Phase 1
Completed N=43
Safety Study of MM-121 in Combination With Multiple Anticancer Therapies in Patients With Advanced Solid Tumors
Source: ClinicalTrials.gov NCT01447225 ↗Enrolled (actual)
43
Serious AEs
48.8%
Results posted
Sep 2016
Primary outcomePrimary: To Evaluate the Safety and Tolerability of Escalating Doses of the MM-121 Anticancer Therapies — 3; 8; 5; 3 participants reporting adverse events
Summary
To evaluate the safety and tolerability of escalating doses of MM-121 + certain anticancer therapies
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Evaluate the Safety and Tolerability of Escalating Doses of the MM-121 Anticancer Therapies |
3; 8; 5; 3; 3; 3 | — |
| PRIMARY To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: MM-121 Doses |
40; 40; 40; 40; 20; 20 | — |
| PRIMARY To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: Gemcitabine |
1000 | — |
| PRIMARY To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: Carboplatin |
5 | — |
| PRIMARY To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: Pemetrexed |
500 | — |
| PRIMARY To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: Cabazitaxel |
25 | — |
| PRIMARY To Characterize Dose-limiting Toxicities (DLTs) Associated With the Combination of MM-121 With Anticancer Therapies |
0; 1; 1; 0; 0; 0 | — |
| SECONDARY Objective Response Rate |
0; 2; 0; 0; 0; 0 | — |
| SECONDARY Pharmacokinetics |
560; 554.8; 900.7; 677.1; 1033.4; 1107.2 | — |
| SECONDARY Pharmacokinetics (AUClast) |
39666.4; 49749.6; 59984.1; 51995.1; 72132.1; 100309.9 | — |
| SECONDARY Immunogenicity |
NA; NA; NA; NA; NA; NA | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01447225). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.