced any side effects.
- You will have a physical exam, including measurement of your vital signs and weight
- Blood (about 2 teaspoons) will be drawn for routine tests.
- Blood (about 1 teaspoon) will be drawn for testing of CA 19-9.
On Days 8 and 15 of Cycles 2 and beyond, the following tests and procedures will be performed:
- Your vital signs and weight will be measured.
- Blood (about 2 teaspoons) will be drawn for routine tests.
- You will be asked if you have experienced any side effects.
On Day 22 of Cycles 2 and beyond, your vital signs and weight will be measured, (if you are receiving MK-0646). and you will be asked if you have experienced any side effects.
On Day 22 of Cycle 2 and every even cycle (Cycles 4, 6, 8, and so on), you will have a CT scan or MRI scan to check the status of the disease. Blood (about 1 teaspoon) will be also be drawn to test HAHA if you are receiving MK-0646.
Length of Study:
You may remain on study for as long as you are benefiting. You will be taken off study if the disease gets worse or you experience intolerable side effects.
If you are in Arm C (erlotinib and gemcitabine) and the disease gets worse, you may be allowed to join Arm B (gemcitabine, erlotinib, and MK-0646).
End-of-Study Visit:
After you go off study, you will have an end-of-study visit. At this visit the following tests and procedures will be performed:
- You will have a performance status evaluation.
- You will be asked to list any drugs you may be taking and if you have experienced any side effects.
- You will have a physical exam, including measurement of your vital signs and weight.
- You will have a CT scan or MRI scan to check the status of the disease.
- Blood (about 2 teaspoons) will be collected for routine tests.
- Blood (about 1 teaspoon) will be drawn for testing of CA 19-9.
- Blood (about 1 teaspoon) will be drawn for testing to test HAHA if you are receiving MK-0646.
At Weeks 4, 8, and 12 after the end of study visit, blood (about 1 teaspoon) will be drawn to test HAHA if you were receiving MK-0646.
Long-Term Follow Up:
Once you are off study, every 3 months from then on, the study staff will ask you how you are doing, either in the clinic or by telephone. If you are called, this phone call will take about 10-15 minutes.
This is an investigational study. MK-0646 is not FDA approved or commercially available. At this time, MK-0646 is only being used in research. Gemcitabine is FDA approved and commercially available for the treatment of pancreatic cancer. Erlotinib hydrochloride is FDA approved and commercially available for the treatment of pancreatic cancer in combination with gemcitabine.
Up to 100 patients will take part in this study. All will be enrolled at MD Anderson.
Phase II Expansion Cohort:
The Study Drugs:
MK-0646 is designed to block proteins that are thought to cause cancer cells to grow and spread. This drug may help slow the growth of tumors.
Gemcitabine is designed to disrupt the growth of cancer cells, which may cause cancer cells to die.
Study Treatments:
If you are found to be eligible to take part in this study, you will receive gemcitabine and MK-0646.
Study Drug Administration:
On Days 1, 8, and 15 of each 28-day study cycle, you will receive gemcitabine through a needle into your vein over about 1 1/2 hours as an infusion once a week for 3 weeks. On Days 1, 8, 15, and 22 of each cycle, you will receive MK-0646 by vein over 1 hour.
Depending upon how well you tolerate gemcitabine, your doctor may decide that you should receive gemcitabine on Days 1 and 15 instead of Days 1, 8, and 15.
Study Visits:
On Day 1 of Cycle 1, the following tests and procedures will be performed:
- Your medical history will be recorded.
- You will have a performance status evaluation.
- You will be asked to list any drugs you may be taking and if you have experienced any side effects.
- You will have a physical exam, including measurement of your vital signs and weight.
- Blood (about 2 teaspoons) will be drawn for routine tests.
On Day 8 of Cycle 1, the following tests and procedures will be performed:
- Your vital signs and weight will be measured.
- Blood (about 2 teaspoons) will be drawn for routine tests.
- You will be asked if you have experienced any side effects.
On Day 15 of Cycle 1, the following tests and procedures will be performed:
- You will have a performance status evaluation.
- You will be asked to list any drugs you may be taking and if you have experienced any side effects.
- You will have a physical exam, including measurement of your vital signs and weight.
- Blood (about 2 teaspoons) will be drawn for routine tests.
On Day 22 of Cycle 1, the following tests and procedures will be performed if you are receiving MK-0646:
- Your vital signs and weight will be measured
- You will be asked if you have experienced any side effects
- Blood (about 1 tablespoon) will be drawn for biomarker testing.
On Day 1 of Cycles 2 and beyond, the following tests and procedures will be performed:
- You will have a performance status evaluation.
- You will be asked about any other drugs you may be taking and if you have experienced any side effects.
- You will have a physical exam, including measurement of your vital signs and weight
- Blood (about 2 teaspoons) will be drawn for routine tests.
- Blood (about 1 teaspoon) will be drawn for testing of CA 19-9.
On Days 8 and 15 of Cycles 2 and beyond, the following tests and procedures will be performed:
- Your vital signs and weight will be measured.
- Blood (about 2 teaspoons) will be drawn for routine tests.
- You will be asked if you have experienced any side effects.
On Day 22 of Cycles 2 and beyond, your vital signs and weight will be measured and you will be asked if you have experienced any side effects.
On Day 22 of Cycle 2 and every even cycle (Cycles 4, 6, 8, and so on), you will have a CT scan or MRI scan to check the status of the disease.
Length of Study:
You may remain on study for as long as you are benefiting. You will be taken off study if the disease gets worse or you experience intolerable side effects.
End-of-Study Visit:
After you go off study, you will have an end-of-study visit. At this visit the following tests and procedures will be performed:
- You will have a performance status evaluation.
- You will be asked to list any drugs you may be taking and if you have experienced any side effects.
- You will have a physical exam, including measurement of your vital signs and weight.
- You will have a CT scan or MRI scan to check the status of the disease.
- Blood (about 2 teaspoons) will be collected for routine tests.
- Blood (about 1 teaspoon) will be drawn for testing of CA 19-9.
Long-Term Follow Up:
Once you are off study, every 3 months from then on, the study staff will ask you how you are doing, either in the clinic or by telephone. If you are called, this phone call will take about 10-15 minutes.
This is an investigational study. MK-0646 is not FDA approved or commercially available. At this time, MK-0646 is only being used in research. Gemcitabine is FDA approved and commercially available for the treatment of pancreatic cancer.
Up to 100 patients total will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Pancreatic Cancer, Pancreatic Adenocarcinoma
- Being tested
- MK-0646, Gemcitabine, Erlotinib
- Keywords
- Pancreas, Pancreatic Cancer, Advanced cancer of the pancreas, Pancreatic Adenocarcinoma, MK-0646, Gemcitabine, Gemzar, Erlotinib hydrochloride, Erlotinib, OSI-774, Tarceva
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-0646Drug
Starting Dose Level: 5 mg/kg given intravenously over 60 minutes Days 1, 8, 15, 22 of 28 Day Cycle.
GemcitabineDrug
Also called Gemzar, Gemcitabine Hydrochloride
1000 mg/m^2 given intravenously over 1-1/2 hours Days 1, 8, and 15 of each 28 Day Cycle.
ErlotinibDrug
Also called OSI-774, Tarceva, Erlotinib Hydrochloride
100 mg by mouth daily.
