Pancreatic CancerPhase 1NCT00968604
C-VISA BikDD: Liposome in Advanced Pancreatic Cancer
A Phase 1 study testing BikDD Nanoparticle in people with Pancreatic Cancer, run by M.D. Anderson Cancer Center.
Trial summary
The goal of this clinical research study is to find the highest tolerable dose of BikDD nanoparticle that can be given to patients with advanced cancer of the pancreas. The safety of this drug will also be studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- BikDD Nanoparticle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Mar 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Patients must have histologically or cytologically confirmed advanced pancreatic adenocarcinoma that is unresectable or metastatic.
- Patient must have received prior gemcitabine or a regimen containing oxaliplatin, irinotecan, and 5-FU with or without leucovorin for treatment of advanced or metastatic disease, unless the patient refused such treatment. Up to two prior chemotherapeutic regimens are permitted.
- Patients must have measurable disease including liver metastases >/= 2.0 cm amenable to percutaneous CT or U/S guided biopsy and must agree to undergo two liver biopsies.
- Minimum of three weeks since any major surgery, radiation, or systemic anticancer therapy.
- Any clinically significant residual adverse events from any prior anticancer therapy must have resolved to grade </= 1 or baseline as per the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
- Age >/=18 years. Because no dosing or adverse event data are currently available on the use of gene therapy in patients < 18 years of age, children are excluded from this study.
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- ECOG performance status 0 or 1.
- Adequate hematologic, hepatic and renal parameters: leukocytes >/= 3,000/microliter, absolute neutrophil count >/= 1,500/microliter, platelets >/= 100,000/microliter, hemoglobin >/= 9g/dL, total bilirubin </= 1.5 mg/dL, AST and ALT </= 3 x upper limit of normal (ULN) for subjects with documented liver metastases; AST and ALT </= 2.5 x ULN for subjects without evidence of liver metastases, creatinine </= 1.5 mg/dL and calculated creatinine clearance of >/= 60 mL/min.
- PT/PTT are within normal limits.
- Women of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days prior to treatment. Women must be surgically sterile or have been amenorrheic for at least 12 months to be considered of non-childbearing potential.
- Women of childbearing potential and men must agree to use double barrier contraception prior to study entry and continuing for 30 days after the last dose of study drug.
- Signed written informed consent/authorization form.
Who cannot join
- Prior treatment with any investigational drug within the preceding 3 weeks of Cycle 1, Day 1.
- Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases (Brain imaging studies are not required if the patient does not have a history of brain metastases and has no neurological signs or symptoms).
- Other malignancies within the past 3 years of Cycle 1, Day 1 except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin.
- Patients who have any known severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study.
- A known history of HIV seropositivity.
- Women who are pregnant or breast feeding.
- History of MI within 6 months of Cycle 1, Day 1, angina, history of arrhythmias on active therapy, patients with LV ejection fraction </= 50%.
About this study
Official title: A Phase I Open-Label Dose Escalation Study to Assess the Safety and Tolerability of the BikDD Nanoparticle in Patients With Advanced Pancreatic Cancer
The goal of this clinical research study is to find the highest tolerable dose of BikDD nanoparticle that can be given to patients with advanced cancer of the pancreas. The safety of this drug will also be studied.
Read the detailed description
The Study Drug:
BikDD is a modified gene product that is designed to make cancer cells destroy themselves. Delivering BikDD in a fat molecule (a BikDD nanoparticle) may improve the delivery of the gene product into the cells. This may help to stop or slow the growth of pancreatic cancer. This is the first study using BikDD nanoparticle in humans.
Study Drug Dose Level:
If you are found to be eligible to take part in this study, you will be assigned to a dose level of BikDD nanoparticle based on when you joined this study. Different dose levels of BikDD nanoparticle will be tested. Three (3) participants will be enrolled at each dose level. The first group of participants will receive a low dose level. Each new group will receive a higher dose level, if no intolerable side effects were seen. If intolerable side effects were seen, then the next group of participants will receive a lower dose. This will continue until the highest tolerable dose of BikDD nanoparticle is found.
The dose of study drug that you receive will never be increased. However, if you have side effects, your dose of study drug may be lowered. Your doctor will discuss with you which dose you will receive.
Study Drug Administration:
There will be 28 days in each cycle. The study visit schedule is described below. In certain circumstances, with the permission of your doctor, the study visits may occur up to 2 or 3 days earlier or later than described below.
On Days 1, 8, 15, 22 of each cycle, you will receive BikDD nanoparticle through a needle in your vein over about 10 minutes.
Study Visits:
Liver Tumor Biopsy:
Before you receive the study drug, you will have a biopsy of the liver tumor. Researchers will compare this biopsy with a later biopsy to learn if the BikDD nanoparticle will be able to reach the tumor and what effect it is having on the cancer.
You will be awake during the biopsy. A radiologist will find the tumor with the help of a scan such as an ultrasound or CT scan. You will receive a local anesthetic. A needle will be inserted through the skin into the tumor, and tissue sample(s) will be taken. You will receive fluids and drugs for relaxation and/or pain as needed through a needle in your arm or hand.
On Days 1, 8, 15, 22 of Cycle 1, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your weight.
- Your vital signs will be measured 5 times.
- Your performance status will be recorded.
- You will be asked about any drugs and/or supplements you are taking or have taken since your last visit.
- You will be asked about any side effects you may be experiencing.
- Blood (about 2-3 tablespoons) will be drawn for routine tests.
- On Day 1 only, blood (about 2 teaspoons each time) will be drawn 9 times for pharmacokinetic (PK) testing. PK testing measures the amount of study drug in the body at different time points.
On Day 2 of Cycle 1, blood (about 2 teaspoons) will be drawn 1 time for PK testing.
On Days 4, 11, 18, and 25 of Cycle 1, the following tests and procedures will be performed:
- Blood (about 2-3 tablespoons) will be drawn for routine tests.
- You will be asked about any side effects you may be having.
On Day 24 of Cycle 1, you will have a biopsy of the liver tumor to learn if BikDD nanoparticle is reaching the tumor and its effect on cancer. If for any reason the biopsy can't be performed then, you may be asked to have the biopsy 6-8 days later.
On Day 1 of Cycle 2, the following tests and procedures will be performed:
Your medical history will be recorded, including any drugs and/or supplements you are taking or have taken since your last visit.
- You will have a physical exam, including measurement of your weight.
- Your vital signs will be measured 5 times.
- Your performance status will be recorded.
- You will be asked about any side effects you may be experiencing.
- Blood (about 2-3 tablespoons) and urine will be collected for routine tests.
- You will have an ECG.
On Days 8, 15, and 22 of Cycle 2, the following tests and procedures will be performed:
- Blood (about 1 tablespoon) will be drawn for routine tests.
- Your vital signs will be measured 5 times.
- You will be asked about any side effects you may be experiencing.
At the end of Cycle 2 and every other cycle (Cycle 4, 6, 8, and so on), you will have a CT scan or MRI of the chest, abdomen, and pelvis to check the status of the disease. Blood (about 1 teaspoon) will be drawn to measure your CA 19-9 level. Because it may take some time for the effects BikDD may have on the tumor to be known, the study doctor may decide to continue the BikDD even if the scan/MRI shows the tumor is worse. In this case, you will have another CT scan or MRI of the chest, abdomen, and pelvis 4 to 6 weeks later. If the cancer is worse, you will stop BikDD.
On Day 1 of Cycles 3 and beyond, the following tests and procedures will be performed:
- Your medical history will be recorded, including any drugs and/or supplements you are taking or have taken since your last visit.
- You will have a physical exam, including measurement of your weight.
- Your vital signs will be measured 5 times.
- Your performance status will be recorded.
- You will be asked about any side effects you may be experiencing.
- You will have an ECG.
- Blood (about 2-3 tablespoons) and urine will be collected for routine tests.
On Days 8, 15, and 22 of Cycles 3 and beyond, the following tests and procedures will be performed:
- Your vital signs will be measured 5 times.
- You will be asked about any side effects you may be experiencing.
- Blood (about 2-3 tablespoons) will be drawn for routine tests.
Length of Study:
You may continue to receive the study drug as long as your doctor thinks it is in your best interest. If all of the cancer disappears, you will receive 2 extra cycles of study drug and then stop study drug. You will be taken off study if the disease gets worse, your doctor decides that it is in your best interest to stop the drug, or if you experience intolerable side effects.
End-of-Study Visit:
Once you stop the study drug for any reason, you will have an end-of-study visit. At this visit, the following tests and procedures will be performed.
- Your medical history will be recorded, including any drugs and/or supplements you are taking or have taken since your last visit.
- You will have a physical exam, including measurement of your weight and vital signs
- Your performance status will be recorded.
- You will be asked about any side effects you may be experiencing.
- You will have an ECG.
