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 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

October 3, 2011
November 21, 2013
October 2011
November 2013   (final data collection date for primary outcome measure)
Number of dose limiting toxicities (DLTs) within a cohort [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01447225 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety Study of MM-121 in Combination With Multiple Anticancer Therapies in Patients With Advanced Solid Tumors
A Phase 1, Pharmacologic and Pharmacodynamic Study of MM-121 in Combination With Multiple Anticancer Therapies in Patients With Advanced Solid Tumors

To evaluate the safety and tolerability of escalating doses of MM-121 + certain anticancer therapies

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Solid Tumors
  • Drug: MM-121 (SAR256212) plus Gemcitabine
    MM-121 (SAR256212) (IV) plus Gemcitabine (IV)
  • Drug: MM-121 (SAR256212) plus Carboplatin
    MM-121 (SAR256212) (IV) plus Carboplatin (IV)
  • Drug: MM-121 (SAR256212) plus Pemetrexed
    MM-121 (SAR256212) (IV) plus Pemetrexed (IV)
  • Drug: MM-121 (SAR256212) plus Cabazitaxel
    MM-121 (SAR256212) (IV) plus Cabazitaxel(IV)
  • Experimental: MM-121 plus Gemcitabine
    Intervention: Drug: MM-121 (SAR256212) plus Gemcitabine
  • Experimental: MM-121 plus Carboplatin
    Intervention: Drug: MM-121 (SAR256212) plus Carboplatin
  • Experimental: MM-121 plus Pemetrexed
    Intervention: Drug: MM-121 (SAR256212) plus Pemetrexed
  • Experimental: MM-121 plus Cabazitaxel
    Intervention: Drug: MM-121 (SAR256212) plus Cabazitaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
48
January 2014
November 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   France
 
NCT01447225
MM-121-06-01-06 (TCD11694)
No
Merrimack Pharmaceuticals
Merrimack Pharmaceuticals
Sanofi
Study Director: Victor Moyo, MD Merrimack Pharmaceuticals
Merrimack Pharmaceuticals
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP