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

Phase 2

Completed

• Conditions: Epithelial Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer
• Interventions: Drug: MM-121; Drug: Paclitaxel

• Registration Number: NCT01447706
• Lead Sponsor: Merrimack Pharmaceuticals

Brief Summary

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

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-03
• Study First Submitted QC: 2011-10-04
• Study First Posted: 2011-10-06
• Primary Completion: 2013-09
• Study Completion: 2015-06
• Results First Submitted: 2016-02-17
• Status Verified: 2016-04
• Results First Submitted QC: 2016-04-11
• Last Update Submitted: 2016-04-11
• Results First Posted: 2016-05-12
• Last Update Posted: 2016-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 223

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

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Exclusion Criteria

• Evidence of any other active malignancy
• History of severe allergic reactions to paclitaxel or other drugs formulated in Cremophor®EL

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MM-121 (SAR256212) + Paclitaxel	MM-121	administered intravenously at 40 mg/kg loading dose on Cycle 1, Week 1 followed by 20 mg/kg QW for all subsequent doses
Paclitaxel	Paclitaxel	Standard dosing paclitaxel: 80 mg/m2 QW intravenously)
MM-121 (SAR256212) + Paclitaxel	Paclitaxel	administered intravenously at 40 mg/kg loading dose on Cycle 1, Week 1 followed by 20 mg/kg QW for all subsequent doses

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	Time from first dose to date of progression, the longest time frame of 3.9 years	To determine whether MM-121 + paclitaxel was more effective than paclitaxel alone in prolonging progression-free survival in advanced ovarian cancers resistant or refractory to platinum agents. PFS was a time to event measure, and progression of disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), "as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions". Progression free survival was defined as the number of months from the date of randomization to the date of death or progression. If neither death nor progression was observed during the study, PFS data was censored at the last non-progressive disease valid tumor assessment unless the patient was discontinued due to symptomatic deterioration. If this occurred, the patient was counted as having progressive disease (PD).

Secondary Outcome Measures

Name	Time	Method
Overall Survival	Time from first dose to date of death, with a median of approximately 13 months	To determine whether MM-121 + paclitaxel is more effective than paclitaxel alone in prolonging overall survival. This was a time-to-event analysis of time from first dose to date of death.

Trial Locations

Locations (10)

Wilshire Oncology Medical Group; 🇺🇸 Corona, California, United States

Pinnacle Oncology; 🇺🇸 Scottsdale, Arizona, United States

ProMedica Health System, Inc.; 🇺🇸 Toledo, Ohio, United States

Comprehensive Blood and Cancer Center; 🇺🇸 Bakersfield, California, United States

Indiana University Simon Cancer Center; 🇺🇸 Indianapolis, Indiana, United States

Chattanooga GYN Oncology; 🇺🇸 Chattanooga, Tennessee, United States

Arizona Center for Cancer Care; 🇺🇸 Glendale, Arizona, United States

North County Oncology; 🇺🇸 Oceanside, California, United States

Carolinas Medical Center/Blumenthal Cancer Center; 🇺🇸 Charlotte, North Carolina, United States

Central Coast Medical Oncology; 🇺🇸 Santa Maria, California, United States