| Study group | Role | What they receive |
|---|---|---|
| Phase I, Arm A | Experimental | MK-0646 + Gemcitabine Receives: Drug: MK-0646; Drug: Gemcitabine |
| Phase I, Arm B | Experimental | MK-0646 + Gemcitabine + Erlotinib Receives: Drug: MK-0646; Drug: Gemcitabine; Drug: Erlotinib |
| Phase II, Arm A | Experimental | Gemcitabine + Erlotinib Receives: Drug: MK-0646; Drug: Gemcitabine |
| Phase II, Arm B | Experimental | MK-0646 + Gemcitabine + Erlotinib Receives: Drug: MK-0646; Drug: Gemcitabine; Drug: Erlotinib |
| Phase II, Arm C | Experimental | Gemcitabine + Erlotinib Receives: Drug: Gemcitabine; Drug: Erlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
MK-0646 Maximum Tolerable Dose
MK-0646 10 mg/kg was declared to be the MTD in combination with gemcitabine and 5 mg/kg the MTD in combination with Gemcitabine and erlotinib
Measured: up to 12 cycles
Progression Free Survival
Time interval (in months) from date of randomization until the date of first documented progression or date of death from any cause, whichever came first
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Secondary outcomes (3)
Overall Survival
Time interval (in months) from date of randomization until the date of death from any cause
Measured: From date of randomization until the date of death from any cause, assessed up to 100 months
Overall Response Rate
Complete response + Partial response using RECIST (Response Evaluation Criteria in Solid Tumors)
Measured: From start of the treatment until disease progression/recurrence; or through study completion (average of 1 year)
Treatment Toxicity
Number of patients who developed toxicity from treatment according to the National Cancer Institute's Common Terminology Criteria
Measured: Through the treatment cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2008 (estimated)
- Study start13 Nov 2008
- Primary completion1 Sep 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Milind Javle, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00769483
- Sponsor's protocol ID
- 2007-0910
- Other IDs
- NCI-2010-01049
- Status last verified
- Sep 2020
- First submitted
- 8 Oct 2008
- Last updated
- 3 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Abdel-Wahab R, Varadhachary GR, Bhosale PR, Wang X, Fogelman DR, Shroff RT, Overman MJ, Wolff RA, Javle M. Randomized, phase I/II study of gemcitabine plus IGF-1R antagonist (MK-0646) versus gemcitabine plus erlotinib with and without MK-0646 for advanced pancreatic adenocarcinoma. J Hematol Oncol. 2018 May 30;11(1):71. doi: 10.1186/s13045-018-0616-2.
PubMed 29843755
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/ Randomized Phase II Study of Gemcitabine Plus Erlotinib Plus MK-0646; Gemcitabine Plus MK-0646 and Gemcitabine Plus Erlotinib for Patients With Advanced Pancreatic Cancer (IISP#33337)
- ClinicalTrials.gov ID
- NCT00769483
- Acronym / sponsor ID
- 2007-0910
- Conditions
- Pancreatic Cancer, Pancreatic Adenocarcinoma
- Keywords
- Pancreas, Pancreatic Cancer, Advanced cancer of the pancreas, Pancreatic Adenocarcinoma, MK-0646, Gemcitabine, Gemzar, Erlotinib hydrochloride
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 13 Nov 2008 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 9 Oct 2008 (estimated)
- Results
- Posted 20 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives:
Primary Objectives:
- Phase I: Determine the maximal tolerated dose (MTD) of MK-0646 in combination with gemcitabine or gemcitabine plus erlotinib and recommended phase II dose.
- Phase II:
- Assess progression-free survival (PFS) with a) gemcitabine plus MK-0646 b) gemcitabine plus erlotinib plus MK-0646 and c) gemcitabine plus erlotinib.
- Explore IGF1 tissue level as a predictive biomarker for MK-0646 therapy in phase II expansion cohort.
Secondary Objectives:
- Assess overall response rate (ORR), treatment toxicity, and overall survival (OS) with the addition of MK-0646 to gemcitabine or gemcitabine plus erlotinib.
- Correlate PFS and OS with IGF-1, IGFBP-3 levels and the expression of p-IRS, IGF-1R, EMT biomarkers, Akt, Erk, mTOR, and PI13k in tumor cells.
- To assess the incidence of single nucleotide polymorphisms of the IgF1R pathway related genes (IGF1, IGF1R, IRS1 and IRS2). These genotypes will be correlated with the clinical endpoints of this study, including OS, ORR and PFS.
Detailed description
Phase I
The Study Drugs:
MK-0646 is designed to block proteins that are thought to cause cancer cells to grow and spread. This drug may help slow the growth of tumors.
Gemcitabine is designed to disrupt the growth of cancer cells, which may cause cancer cells to die.
Erlotinib hydrochloride is designed to block the activity of a protein found on the surface of many tumor cells that may control the growth and survival of cancer cells. This may stop cancer cells from growing.
Study Drug Dose Level and Groups:
If you are found to be eligible to take part in this study, you will be assigned to a group (Arm A or Arm B) based on when you joined the study, how many participants have been enrolled before you, and on the safety data that is available at that time.
- If you are in Arm A, you will receive MK-0646 and gemcitabine.
- If you are in Arm B, you will receive MK-0646, gemcitabine, and erlotinib hydrochloride.
There are 2 dose levels of MK-0646 in each arm. There will be 3-6 participants enrolled in each dose level in each arm. Enrollment will begin in Arm A. Arm B will use the same 2 dose levels as Arm A. If the first dose level of Arm A is found to be tolerable, at least 3 patients will be enrolled in Arm B, Level 1, and then at least 3 patients will be enrolled in Arm A, Level 2. If Arm B, Level 1 and Arm A, Level 2 can be safely given, the last group of 3-6 patients will be enrolled in Arm B, Level 2. The first group of participants in each arm will receive the lower dose level. The next group in each arm will receive a higher dose than the first group, if no intolerable side effects were seen.
The dose of gemcitabine and/or erlotinib hydrochloride will be the same for every group.
Study Drug Administration:
If you are in Arm A, on Days 1, 8, and 15 of each 28-day study cycle, you will receive gemcitabine through a needle into your vein over about 1 1/2 hours. On Days 1, 8, 15, and 22 of each cycle, you will receive MK-0646 by vein over 1 hour.
If you are in Arm B, you will take erlotinib hydrochloride by mouth once a day (in the morning) every day. You should take it with about 1 cup (8 oz.) of water 1 hour before or 2 hours after eating. On Days 1, 8, and 15 of each cycle, you will receive gemcitabine by vein over about 1 1/2 hours. On Days 1, 8, 15, and 22 of each cycle, you will receive MK-0646 by vein over 1 hour.
Depending upon how well you tolerate gemcitabine, your doctor may decide that you should receive gemcitabine on Days 1 and 15 instead of Days 1, 8, and 15.
Study Visits:
On Day 1 of Cycle 1, the following tests and procedures will be performed:
- Your medical history will be recorded.
- You will have a performance status evaluation.
- You will be asked to list any drugs you may be taking and if you have experienced any side effects.
- You will have a physical exam, including measurement of your vital signs and weight.
- Blood (about 2 teaspoons) will be drawn for routine tests.
- Blood (about 1 teaspoon) will be drawn to make sure your body has not created cells to fight against MK-0646. These cells are called human anti-human antibodies (also known as HAHA).
On Day 8 of Cycle 1, the following tests and procedures will be performed:
- Your vital signs and weight will be measured.
- Blood (about 2 teaspoons) will be drawn for routine tests.
- You will be asked if you have experienced any side effects.
On Day 15 of Cycle 1, the following tests and procedures will be performed:
- You will have a performance status evaluation.
- You will be asked to list any drugs you may be taking and if you have experienced any side effects.
- You will have a physical exam, including measurement of your vital signs and weight.
- Blood (about 2 teaspoons) will be drawn for routine tests.
On Day 22 of Cycle 1, the following tests and procedures will be performed:
- Your vital signs and weight will be measured.
- Blood (about 1 teaspoon) will be drawn to test for HAHA.
- You will be asked if you have experienced any side effects.
- Blood (about 2 teaspoons) will be drawn for routine tests.
On Day 1 of Cycles 2 and beyond, the following tests and procedures will be performed:
- You will have a performance status evaluation.
- You will be asked to list any drugs you may be taking and if you have experienced any side effects.
- You will have a physical exam, including measurement of your vital signs and weight
- Blood (about 2 teaspoons) will be drawn for routine tests.
- Blood (about 1 teaspoon) will be drawn for testing of CA 19-9.
On Days 8 and 15 of Cycles 2 and beyond, the following tests and procedures will be performed:
- Your vital signs and weight will be measured.
- Blood (about 2 teaspoons) will be drawn for routine tests.
- You will be asked if you have experienced any side effects.
On Day 22 of Cycles 2 and beyond, your vital signs and weight will be measured and you will be asked if you have experienced any side effects.
On Day 22 of Cycle 2 and every even cycle (Cycles 4, 6, 8, and so on), you will have a CT scan or MRI scan to check the status of the disease. Blood (about 1 teaspoon) will also be drawn to test HAHA.
Length of Study:
You may remain on study for as long as you are benefiting. You will be taken off study if the disease gets worse or you experience intolerable side effects.
End-of-Study Visit:
After you go off study, you will have an end-of-study visit. At this visit, the following tests and procedures will be performed:
- You will have a performance status evaluation.
- You will be asked to list any drugs you may be taking and if you have experienced any side effects.
- You will have a physical exam, including measurement of your vital signs and weight.
- You will have a CT scan or MRI scan to check the status of the disease.
- Blood (about 2 teaspoons) will be collected for routine tests.
- Blood (about 1 teaspoon) will be drawn to test HAHA.
- Blood (about 1 teaspoon) will be drawn to test CA 19-9.
At Weeks 4, 8, and 12 after the end of study visit, blood (about 1 teaspoon) will be drawn to test HAHA.
Long-Term Follow Up:
Once you are off study, every 3 months from then on, the study staff will ask you how you are doing, either in the clinic or by telephone. If you are called, the phone call will take about 10-15 minutes.
This is an investigational study. MK-0646 is not FDA approved or commercially available. At this time, MK-0646 is only being used in research. Gemcitabine is FDA approved and commercially available for the treatment of pancreatic cancer. Erlotinib hydrochloride is FDA approved and commercially available for the treatment of pancreatic cancer in combination with gemcitabine.
Up to 100 patients will take part in this study. All will be enrolled at MD Anderson.
Phase II:
The Study Drugs:
MK-0646 is designed to block proteins that are thought to cause cancer cells to grow and spread. This drug may help slow the growth of tumors.
Gemcitabine is designed to disrupt the growth of cancer cells, which may cause cancer cells to die.
Erlotinib hydrochloride is designed to block the activity of a protein found on the surface of many tumor cells that may control the growth and survival of cancer cells. This may stop cancer cells from growing.
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the roll of the dice) into 1 of 3 groups.
- If you are in Arm A, you will receive gemcitabine and MK-0646.
- If you are in Arm B, you will receive erlotinib hydrochloride, gemcitabine, and MK-0646.
- If you are in Arm C, you will receive erlotinib hydrochloride and gemcitabine.
Study Drug Administration:
If you are in Arm A, on Days 1, 8, and 15 of each 28-day study cycle, you will receive gemcitabine through a needle into your vein over about 1 1/2 hours as an infusion once a week for 3 weeks. On Days 1, 8, 15, and 22 of each cycle, you will receive MK-0646 by vein over 1 hour.
If you are in Arm B, you will take erlotinib hydrochloride by mouth once (in the morning) every day. On Days 1, 8, and 15 of each cycle, you will receive gemcitabine by vein over about 1 1/2 hours. On Days 1, 8, 15, and 22 of each cycle, you will receive MK-0646 by vein over 1 hour.
If you are in Arm C, you will take erlotinib hydrochloride by mouth once (in the morning) every day. On Days 1, 8, and 15 of each cycle, you will receive gemcitabine by vein over about 1 1/2 hours.
If you are taking erlotinib hydrochloride, you should take it with about 1 cup (8 oz.) of water 1 hour before or 2 hours after eating.
Depending upon how well you tolerate gemcitabine, your doctor may decide that you should receive gemcitabine on Days 1 and 15 instead of Days 1, 8, and 15.
Study Visits:
On Day 1 of Cycle 1, the following tests and procedures will be performed:
- Your medical history will be recorded.
- You will have a performance status evaluation.
- You will be asked to list any drugs you may be taking and if you have experienced any side effects.
- You will have a physical exam, including measurement of your vital signs and weight.
- Blood (about 2 teaspoons) will be drawn for routine tests.
- If you are assigned to receive MK-0646, blood (about 1 teaspoon) will be drawn to make sure your body has not created cells to fight against MK-0646. These cells are called human anti-human antibodies (also known as HAHA).
On Day 8 of Cycle 1, the following tests and procedures will be performed:
- Your vital signs and weight will be measured.
- Blood (about 2 teaspoons) will be drawn for routine tests.
- You will be asked if you have experienced any side effects.
On Day 15 of Cycle 1, the following tests and procedures will be performed:
- You will have a performance status evaluation.
- You will be asked to list any drugs you may be taking and if you have experienced any side effects.
- You will have a physical exam, including measurement of your vital signs and weight.
- Blood (about 2 teaspoons) will be drawn for routine tests.
On Day 22 of Cycle 1, the following tests and procedures will be performed if you are receiving MK-0646:
- Your vital signs and weight will be measured
- Blood (about 1 teaspoon) will be drawn to test for HAHA.
- You will be asked if you have experienced any side effects.
On Day 1 of Cycles 2 and beyond, the following tests and procedures will be performed:
- You will have a performance status evaluation.
- You will be asked about any other drugs you may be taking and if you have experienced any side effects.
- You will have a physical exam, including measurement of your vital signs and weight
- Blood (about 2 teaspoons) will be drawn for routine tests.
- Blood (about 1 teaspoon) will be drawn for testing of CA 19-9.
On Days 8 and 15 of Cycles 2 and beyond, the following tests and procedures will be performed:
- Your vital signs and weight will be measured.
- Blood (about 2 teaspoons) will be drawn for routine tests.
- You will be asked if you have experienced any side effects.
On Day 22 of Cycles 2 and beyond, your vital signs and weight will be measured, (if you are receiving MK-0646). and you will be asked if you have experienced any side effects.
On Day 22 of Cycle 2 and every even cycle (Cycles 4, 6, 8, and so on), you will have a CT scan or MRI scan to check the status of the disease. Blood (about 1 teaspoon) will be also be drawn to test HAHA if you are receiving MK-0646.
Length of Study:
You may remain on study for as long as you are benefiting. You will be taken off study if the disease gets worse or you experience intolerable side effects.
If you are in Arm C (erlotinib and gemcitabine) and the disease gets worse, you may be allowed to join Arm B (gemcitabine, erlotinib, and MK-0646).
End-of-Study Visit:
After you go off study, you will have an end-of-study visit. At this visit the following tests and procedures will be performed:
- You will have a performance status evaluation.
- You will be asked to list any drugs you may be taking and if you have experienced any side effects.
- You will have a physical exam, including measurement of your vital signs and weight.
- You will have a CT scan or MRI scan to check the status of the disease.
- Blood (about 2 teaspoons) will be collected for routine tests.
- Blood (about 1 teaspoon) will be drawn for testing of CA 19-9.
- Blood (about 1 teaspoon) will be drawn for testing to test HAHA if you are receiving MK-0646.
At Weeks 4, 8, and 12 after the end of study visit, blood (about 1 teaspoon) will be drawn to test HAHA if you were receiving MK-0646.
Long-Term Follow Up:
Once you are off study, every 3 months from then on, the study staff will ask you how you are doing, either in the clinic or by telephone. If you are called, this phone call will take about 10-15 minutes.
This is an investigational study. MK-0646 is not FDA approved or commercially available. At this time, MK-0646 is only being used in research. Gemcitabine is FDA approved and commercially available for the treatment of pancreatic cancer. Erlotinib hydrochloride is FDA approved and commercially available for the treatment of pancreatic cancer in combination with gemcitabine.
Up to 100 patients will take part in this study. All will be enrolled at MD Anderson.
Phase II Expansion Cohort:
The Study Drugs:
MK-0646 is designed to block proteins that are thought to cause cancer cells to grow and spread. This drug may help slow the growth of tumors.
Gemcitabine is designed to disrupt the growth of cancer cells, which may cause cancer cells to die.
Study Treatments:
If you are found to be eligible to take part in this study, you will receive gemcitabine and MK-0646.
Study Drug Administration:
On Days 1, 8, and 15 of each 28-day study cycle, you will receive gemcitabine through a needle into your vein over about 1 1/2 hours as an infusion once a week for 3 weeks. On Days 1, 8, 15, and 22 of each cycle, you will receive MK-0646 by vein over 1 hour.
Depending upon how well you tolerate gemcitabine, your doctor may decide that you should receive gemcitabine on Days 1 and 15 instead of Days 1, 8, and 15.
Study Visits:
On Day 1 of Cycle 1, the following tests and procedures will be performed:
- Your medical history will be recorded.
- You will have a performance status evaluation.
- You will be asked to list any drugs you may be taking and if you have experienced any side effects.
- You will have a physical exam, including measurement of your vital signs and weight.
- Blood (about 2 teaspoons) will be drawn for routine tests.
On Day 8 of Cycle 1, the following tests and procedures will be performed:
- Your vital signs and weight will be measured.
- Blood (about 2 teaspoons) will be drawn for routine tests.
- You will be asked if you have experienced any side effects.
On Day 15 of Cycle 1, the following tests and procedures will be performed:
- You will have a performance status evaluation.
- You will be asked to list any drugs you may be taking and if you have experienced any side effects.
- You will have a physical exam, including measurement of your vital signs and weight.
- Blood (about 2 teaspoons) will be drawn for routine tests.
On Day 22 of Cycle 1, the following tests and procedures will be performed if you are receiving MK-0646:
- Your vital signs and weight will be measured
- You will be asked if you have experienced any side effects
- Blood (about 1 tablespoon) will be drawn for biomarker testing.
On Day 1 of Cycles 2 and beyond, the following tests and procedures will be performed:
- You will have a performance status evaluation.
- You will be asked about any other drugs you may be taking and if you have experienced any side effects.
- You will have a physical exam, including measurement of your vital signs and weight
- Blood (about 2 teaspoons) will be drawn for routine tests.
- Blood (about 1 teaspoon) will be drawn for testing of CA 19-9.
On Days 8 and 15 of Cycles 2 and beyond, the following tests and procedures will be performed:
- Your vital signs and weight will be measured.
- Blood (about 2 teaspoons) will be drawn for routine tests.
- You will be asked if you have experienced any side effects.
On Day 22 of Cycles 2 and beyond, your vital signs and weight will be measured and you will be asked if you have experienced any side effects.
On Day 22 of Cycle 2 and every even cycle (Cycles 4, 6, 8, and so on), you will have a CT scan or MRI scan to check the status of the disease.
Length of Study:
You may remain on study for as long as you are benefiting. You will be taken off study if the disease gets worse or you experience intolerable side effects.
End-of-Study Visit:
After you go off study, you will have an end-of-study visit. At this visit the following tests and procedures will be performed:
- You will have a performance status evaluation.
- You will be asked to list any drugs you may be taking and if you have experienced any side effects.
- You will have a physical exam, including measurement of your vital signs and weight.
- You will have a CT scan or MRI scan to check the status of the disease.
- Blood (about 2 teaspoons) will be collected for routine tests.
- Blood (about 1 teaspoon) will be drawn for testing of CA 19-9.
Long-Term Follow Up:
Once you are off study, every 3 months from then on, the study staff will ask you how you are doing, either in the clinic or by telephone. If you are called, this phone call will take about 10-15 minutes.
This is an investigational study. MK-0646 is not FDA approved or commercially available. At this time, MK-0646 is only being used in research. Gemcitabine is FDA approved and commercially available for the treatment of pancreatic cancer.
Up to 100 patients total will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Phase I, Arm A | Experimental | Drug: MK-0646, Drug: GemcitabineMK-0646 + Gemcitabine |
| Phase I, Arm B | Experimental | Drug: MK-0646, Drug: Gemcitabine, Drug: ErlotinibMK-0646 + Gemcitabine + Erlotinib |
| Phase II, Arm A | Experimental | Drug: MK-0646, Drug: GemcitabineGemcitabine + Erlotinib |
| Phase II, Arm B | Experimental | Drug: MK-0646, Drug: Gemcitabine, Drug: ErlotinibMK-0646 + Gemcitabine + Erlotinib |
| Phase II, Arm C | Experimental | Drug: Gemcitabine, Drug: ErlotinibGemcitabine + Erlotinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Pathologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma, AJCC stage IV
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as =/>20 mm with conventional techniques or as =/>10 mm with spiral CT scan. See Section 11 for the evaluation of measurable disease. Measurable disease must be present outside a previous radiation field or if inside, it must be a new lesion.
- At least 6 months must have elapsed after completion of adjuvant therapy (if applicable).
- Age =/>18 years.
- ECOG Performance Status 0-1 (Karnofsky =/>60%).
Key exclusion criteria (9 listed)
- Prior systemic chemotherapy or biological therapy for metastatic disease
- Prior exposure to IGF-1R inhibitors.
- Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the agents used in the study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MK-0646Starting Dose Level: 5 mg/kg given intravenously over 60 minutes Days 1, 8, 15, 22 of 28 Day Cycle. | Drug | Phase I, Arm A, Phase I, Arm B, Phase II, Arm A, Phase II, Arm B |
| GemcitabineAlso: Gemzar, Gemcitabine Hydrochloride1000 mg/m^2 given intravenously over 1-1/2 hours Days 1, 8, and 15 of each 28 Day Cycle. | Drug | Phase I, Arm A, Phase I, Arm B, Phase II, Arm A, Phase II, Arm B, Phase II, Arm C |
| ErlotinibAlso: OSI-774, Tarceva, Erlotinib Hydrochloride100 mg by mouth daily. | Drug | Phase I, Arm B, Phase II, Arm B, Phase II, Arm C |
Primary outcome
MK-0646 Maximum Tolerable Dose
Time frame: up to 12 cycles
MK-0646 10 mg/kg was declared to be the MTD in combination with gemcitabine and 5 mg/kg the MTD in combination with Gemcitabine and erlotinib
Progression Free Survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Time interval (in months) from date of randomization until the date of first documented progression or date of death from any cause, whichever came first
3 secondary outcomes
Overall Survival
Time frame: From date of randomization until the date of death from any cause, assessed up to 100 months
Overall Response Rate
Time frame: From start of the treatment until disease progression/recurrence; or through study completion (average of 1 year)
Treatment Toxicity
Time frame: Through the treatment cycles
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29843755Abdel-Wahab R, Varadhachary GR, Bhosale PR, Wang X, Fogelman DR, Shroff RT, Overman MJ, Wolff RA, Javle M. Randomized, phase I/II study of gemcitabine plus IGF-1R antagonist (MK-0646) versus gemcitabine plus erlotinib with and without MK-0646 for advanced pancreatic adenocarcinoma. J Hematol Oncol. 2018 May 30;11(1):71. doi: 10.1186/s13045-018-0616-2.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Milind Javle, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MK-0646, Gemcitabine and Erlotinib in people with Pancreatic Cancer and Pancreatic Adenocarcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MK-0646 Maximum Tolerable Dose (time frame: up to 12 cycles). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00769483, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2020.