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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A

MM-141 monotherapy

Group Type EXPERIMENTAL

MM-141

Intervention Type DRUG

Arm B

MM-141 and Everolimus

Group Type EXPERIMENTAL

MM-141

Intervention Type DRUG

Arm C

MM-141 and Abraxane and Gemcitabine

Group Type EXPERIMENTAL

MM-141

Intervention Type DRUG

Interventions

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MM-141

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No