A Phase 1 Study of MM-141 in Patients With Advanced Solid Tumors

Status: Recruiting
Phase: Phase 1
Diagnosis: Solid Tumor/Phase I
NCT ID: NCT01733004 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID:

 

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.

 

Conducting Institutions:
Massachusetts General Hospital

Overall PI:
Steven Isakoff, MD, PhD, Massachusetts General Hospital

Site-responsible Investigators:

Contacts:
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

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
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