A Phase 1 Study of MM-141 in Patients With Advanced Solid Tumors
- Registration Number
- NCT01733004
- Lead Sponsor
- Merrimack Pharmaceuticals
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm B MM-141 MM-141 and Everolimus Arm C MM-141 MM-141 and Abraxane and Gemcitabine Arm A MM-141 MM-141 monotherapy
- Primary Outcome Measures
Name Time Method Severity and number of adverse events related to escalating doses of MM-141 2 years Determine the Phase II dose based either on the maximum tolerated dose (MTD) or recommended dose in patients with advanced solid malignancies.
- Secondary Outcome Measures
Name Time Method