Trial record 1 of 1 for:    NCT01447225
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Safety Study of MM-121 in Combination With Multiple Anticancer Therapies in Patients With Advanced Solid Tumors

This study has been completed.
Information provided by (Responsible Party):
Merrimack Pharmaceuticals Identifier:
First received: October 3, 2011
Last updated: February 3, 2016
Last verified: December 2015
To evaluate the safety and tolerability of escalating doses of MM-121 + certain anticancer therapies

Condition Intervention Phase
Solid Tumors
Drug: MM-121 (SAR256212) plus Gemcitabine
Drug: MM-121 (SAR256212) plus Carboplatin
Drug: MM-121 (SAR256212) plus Pemetrexed
Drug: MM-121 (SAR256212) plus Cabazitaxel
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1, Pharmacologic and Pharmacodynamic Study of MM-121 in Combination With Multiple Anticancer Therapies in Patients With Advanced Solid Tumors

Resource links provided by NLM:

Further study details as provided by Merrimack Pharmaceuticals:

Primary Outcome Measures:
  • Number of dose limiting toxicities (DLTs) within a cohort [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Enrollment: 43
Study Start Date: October 2011
Study Completion Date: December 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MM-121 plus Gemcitabine Drug: MM-121 (SAR256212) plus Gemcitabine
MM-121 (SAR256212) (IV) plus Gemcitabine (IV)
Experimental: MM-121 plus Carboplatin Drug: MM-121 (SAR256212) plus Carboplatin
MM-121 (SAR256212) (IV) plus Carboplatin (IV)
Experimental: MM-121 plus Pemetrexed Drug: MM-121 (SAR256212) plus Pemetrexed
MM-121 (SAR256212) (IV) plus Pemetrexed (IV)
Experimental: MM-121 plus Cabazitaxel Drug: MM-121 (SAR256212) plus Cabazitaxel
MM-121 (SAR256212) (IV) plus Cabazitaxel(IV)

Detailed Description:
This study is a Phase 1 and pharmacologic dose-escalation trial of MM-121 + certain anticancer therapies. The dose-escalation portion of the study employs a 3 + 3 design to assess the safety, tolerability, and pharmacokinetics of MM-121 administered weekly in combination with certain anticancer therapies in patients with advanced/recurrent cancer. Doses of MM-121 will be escalated when given in combination with a fixed dose of anticancer therapy in this study until either the MTD is identified or the combination is shown to be tolerable at the highest planned doses.

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

Inclusion Criteria:

  • Advanced-stage solid tumors
  • ≥ 18 years of age
  • Adequate liver and kidney function

Exclusion Criteria:

  • Any other active malignancy
  • No known HIV, Hepatitis C or B
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01447225

United States, Indiana
Lafayette, Indiana, United States, 47905
United States, New York
Buffalo, New York, United States, 14263
United States, Ohio
Cincinnati, Ohio, United States, 45267
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19111
Villejuif, France
Sponsors and Collaborators
Merrimack Pharmaceuticals
Study Director: Victor Moyo, MD Merrimack Pharmaceuticals
  More Information

Responsible Party: Merrimack Pharmaceuticals Identifier: NCT01447225     History of Changes
Other Study ID Numbers: MM-121-06-01-06 (TCD11694) 
Study First Received: October 3, 2011
Last Updated: February 3, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Merrimack Pharmaceuticals:
Solid Tumors
Phase I

Additional relevant MeSH terms:
Antibodies, Monoclonal
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors processed this record on August 24, 2016