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

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ClinicalTrials.gov Identifier: NCT01733004
Recruitment Status : Completed
First Posted : November 26, 2012
Last Update Posted : August 4, 2016
Information provided by (Responsible Party):
Merrimack Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: MM-141 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of MM-141 in Patients With Advanced Solid Tumors
Study Start Date : November 2012
Primary Completion Date : January 2016

Arm Intervention/treatment
Experimental: Arm A
MM-141 monotherapy
Drug: MM-141
Experimental: Arm B
MM-141 and Everolimus
Drug: MM-141
Experimental: Arm C
MM-141 and Abraxane and Gemcitabine
Drug: MM-141

Primary Outcome Measures :
  1. Severity and number of adverse events related to escalating doses of MM-141 [ Time Frame: 2 years ]
    Determine the Phase II dose based either on the maximum tolerated dose (MTD) or recommended dose in patients with advanced solid malignancies.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01733004

United States, Georgia
Marietta, Georgia, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Michigan
Detroit, Michigan, United States
Villejuif, France
Sponsors and Collaborators
Merrimack Pharmaceuticals
Study Director: Chrystal Louis, MD, MPH Merrimack Pharmaceuticals

Responsible Party: Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01733004     History of Changes
Other Study ID Numbers: MM-141-01-01-01
First Posted: November 26, 2012    Key Record Dates
Last Update Posted: August 4, 2016
Last Verified: August 2016

Keywords provided by Merrimack Pharmaceuticals:
Hepatocellular Carcinoma
Phase I

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases