A Phase 1, Pharmacologic and Pharmacodynamic Study of MM-121 in Combination With Multiple Anticancer Therapies in Patients With Advanced Solid Tumors
18 Years
N/A
Both
Solid Tumors
Trial Information
A Phase 1, Pharmacologic and Pharmacodynamic Study of MM-121 in Combination With Multiple Anticancer Therapies in Patients With Advanced Solid Tumors
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of dose limiting toxicities (DLTs) within a cohort
Outcome Time Frame:
24 months
Safety Issue:
Yes
Principal Investigator
Victor Moyo, MD
Investigator Role:
Study Director
Investigator Affiliation:
Merrimack Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
MM-121-06-01-06 (TCD11694)
NCT ID:
NCT01447225
Start Date:
October 2011
Completion Date:
February 2014
Related Keywords:
- Solid Tumors
- Advanced-stage
- Solid Tumors
- MM-121
- Carboplatin
- Pemetrexed
- Gemcitabine
- Cabazitaxel
- ErbB3
- Phase I
- Cancer
- Neoplasms
Name | Location |
|---|---|
| Albany, New York 12208 | |
| Cleveland, Ohio 44195 | |
| Philadelphia, Pennsylvania 19104 | |
| Indianapolis, Indiana |
