A Study of MM-121 in Combination With Paclitaxel in Patients With Advanced Gynecologic and Breast Cancers

Merrimack Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Locally Advanced/Metastatic or Recurrent Ovarian Cancer, Fallopian Tube Cancer,; Primary Peritoneal Cancer or Endometrial Cancer; Locally Advanced/Metastatic Her2 Non Overexpressing Breast Cancer

Treatments: Drug: MM-121; Drug: Paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT01209195

MM-121-04-01-04

Details and patient eligibility

About

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.

Full description

Successive cohorts of three or more patients were treated at escalating doses until a maximum tolerated dose/recommended phase 1 dose was identified. Once the maximum tolerated dose was identified, an Expansion Cohort was enrolled at that dose to further characterize safety and to explore pharmacodynamic endpoints.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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41 participants in 1 patient group

MM-121 + Paclitaxel

Experimental group

Description:

Escalating doses of MM-121 given IV QW in combination with paclitaxel at standard dose of 80 mg/m2 IV QW

Treatment:

Drug: Paclitaxel

Drug: MM-121