A Phase 1 Study of MM-141 in Patients With Advanced Solid Tumors
Conditions
Hepatocellular Carcinoma
Conditions: official terms
Carcinoma, Hepatocellular
Conditions: Keywords
Cancer, Hepatocellular Carcinoma, Oncology, Phase I, ErbB3, IGF-1R, Everolimus, Gemcitabine, Abraxane
Study Type
Interventional
Study Phase
Phase 1
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: MM-141
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Locations
Marietta, Georgia, United States
Status: Recruiting
Boston, Massachusetts, United States
Status: Recruiting
Detroit, Michigan, United States
Status: Recruiting
Villejuif, France
Status: Recruiting
Start Date
November 2012
Sponsors
Merrimack Pharmaceuticals
Source
Merrimack Pharmaceuticals
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page