PANCREASPhase 2NCT01169649
Study of MK-2206 in Patients With Metastatic Neuroendocrine Tumors (NET)
A Phase 2 study testing MK-2206 in people with PANCREAS and Neuroendocrine, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to test a new drug called MK-2206. This study is a phase II study. In cancer studies, a phase II study is to find out what effects, good and/or bad, a new treatment has against a certain type of cancer. MK-2206 is an oral medication known as a targeted therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PANCREAS, Neuroendocrine
- What is being tested?
- MK-2206
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Feb 2014
- Phase
- Phase 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
- Patients with histologically or cytologically confirmed moderately to well differentiated metastatic or unresectable carcinoid or islet cell tumors.
- Patient has at least one measurable lesion greater than or equal to 20 mm on CT or MRI imaging.
- Patients who are on therapy with a somatostatin analog are eligible for entry but must be on a stable dose for at least 3 months with no evidence of tumor shrinkage during that time period.
- Patient ≥18 years of age on the day of signing informed consent.
- Patient has performance status 0-1 on the ECOG Performance Scale.
- Patient has adequate organ function as indicated by the following laboratory values:
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- Absolute Neutrophil Count (ANC)≥1,500/mcL
- Platelets ≥100,000/mcL
- Hemoglobin ≥9 g/dL
- Serum Creatinine ≤2 times the upper limit of normal (ULN)/ OR calculated CrCl ≥60 mL/min (patients with creatinine levels ≥2 times the ULN only). Patient may not be on dialysis
- Serum total bilirubin ≤1.5 times the ULN
- AST (SGOT) and ALT (SGPT) ≤5 times the ULN
- HgbA1c ≤ 8%
- Fasting Glucose ≤120 mg/dl
- Creatinine clearance should be calculated by the Cockcroft-Gault method.Fasting is defined as at least 4 hours without oral intake.
- Patient has voluntarily agreed to participate by giving written informed consent.
- Previous local therapy (e.g. chemoembolization or bland embolization) is allowed if completed > 6 weeks or 5X half-life prior to study entry. For patients who received local therapy prior to study entry, there must be either documented growth of measurable disease within the embolization field or outside of the embolization field, or both, prior to study entry if the area of the embolization field was the only site of measurable disease.
- Previous chemotherapy, radiotherapy, and/or biologic therapy, including investigational agents, is/are allowed if completed > 4 weeks prior to study entry (>6 weeks if last regimen contained bevacizumab, BCNU or mitomycin C, and > 6 weeks from last dose of radiation therapy or radiopharmaceutical.
- Patients must not have disease that is currently amenable to curative surgery. Prior surgery is allowed no less than 6 weeks prior to study entry.
- Patients with diabetes mellitus are eligible for study entry but must have controlled diabetes as defined by hemoglobin A1c <8.0% within 2 weeks of initiation of protocol therapy.
Who cannot join
- Patient has toxicities from prior therapies that have not resolved to grade 1 or grade 0.
- Patient has known active CNS metastases and/or carcinomatous meningitis are excluded. However, patients with CNS metastases who have completed a course of therapy would be eligible for the study provided they are clinically stable for 1 month prior to entry as defined as: (1) no evidence of new or enlarging CNS metastasis (2) off steroids that are used to minimize surrounding brain edema.
- Patient has an active malignancy of metastatic potential other than the known carcinoid or islet cell tumor, for the past 3 years.
- Patient has a known hypersensitivity to the components of study drug (MK-2206) or its analogs that is not treatable by premedication with antihistamines and steroids.
- Patient has a condition, including but not limited to
- symptomatic congestive heart failure
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- unstable angina pectoris
- serious cardiac arrhythmia
- history or current evidence of a myocardial infarction during the last 6 months, and/or a current ECG tracing that is abnormal in the opinion of the treating investigator
- QTc prolongation >450 msec (Bazett's formula)
- Patient with evidence of clinically significant bradycardia (HR <50), or a history of clinically significant bradyarrhythmias such as sick sinus syndrome, 2nd degree AV block (Mobitz Type 2).
- Patient with uncontrolled hypertension (i.e., 160/90 mHg SiBP). Patients who are controlled on antihypertensive medication will be allowed to enter the study.
- Patient at significant risk for hypokalemia (e.g., patients on high dose diuretics, or with recurrent diarrhea)
- Patient is a known diabetic who is poorly controlled (HBAc>8%)
- Patient has a history or current evidence of any condition, therapy, or lab abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator.
- Patient has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Patient is, at the time of signing informed consent, a regular user (including -recreational use‖) of any illicit drugs or had a recent history (within the last year) of drug or alcohol abuse.
- Patient is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.
- Patient is known to be Human Immunodeficiency Virus (HIV)-positive
- Patient has known history of Hepatitis C or active Hepatitis A or B.
- Patient has symptomatic ascites or pleural effusion. A patient who is clinically stable following treatment for these conditions is eligible.
- Patient has prior treatment with an mTOR inhibitor such as afinitor, sirolimus, or temsirolimus.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: A Phase II Clinical and Translational Study of MK-2206 in Patients With Metastatic Neuroendocrine Tumors (NET)
The purpose of this study is to test a new drug called MK-2206. This study is a phase II study. In cancer studies, a phase II study is to find out what effects, good and/or bad, a new treatment has against a certain type of cancer.
MK-2206 is an oral medication known as a targeted therapy. By attaching to the target, we hope that MK-2206 may stop the cancer cells from further growth and dividing. This study will help find out if MK-2206 is a helpful drug when taken in patients with neuroendocrine tumor.
- Conditions
- PANCREAS, Neuroendocrine
- Being tested
- MK-2206
- Keywords
- MK-2206, Neuroendocrine Tumors, 10-067
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-2206Drug
MK-2206 will be given orally 200 mg qw as given in the prior Ph1 clinical trial that demonstrated safety, tolerability and adequate PK/PD values at this dose. Follow-up imaging scans will be performed every 12 weeks to evaluate response. Patients must take MK-2206 orally at least 2 hours before or 2 hours after food or a meal.
| Study group | Role | What they receive |
|---|---|---|
| islet cell carcinomas and carcinoid tumors | Experimental | This is an open label phase II study of MK-2206 administered to patients with metastatic neuroendocrine tumors. Receives: Drug: MK-2206 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response.
Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Measured: every 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionFeb 2014
- Study completionFeb 2014
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.
- Other trials for PANCREASStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Diane Reidy-Lagunes, MD,MS, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01169649
- Sponsor's protocol ID
- 10-067
- Status last verified
- Jan 2016
- First submitted
- 21 Jul 2010
- Last updated
- 18 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical and Translational Study of MK-2206 in Patients With Metastatic Neuroendocrine Tumors (NET)
- ClinicalTrials.gov ID
- NCT01169649
- Acronym / sponsor ID
- 10-067
- Conditions
- PANCREAS, Neuroendocrine
- Keywords
- MK-2206, Neuroendocrine Tumors, 10-067
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jul 2010
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 26 Jul 2010 (estimated)
- Results
- Posted 18 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test a new drug called MK-2206. This study is a phase II study. In cancer studies, a phase II study is to find out what effects, good and/or bad, a new treatment has against a certain type of cancer.
MK-2206 is an oral medication known as a targeted therapy. By attaching to the target, we hope that MK-2206 may stop the cancer cells from further growth and dividing. This study will help find out if MK-2206 is a helpful drug when taken in patients with neuroendocrine tumor.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| islet cell carcinomas and carcinoid tumors | Experimental | Drug: MK-2206This is an open label phase II study of MK-2206 administered to patients with metastatic neuroendocrine tumors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Patients with histologically or cytologically confirmed moderately to well differentiated metastatic or unresectable carcinoid or islet cell tumors.
- Patient has at least one measurable lesion greater than or equal to 20 mm on CT or MRI imaging.
- Patients who are on therapy with a somatostatin analog are eligible for entry but must be on a stable dose for at least 3 months with no evidence of tumor shrinkage during that time period.
- Patient ≥18 years of age on the day of signing informed consent.
- Patient has performance status 0-1 on the ECOG Performance Scale.
Key exclusion criteria (22 listed)
- Patient has toxicities from prior therapies that have not resolved to grade 1 or grade 0.
- Patient has known active CNS metastases and/or carcinomatous meningitis are excluded. However, patients with CNS metastases who have completed a course of therapy would be eligible for the study provided they are clinically stable for 1 month prior to entry as defined as: (1) no evidence of new or enlarging CNS metastasis (2) off steroids that are used to minimize surrounding brain edema.
- Patient has an active malignancy of metastatic potential other than the known carcinoid or islet cell tumor, for the past 3 years.
- Patient has a known hypersensitivity to the components of study drug (MK-2206) or its analogs that is not treatable by premedication with antihistamines and steroids.
- Patient has a condition, including but not limited to
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-2206MK-2206 will be given orally 200 mg qw as given in the prior Ph1 clinical trial that demonstrated safety, tolerability and adequate PK/PD values at this dose. Follow-up imaging scans will be performed every 12 weeks to evaluate response. Patients must take MK-2206 orally at least 2 hours before or 2 hours after food or a meal. | Drug | islet cell carcinomas and carcinoid tumors |
Primary outcome
Overall Response.
Time frame: every 12 weeks
Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan-Kettering Cancer CenterLink 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.
Diane Reidy-Lagunes, MD,MS principal investigator
Memorial Sloan Kettering 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 2 study testing MK-2206 in people with PANCREAS and Neuroendocrine, run by Memorial Sloan Kettering 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 20 inclusion and 22 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 18 Feb 2016. 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 phase mean?
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 18 Feb 2016). 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?
Overall Response. (time frame: every 12 weeks). 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 18 Feb 2016.