Phase 1
Completed N=41
A Study of MM-121 in Combination With Paclitaxel in Patients With Advanced Gynecologic and Breast Cancers
Ovarian Cancer · Endometrial Cancer · Locally Advanced/Metastatic Her2 Non Overexpressing Breast Cancer
Source: ClinicalTrials.gov NCT01209195 ↗
Enrolled (actual)
41
Serious AEs
39.0%
Results posted
Sep 2016
Primary outcomePrimary: Dose Escalation: To Evaluate the Safety and Tolerability of Escalating Doses of the MM-121 Plus Paclitaxel Combination Via Reporting of Dose-limiting Toxicity (DLT) — 0; 1; 0; 0 participants reporting DLTs
Summary
This study was a Phase 1 and pharmacologic open-labeled dose-escalation trial of MM-121 in combination with paclitaxel using a "3+3" design.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dose Escalation: To Evaluate the Safety and Tolerability of Escalating Doses of the MM-121 Plus Paclitaxel Combination Via Reporting of Dose-limiting Toxicity (DLT) |
0; 1; 0; 0; 0; 0 | — |
| PRIMARY To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Paclitaxel: MM-121 Dose Level |
40; 40; 20; 20 | — |
| PRIMARY To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Paclitaxel: Paclitaxel Dose Level |
80; 80 | — |
| SECONDARY To Characterize the Efficacy of the Combination of MM-121 and Paclitaxel Using Objective Response Rate |
1; 2; 3; 3; 3; 2 | — |
| SECONDARY To Determine the Pharmacokinetics (PK) of MM-121 When Administered in Combination With Paclitaxel |
445.7; 903.5; 1081.1; 1134.5 | — |
| SECONDARY Pharmacokinetic Parameters (AUClast) |
39252.9; 77137.6; 102263.1; 96043.0 | — |
| SECONDARY Immunogenicity |
NA; NA; NA; NA; NA; NA | — |
Eligibility Criteria
Inclusion Criteria
- Cytological or histological confirmation of locally advanced/metastatic or recurrent epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer or endometrial cancer; OR, cytological or histological confirmation of locally advanced /metastatic Her2 non-overexpressing breast cancer
- Eighteen years of age or above
- Candidates for chemotherapy
- Able to understand and sign an informed consent (or have a legal representative who is able to do so)
- Measurable disease according to RECIST v1.1
- ECOG Performance Score (PS) of ≤ 2
- Willing to abstain from sexual intercourse or to use an effective form of contraception during the study and for 90 days following the last dose of MM-121
Exclusion Criteria
- Prior radiation therapy to >25% of bone marrow-bearing areas
- Evidence of any other active malignancy
- Active infection or fever> 38.5°C during screening visits or on the first scheduled day of dosing
- Symptomatic CNS disease
- Known hypersensitivity to any of the components of MM-121 or who have had hypersensitivity reactions to fully human monoclonal antibodies
- Received treatment, within 30 days prior to the first scheduled day of dosing, with any investigational agents that have not received regulatory approval for any indication or disease state
- Pregnant or breast feeding
Data sourced from ClinicalTrials.gov (NCT01209195). 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.