- Blood (about 2-3 tablespoons) and urine will be collected for routine tests and to measure your CA 19-9 level.
- If you have not had one within the last 4 weeks, you will have a CT scan or MRI of the chest, abdomen, and pelvis to check the status of the disease
Once a week for at least 30 days after your last dose of study drug, you will be asked if you are experiencing any side effects. If you do not have a clinic visit already scheduled, you will be called. If you are called, it will take about 5-10 minutes.
If you experience any side effects, you may continue follow-up visits until the medical problem has gone away or stabilized.
Follow-Up:
Every 2 months from then on, the study staff will continue to see how you are doing, either at a routine clinic visit or by phone. If you are called, it will last about 5-10 minutes. If you move, you will also be asked to provide your new address and telephone number to your doctor.
This is an investigational study. BikDD nanoparticle is not FDA approved or commercially available. At this time, BikDD nanoparticle is only being used in research.
Up to 30 patients will take part in this study. All will be enrolled at M D Anderson.
- Conditions
- Pancreatic Cancer
- Being tested
- BikDD Nanoparticle
- Keywords
- Pancreatic Cancer, Pancreas, Liver, Liver Tumor Biopsy, BikDD Nanoparticle, C-VISA BikDD
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BikDD NanoparticleGenetic
Also called Bik gene product, Cholesterol liposome-based nanoparticle
Starting dose 0.04 mg/kg once weekly by vein over 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| BikDD Nanoparticle | Experimental | BikDD Nanoparticle starting dose 0.04 mg/kg once weekly by vein over 10 minutes. Receives: Genetic: BikDD Nanoparticle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of BikDD Nanoparticle in Patients with Advanced Pancreatic Cancer
The maximum tolerated dose (MTD) is defined as the maximal achievable dose level at which < 1/6 enrolled patients experiences dose-limiting toxicity.
Measured: Weekly during 28 day cycles
Dose-Limiting Toxicity (DLT)
Dose-limiting toxicity (DLT) defined as:
Any ≥ grade 3 hematologic and non-hematologic toxicity as per NCI CTCAE v. 4.0 with the following exceptions:
- Grade 3 or 4 lymphopenia unless persistent for >14 days or associated with single oral temperature of >38.3°C (101°F) or temp > 38°C (100.4°F) measured on two separate occasions one hour apart.
- Adverse events (Grade 3 or greater) for which a clinical cause unrelated to study drug is evident will not be considered DLTs. These will include: obstructive jaundice from stent occlusion, narcotic-induced constipation if symptom is present prior to study enrollment, anorexia or cachexia if present prior to study enrollment.
- Delay of Dose > 14 days due to toxicity.
Measured: Continuously during 28 day cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2009 (estimated)
- Study startMar 2015
- Primary completionMar 2017 (estimated)
- Study completionMar 2017 (estimated)
Why it stopped: Stability of the DNA when admixed with the liposome failed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Milind Javle, MD, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00968604
- Sponsor's protocol ID
- 2007-0762
- Other IDs
- 1 R21 CA135 60401A1, NCI-2011-00466
- Status last verified
- Apr 2019
- First submitted
- 28 Aug 2009
- Last updated
- 11 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Open-Label Dose Escalation Study to Assess the Safety and Tolerability of the BikDD Nanoparticle in Patients With Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00968604
- Acronym / sponsor ID
- 2007-0762
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic Cancer, Pancreas, Liver, Liver Tumor Biopsy, BikDD Nanoparticle, C-VISA BikDD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Stability of the DNA when admixed with the liposome failed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2015
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 31 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to find the highest tolerable dose of BikDD nanoparticle that can be given to patients with advanced cancer of the pancreas. The safety of this drug will also be studied.
Detailed description
The Study Drug:
BikDD is a modified gene product that is designed to make cancer cells destroy themselves. Delivering BikDD in a fat molecule (a BikDD nanoparticle) may improve the delivery of the gene product into the cells. This may help to stop or slow the growth of pancreatic cancer. This is the first study using BikDD nanoparticle in humans.
Study Drug Dose Level:
If you are found to be eligible to take part in this study, you will be assigned to a dose level of BikDD nanoparticle based on when you joined this study. Different dose levels of BikDD nanoparticle will be tested. Three (3) participants will be enrolled at each dose level. The first group of participants will receive a low dose level. Each new group will receive a higher dose level, if no intolerable side effects were seen. If intolerable side effects were seen, then the next group of participants will receive a lower dose. This will continue until the highest tolerable dose of BikDD nanoparticle is found.
