A Study of MM-121 With Paclitaxel in Platinum Resistant/ Refractory Advanced Ovarian Cancers

NCT ID: NCT01447706

Last Updated: 2016-05-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

223 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2015-06-30

Brief Summary

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To determine whether the combination of MM-121 plus paclitaxel is more effective than paclitaxel alone

Detailed Description

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This is a multicenter, open-label, randomized, Phase II study of MM-121 in patients with platinum resistant or refractory recurrent/advanced ovarian cancers. Up to 210 patients will be randomized (2:1) to receive MM-121 plus paclitaxel or paclitaxel alone.

Conditions

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Epithelial Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Paclitaxel

Standard dosing paclitaxel: 80 mg/m2 QW intravenously)

Group Type ACTIVE_COMPARATOR

Paclitaxel

Intervention Type DRUG

Standard dosing Paclitaxel (IV)

MM-121 (SAR256212) + Paclitaxel

administered intravenously at 40 mg/kg loading dose on Cycle 1, Week 1 followed by 20 mg/kg QW for all subsequent doses

Group Type EXPERIMENTAL

MM-121

Intervention Type DRUG

MM-121 (SAR256212) (IV)

Paclitaxel

Intervention Type DRUG

Standard dosing Paclitaxel (IV)

Interventions

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MM-121

MM-121 (SAR256212) (IV)

Intervention Type DRUG

Paclitaxel

Standard dosing Paclitaxel (IV)

Intervention Type DRUG

Other Intervention Names

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SAR256212

Eligibility Criteria

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Inclusion Criteria

* Locally advanced/metastatic or recurrent epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer
* Received at least one prior platinum based chemotherapy regimen
* Platinum-resistant or refractory
* Eligible for weekly paclitaxel
* Adequate liver and kidney function
* 18 years of age or above

Exclusion Criteria

* Evidence of any other active malignancy
* History of severe allergic reactions to paclitaxel or other drugs formulated in Cremophor®EL
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role collaborator

Merrimack Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Victor Moyo, MD

Role: STUDY_DIRECTOR

Merrimack Pharmaceuticals

Locations

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Arizona Center for Cancer Care

Glendale, Arizona, United States

Site Status

Pinnacle Oncology

Scottsdale, Arizona, United States

Site Status

Comprehensive Blood and Cancer Center

Bakersfield, California, United States

Site Status

Wilshire Oncology Medical Group

Corona, California, United States

Site Status

North County Oncology

Oceanside, California, United States

Site Status

Central Coast Medical Oncology

Santa Maria, California, United States

Site Status

Indiana University Simon Cancer Center

Indianapolis, Indiana, United States

Site Status

Carolinas Medical Center/Blumenthal Cancer Center

Charlotte, North Carolina, United States

Site Status

ProMedica Health System, Inc.

Toledo, Ohio, United States

Site Status

Chattanooga GYN Oncology

Chattanooga, Tennessee, United States

Site Status

Countries

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United States

References

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Liu JF, Ray-Coquard I, Selle F, Poveda AM, Cibula D, Hirte H, Hilpert F, Raspagliesi F, Gladieff L, Harter P, Siena S, Del Campo JM, Tabah-Fisch I, Pearlberg J, Moyo V, Riahi K, Nering R, Kubasek W, Adiwijaya B, Czibere A, Naumann RW, Coleman RL, Vergote I, MacBeath G, Pujade-Lauraine E. Randomized Phase II Trial of Seribantumab in Combination With Paclitaxel in Patients With Advanced Platinum-Resistant or -Refractory Ovarian Cancer. J Clin Oncol. 2016 Dec 20;34(36):4345-4353. doi: 10.1200/JCO.2016.67.1891. Epub 2016 Oct 23.

Reference Type DERIVED
PMID: 27998236 (View on PubMed)

Other Identifiers

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MM-121-04-02-08 (ARD11586)

Identifier Type: -

Identifier Source: org_study_id

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