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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2014-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MM-121 + Paclitaxel

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

Group Type EXPERIMENTAL

MM-121

Intervention Type DRUG

increasing doses of MM-121 IV QW

Paclitaxel

Intervention Type DRUG

Paclitaxel - 80 mg/m2 IV QW

Interventions

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MM-121

increasing doses of MM-121 IV QW

Intervention Type DRUG

Paclitaxel

Paclitaxel - 80 mg/m2 IV QW

Intervention Type DRUG

Other Intervention Names

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Seribantumab, SAR256212 Taxol

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No