Phase 2
Completed N=162
A Study of MM-121 Combination Therapy in Patients With Advanced Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov NCT00994123 ↗Enrolled (actual)
162
Serious AEs
45.7%
Results posted
Aug 2016
Primary outcomePrimary: Phase 1: To Determine the Recommended Phase 2 Dose of the MM-121 + Erlotinib Combination Based Upon Either the Maximum Tolerated Dose (MTD) or the Maximum Feasible Dose of the Combination in Patients With NSCLC. — 0; 0; 1; 1 participants reporting DLTs
Summary
A Phase 1-2 study of MM-121 in combination with standard therapy for non-small cell lung cancer (NSCLC).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase 1: To Determine the Recommended Phase 2 Dose of the MM-121 + Erlotinib Combination Based Upon Either the Maximum Tolerated Dose (MTD) or the Maximum Feasible Dose of the Combination in Patients With NSCLC. |
0; 0; 1; 1; 1; 0 | — |
| PRIMARY Phase 1: Determine the Maximum Tolerated Dose Dependent on Reports of Dose-limiting Toxicities |
NA | — |
| PRIMARY Phase 2: Progression-free Survival of the MM-121 + Erlotinib Combination |
8.1; 7.7 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with locally advanced or metastatic non-small cell lung cancer.
- Patients must be >/= 18 years of age.
- Patients must have adequate Performance Status (PS) as measured by ECOG and adequate end organ function.
Exclusion Criteria
- Patients with a recent history (within 5 years) of another malignancy.
- Patients who are pregnant or nursing.
- Patients with clinically significant heart failure.
- Patients with clinically significant eye or gastrointestinal abnormalities.
Data sourced from ClinicalTrials.gov (NCT00994123). 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.