Neuroendocrine TumorsPhase 2NCT00610129
Clinical and Translational Study of MK-0646 in Patients With Metastatic Neuroendocrine Tumors (NET)
A Phase 2 study testing MK-0646 in people with Neuroendocrine Tumors and Metastatic Neuroendocrine Tumors, run by Memorial Sloan Kettering Cancer Center at 5 sites in United States.
Trial summary
The purpose of this study is to test a new drug for neuroendocrine tumors. We think that this new drug may help control your tumor. MK-0646 is a monoclonal antibody. An antibody is a protein that is able to attach to specific target on cancer cells. This target helps the cancer cells grow and divide. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors, Metastatic Neuroendocrine Tumors
- What is being tested?
- MK-0646
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 5 sitesUnited States
- Study dates
- Jan 2008to Jan 2010
- 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 metastatic neuroendocrine tumors (NET)
- Patients must have histologically or cytologically confirmed well differentiated (low to intermediate grade) neuroendocrine tumors. High grade or poorly differentiated (i.e., large or small cell variant), Merkel cell, medullary carcinoma of the thyroid, and adrenal gland malignancies (including paragangliomas) are excluded from this study.
- Patient has at least one measurable lesion greater than or equal to 20 mm or greater than 10 mm on spiral CT.
- Patients who are on therapy with a somatostatin analogue 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 is male or female.
- Patient ≥ or equal to 18 years of age on the day of signing informed consent.
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- Patient has performance status 0-2 on the ECOG Performance Scale.
- Patient has adequate organ function as indicated by the following laboratory values:
- Absolute Neutrophil Count (ANC) ≥ than or equal to 1,500/mcL
- platelets ≥ than or equal to 100,000/mcL
- Hemoglobin ≥ than or equal to 8 g/dL
- Serum Creatinine ≤ than or equal to 2 times the upper limit of normal (ULN)/ OR calculated CrCl ≥ than or equal to 60 mL/min (patients with creatinine levels ≥ than or equal to 2 times the ULN only). Patient may not be on dialysis
- Serum total bilirubin ≤ than or equal to 1.5 times the ULN
- AST (SGOT) and ALT (SGPT) ≤ than or equal to 5 times the ULN
- Prothrombin time (PT) Partial Thromboplastin time (PTT)
- ≤ than or equal to 1.2 times the ULN
- ≤than or equal to 1.2 times the ULN Creatinine clearance should be calculated by the Cockcroft-Gault method as follows:
- Male creatinine clearance = (140-age) x (weight in Kg)/(serum Cr x 72)
- Female creatinine clearance = ((140- age) x (weight in Kg)/(serum Cr x 72)) x 0.85
- Patient, or patient's legal representative, 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 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 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 CNS metastases and/or carcinomatous meningitis.
- Patient has known primary central nervous system tumor.
- Patient has a known hypersensitivity to the components of study drug (MK-0646) or its analogs that is not treatable by premedication with antihistamines and steroids.
- Patient has a condition, including but not limited to, serious active infection, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, or major psychiatric illness, which, in the opinion of the treating investigator, is likely to confound the results of the study, or makes participation not in the best interest of the patient.
- Patient has a history of a prior active malignancy within the past 5 years, with the exception of cervical intraepithelial neoplasia; basal cell carcinoma of the skin, adequately treated localized prostate carcinoma with PSA <1.0, or squamous cell carcinoma of the skin removed (or the more superficial keratoacanthoma).
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- Patient has known psychiatric or substance abuse disorders that would, in the opinion of the treating investigator, interfere with cooperation with the requirements of the trial.
- Patient is breastfeeding or pregnant (this will requires a negative test within 72 hours of initiation of therapy), or expecting to conceive within the projected duration of the study.
- Patient is not using adequate contraception.
- Patient is known to be Human Immunodeficiency Virus (HIV)-positive.
- Patient has known active Hepatitis B or C.
- Patient is concurrently using growth hormone (GH), or growth hormone inhibitors.
- Patient has prior treatment with IGF-1R inhibitors.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Memorial Sloan-Kettering at Basking Ridge
Basking Ridge, New Jersey, 07920
Memorial Sloan-Kettering Cancer Center @ Suffolk
Commack, New York, 11725
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Memorial Sloan-Kettering Cancer Center at Mercy Medical Center
Rockville Centre, New York, 11570
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center
Sleepy Hollow, New York, 10591
About this study
Official title: A Phase II Clinical and Translational Study of MK-0646 in Patients With Metastatic Neuroendocrine Tumors (NET)
The purpose of this study is to test a new drug for neuroendocrine tumors. We think that this new drug may help control your tumor.
MK-0646 is a monoclonal antibody. An antibody is a protein that is able to attach to specific target on cancer cells. This target helps the cancer cells grow and divide. By attaching to the target, it may stop the cancer cells from further growth and dividing. This study will help find out if MK-0646 is a helpful drug when taken in patients with neuroendocrine tumor.
This study is a phase 2 study. The purpose of a phase 2 study is to find out what effects, good and/or bad, MK-0646 has on metastatic neuroendocrine tumors.
- Being tested
- MK-0646
- Keywords
- MK-0646
- 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-0646Drug
MK-0646 (20 mg/mL) in sterilized solution for IV infusion (12.7 mL to deliver 12.0 mL) will be used for a dose of 10 mg/kg IV weekly administered over 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | MK-0646 Receives: Drug: MK-0646 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
in patients with metastatic carcinoid tumors and in metastatic islet cell tumors (parallel cohorts) when treated with MK-0646 alone.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionJan 2010
- Study completionJan 2010
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 Neuroendocrine TumorsStudies 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
- 25 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
- Leonard Saltz, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00610129
- Sponsor's protocol ID
- 07-162
- Status last verified
- Oct 2015
- First submitted
- 24 Jan 2008
- Last updated
- 20 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical and Translational Study of MK-0646 in Patients With Metastatic Neuroendocrine Tumors (NET)
- ClinicalTrials.gov ID
- NCT00610129
- Acronym / sponsor ID
- 07-162
- Keywords
- MK-0646
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jan 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 7 Feb 2008 (estimated)
- Results
- Posted 20 Nov 2015
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 for neuroendocrine tumors. We think that this new drug may help control your tumor.
MK-0646 is a monoclonal antibody. An antibody is a protein that is able to attach to specific target on cancer cells. This target helps the cancer cells grow and divide. By attaching to the target, it may stop the cancer cells from further growth and dividing. This study will help find out if MK-0646 is a helpful drug when taken in patients with neuroendocrine tumor.
This study is a phase 2 study. The purpose of a phase 2 study is to find out what effects, good and/or bad, MK-0646 has on metastatic neuroendocrine tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MK-0646MK-0646 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Patients with histologically or cytologically confirmed metastatic neuroendocrine tumors (NET)
- Patients must have histologically or cytologically confirmed well differentiated (low to intermediate grade) neuroendocrine tumors. High grade or poorly differentiated (i.e., large or small cell variant), Merkel cell, medullary carcinoma of the thyroid, and adrenal gland malignancies (including paragangliomas) are excluded from this study.
- Patient has at least one measurable lesion greater than or equal to 20 mm or greater than 10 mm on spiral CT.
- Patients who are on therapy with a somatostatin analogue 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 is male or female.
Key exclusion criteria (13 listed)
- Patient has toxicities from prior therapies that have not resolved to grade 1 or grade 0.
- Patient has known CNS metastases and/or carcinomatous meningitis.
- Patient has known primary central nervous system tumor.
- Patient has a known hypersensitivity to the components of study drug (MK-0646) or its analogs that is not treatable by premedication with antihistamines and steroids.
- Patient has a condition, including but not limited to, serious active infection, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, or major psychiatric illness, which, in the opinion of the treating investigator, is likely to confound the results of the study, or makes participation not in the best interest of the patient.
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-0646MK-0646 (20 mg/mL) in sterilized solution for IV infusion (12.7 mL to deliver 12.0 mL) will be used for a dose of 10 mg/kg IV weekly administered over 60 minutes. | Drug | 1 |
Primary outcome
Objective Response Rate (ORR)
Time frame: 2 years
in patients with metastatic carcinoid tumors and in metastatic islet cell tumors (parallel cohorts) when treated with MK-0646 alone.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
Related trials for Neuroendocrine Tumors
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A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity
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Enrolling by invitationObservational study
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RecruitingPhase 3
Somatostatin Analogues vs. Observation After Peptide Receptor Radionuclide Therapy (PRRT) in Nonfunctional Neuroendocrine Neoplasms
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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.
Leonard Saltz, MD principal investigator
Memorial Sloan Kettering Cancer Center
5 sites 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-0646 in people with Neuroendocrine Tumors and Metastatic Neuroendocrine Tumors, run by Memorial Sloan Kettering Cancer Center at 5 sites 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 24 inclusion and 13 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 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 20 Nov 2015). 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?
Objective Response Rate (ORR) (time frame: 2 years). 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 20 Nov 2015.