Safety Study of MM-121 in Combination With Multiple Anticancer Therapies in Patients With Advanced Solid Tumors

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01447225
First received: October 3, 2011
Last updated: November 21, 2013
Last verified: November 2013
  Purpose

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 ]

Estimated Enrollment: 48
Study Start Date: October 2011
Estimated Study Completion Date: January 2014
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01447225

Locations
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
France
Villejuif, France
Sponsors and Collaborators
Merrimack Pharmaceuticals
Sanofi
Investigators
Study Director: Victor Moyo, MD Merrimack Pharmaceuticals
  More Information

No publications provided

Responsible Party: Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01447225     History of Changes
Other Study ID Numbers: MM-121-06-01-06 (TCD11694)
Study First Received: October 3, 2011
Last Updated: November 21, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Merrimack Pharmaceuticals:
Advanced-stage
Solid Tumors
MM-121
Carboplatin
Pemetrexed
Gemcitabine
Cabazitaxel
ErbB3
Phase I
Cancer

Additional relevant MeSH terms:
Neoplasms
Gemcitabine
Pemetrexed
Carboplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Folic Acid Antagonists

ClinicalTrials.gov processed this record on September 30, 2014