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:
Merrimack Pharmaceuticals
Collaborator:
Sanofi
Information provided by (Responsible Party):
Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01447225
First received: October 3, 2011
Last updated: March 28, 2013
Last verified: March 2013
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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:
MedlinePlus related topics:
Cancer
Drug Information available for:
Carboplatin
Gemcitabine
Gemcitabine hydrochloride
Pemetrexed
Pemetrexed disodium
Cabazitaxel
U.S. FDA Resources
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: | February 2014 |
| Estimated Primary Completion Date: | October 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
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: | March 28, 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 May 19, 2013