- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01733004
A Phase 1 Study of MM-141 in Patients With Advanced Solid Tumors
August 3, 2016 updated by: Merrimack Pharmaceuticals
This study is a Phase 1 and pharmacologic open-labeled dose-escalation trial using a "3+3" design, evaluating MM-141 at varying dose levels and frequencies.
Study Overview
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Villejuif, France
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Georgia
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Marietta, Georgia, United States
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Massachusetts
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Boston, Massachusetts, United States
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Michigan
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Detroit, Michigan, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Advanced malignant solid tumors for which no curative therapy exists that has recurred or pgrogressed following standard therapy
- Eighteen years of age or above
- Able to understand and sign an informed consent (or have a legal representative who is able to do so)
- Measurable disease according to RECIST v1.1
- ECOG Performance Score of 0 or 1
- Adequate bone marrow, hepatic, renal and cardiac function
- Willing to abstain from sexual intercourse or to use an effective form of contraception during the study and for 90 days following the last dose of MM-141
Exclusion Criteria:
- Active infection or fever > 38.5°C during screening visits or on the first scheduled day of dosing
- Symptomatic CNS disease
- Received other recent antitumor therapy
- Pregnant or breast feeding
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Arm A
MM-141 monotherapy
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Experimental: Arm B
MM-141 and Everolimus
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Experimental: Arm C
MM-141 and Abraxane and Gemcitabine
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Severity and number of adverse events related to escalating doses of MM-141
Time Frame: 2 years
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Determine the Phase II dose based either on the maximum tolerated dose (MTD) or recommended dose in patients with advanced solid malignancies.
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2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Chrystal Louis, MD, MPH, Merrimack Pharmaceuticals
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2012
Primary Completion (Actual)
January 1, 2016
Study Registration Dates
First Submitted
November 20, 2012
First Submitted That Met QC Criteria
November 20, 2012
First Posted (Estimate)
November 26, 2012
Study Record Updates
Last Update Posted (Estimate)
August 4, 2016
Last Update Submitted That Met QC Criteria
August 3, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MM-141-01-01-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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