The dose of study drug that you receive will never be increased. However, if you have side effects, your dose of study drug may be lowered. Your doctor will discuss with you which dose you will receive.
Study Drug Administration:
There will be 28 days in each cycle. The study visit schedule is described below. In certain circumstances, with the permission of your doctor, the study visits may occur up to 2 or 3 days earlier or later than described below.
On Days 1, 8, 15, 22 of each cycle, you will receive BikDD nanoparticle through a needle in your vein over about 10 minutes.
Study Visits:
Liver Tumor Biopsy:
Before you receive the study drug, you will have a biopsy of the liver tumor. Researchers will compare this biopsy with a later biopsy to learn if the BikDD nanoparticle will be able to reach the tumor and what effect it is having on the cancer.
You will be awake during the biopsy. A radiologist will find the tumor with the help of a scan such as an ultrasound or CT scan. You will receive a local anesthetic. A needle will be inserted through the skin into the tumor, and tissue sample(s) will be taken. You will receive fluids and drugs for relaxation and/or pain as needed through a needle in your arm or hand.
On Days 1, 8, 15, 22 of Cycle 1, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your weight.
- Your vital signs will be measured 5 times.
- Your performance status will be recorded.
- You will be asked about any drugs and/or supplements you are taking or have taken since your last visit.
- You will be asked about any side effects you may be experiencing.
- Blood (about 2-3 tablespoons) will be drawn for routine tests.
- On Day 1 only, blood (about 2 teaspoons each time) will be drawn 9 times for pharmacokinetic (PK) testing. PK testing measures the amount of study drug in the body at different time points.
On Day 2 of Cycle 1, blood (about 2 teaspoons) will be drawn 1 time for PK testing.
On Days 4, 11, 18, and 25 of Cycle 1, the following tests and procedures will be performed:
- Blood (about 2-3 tablespoons) will be drawn for routine tests.
- You will be asked about any side effects you may be having.
On Day 24 of Cycle 1, you will have a biopsy of the liver tumor to learn if BikDD nanoparticle is reaching the tumor and its effect on cancer. If for any reason the biopsy can't be performed then, you may be asked to have the biopsy 6-8 days later.
On Day 1 of Cycle 2, the following tests and procedures will be performed:
Your medical history will be recorded, including any drugs and/or supplements you are taking or have taken since your last visit.
- You will have a physical exam, including measurement of your weight.
- Your vital signs will be measured 5 times.
- Your performance status will be recorded.
- You will be asked about any side effects you may be experiencing.
- Blood (about 2-3 tablespoons) and urine will be collected for routine tests.
- You will have an ECG.
On Days 8, 15, and 22 of Cycle 2, the following tests and procedures will be performed:
- Blood (about 1 tablespoon) will be drawn for routine tests.
- Your vital signs will be measured 5 times.
- You will be asked about any side effects you may be experiencing.
At the end of Cycle 2 and every other cycle (Cycle 4, 6, 8, and so on), you will have a CT scan or MRI of the chest, abdomen, and pelvis to check the status of the disease. Blood (about 1 teaspoon) will be drawn to measure your CA 19-9 level. Because it may take some time for the effects BikDD may have on the tumor to be known, the study doctor may decide to continue the BikDD even if the scan/MRI shows the tumor is worse. In this case, you will have another CT scan or MRI of the chest, abdomen, and pelvis 4 to 6 weeks later. If the cancer is worse, you will stop BikDD.
On Day 1 of Cycles 3 and beyond, the following tests and procedures will be performed:
- Your medical history will be recorded, including any drugs and/or supplements you are taking or have taken since your last visit.
- You will have a physical exam, including measurement of your weight.
- Your vital signs will be measured 5 times.
- Your performance status will be recorded.
- You will be asked about any side effects you may be experiencing.
- You will have an ECG.
- Blood (about 2-3 tablespoons) and urine will be collected for routine tests.
On Days 8, 15, and 22 of Cycles 3 and beyond, the following tests and procedures will be performed:
- Your vital signs will be measured 5 times.
- You will be asked about any side effects you may be experiencing.
- Blood (about 2-3 tablespoons) will be drawn for routine tests.
Length of Study:
You may continue to receive the study drug as long as your doctor thinks it is in your best interest. If all of the cancer disappears, you will receive 2 extra cycles of study drug and then stop study drug. You will be taken off study if the disease gets worse, your doctor decides that it is in your best interest to stop the drug, or if you experience intolerable side effects.
