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

Merrimack Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Hepatocellular Carcinoma

Treatments: Drug: MM-141

Study type: Interventional

Funder types: Industry

Identifiers

NCT01733004

MM-141-01-01-01

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 3 patient groups

Arm A

Experimental group

Description:

MM-141 monotherapy

Treatment:

Drug: MM-141

Arm B

Experimental group

Description:

MM-141 and Everolimus

Treatment:

Drug: MM-141

Arm C

Experimental group

Description:

MM-141 and Abraxane and Gemcitabine

Treatment:

Drug: MM-141