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

Primary Purpose

Hepatocellular Carcinoma

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
MM-141
Sponsored by
Merrimack Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Cancer, Hepatocellular Carcinoma, Oncology, Phase I, ErbB3, IGF-1R, Everolimus, Gemcitabine, Abraxane

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Arm A

Arm B

Arm C

Arm Description

MM-141 monotherapy

MM-141 and Everolimus

MM-141 and Abraxane and Gemcitabine

Outcomes

Primary Outcome Measures

Severity and number of adverse events related to escalating doses of MM-141
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

Full Information

First Posted
November 20, 2012
Last Updated
August 3, 2016
Sponsor
Merrimack Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01733004
Brief Title
A Phase 1 Study of MM-141 in Patients With Advanced Solid Tumors
Official Title
A Phase 1 Study of MM-141 in Patients With Advanced Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merrimack Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Cancer, Hepatocellular Carcinoma, Oncology, Phase I, ErbB3, IGF-1R, Everolimus, Gemcitabine, Abraxane

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
MM-141 monotherapy
Arm Title
Arm B
Arm Type
Experimental
Arm Description
MM-141 and Everolimus
Arm Title
Arm C
Arm Type
Experimental
Arm Description
MM-141 and Abraxane and Gemcitabine
Intervention Type
Drug
Intervention Name(s)
MM-141
Primary Outcome Measure Information:
Title
Severity and number of adverse events related to escalating doses of MM-141
Description
Determine the Phase II dose based either on the maximum tolerated dose (MTD) or recommended dose in patients with advanced solid malignancies.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chrystal Louis, MD, MPH
Organizational Affiliation
Merrimack Pharmaceuticals
Official's Role
Study Director
Facility Information:
City
Marietta
State/Province
Georgia
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
City
Detroit
State/Province
Michigan
Country
United States
City
Villejuif
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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