End-of-Study Visit:
Once you stop the study drug for any reason, you will have an end-of-study visit. At this visit, the following tests and procedures will be performed.
- Your medical history will be recorded, including any drugs and/or supplements you are taking or have taken since your last visit.
- You will have a physical exam, including measurement of your weight and vital signs
- Your performance status will be recorded.
- You will be asked about any side effects you may be experiencing.
- You will have an ECG.
- Blood (about 2-3 tablespoons) and urine will be collected for routine tests and to measure your CA 19-9 level.
- If you have not had one within the last 4 weeks, you will have a CT scan or MRI of the chest, abdomen, and pelvis to check the status of the disease
Once a week for at least 30 days after your last dose of study drug, you will be asked if you are experiencing any side effects. If you do not have a clinic visit already scheduled, you will be called. If you are called, it will take about 5-10 minutes.
If you experience any side effects, you may continue follow-up visits until the medical problem has gone away or stabilized.
Follow-Up:
Every 2 months from then on, the study staff will continue to see how you are doing, either at a routine clinic visit or by phone. If you are called, it will last about 5-10 minutes. If you move, you will also be asked to provide your new address and telephone number to your doctor.
This is an investigational study. BikDD nanoparticle is not FDA approved or commercially available. At this time, BikDD nanoparticle is only being used in research.
Up to 30 patients will take part in this study. All will be enrolled at M D Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BikDD Nanoparticle | Experimental | Genetic: BikDD NanoparticleBikDD Nanoparticle starting dose 0.04 mg/kg once weekly by vein over 10 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients must have histologically or cytologically confirmed advanced pancreatic adenocarcinoma that is unresectable or metastatic.
- Patient must have received prior gemcitabine or a regimen containing oxaliplatin, irinotecan, and 5-FU with or without leucovorin for treatment of advanced or metastatic disease, unless the patient refused such treatment. Up to two prior chemotherapeutic regimens are permitted.
- Patients must have measurable disease including liver metastases >/= 2.0 cm amenable to percutaneous CT or U/S guided biopsy and must agree to undergo two liver biopsies.
- Minimum of three weeks since any major surgery, radiation, or systemic anticancer therapy.
- Any clinically significant residual adverse events from any prior anticancer therapy must have resolved to grade </= 1 or baseline as per the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
Key exclusion criteria (7 listed)
- Prior treatment with any investigational drug within the preceding 3 weeks of Cycle 1, Day 1.
- Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases (Brain imaging studies are not required if the patient does not have a history of brain metastases and has no neurological signs or symptoms).
- Other malignancies within the past 3 years of Cycle 1, Day 1 except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin.
- Patients who have any known severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study.
- A known history of HIV seropositivity.
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 |
|---|---|---|
| BikDD NanoparticleAlso: Bik gene product, Cholesterol liposome-based nanoparticleStarting dose 0.04 mg/kg once weekly by vein over 10 minutes. | Genetic | BikDD Nanoparticle |
Primary outcome
Maximum Tolerated Dose (MTD) of BikDD Nanoparticle in Patients with Advanced Pancreatic Cancer
Time frame: Weekly during 28 day cycles
The maximum tolerated dose (MTD) is defined as the maximal achievable dose level at which < 1/6 enrolled patients experiences dose-limiting toxicity.
Dose-Limiting Toxicity (DLT)
Time frame: Continuously during 28 day cycles
Dose-limiting toxicity (DLT) defined as: Any ≥ grade 3 hematologic and non-hematologic toxicity as per NCI CTCAE v. 4.0 with the following exceptions: 1. Grade 3 or 4 lymphopenia unless persistent for >14 days or associated with single oral temperature of >38.3°C (101°F) or temp > 38°C (100.4°F) measured on two separate occasions one hour apart. 2. Adverse events (Grade 3 or greater) for which a clinical cause unrelated to study drug is evident will not be considered DLTs. These will include: obstructive jaundice from stent occlusion, narcotic-induced constipation if symptom is present prior to study enrollment, anorexia or cachexia if present prior to study enrollment. 3. Delay of Dose > 14 days due to toxicity.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2019.
- 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 study chair
M.D. Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BikDD Nanoparticle in people with Pancreatic Cancer, run by M.D. Anderson Cancer Center.
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 12 inclusion and 7 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: withdrawn, as of the sponsor's last update on 11 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Maximum Tolerated Dose (MTD) of BikDD Nanoparticle in Patients with Advanced Pancreatic Cancer (time frame: Weekly during 28 day 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?
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 11 Apr 2019.