Overview

This trial is active, not recruiting.

Conditions epithelial ovarian cancer, fallopian tube cancer, peritoneal cancer
Treatments mm-121 (sar256212) + paclitaxel, paclitaxel
Phase phase 2
Sponsor Merrimack Pharmaceuticals
Collaborator Sanofi
Start date October 2011
End date December 2014
Trial size 210 participants
Trial identifier NCT01447706, MM-121-04-02-08 (ARD11586)

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
paclitaxel
Standard dosing Paclitaxel (IV)
(Experimental)
mm-121 (sar256212) + paclitaxel
MM-121 (SAR256212) (IV) plus standard dosing Paclitaxel (IV)

Primary Outcomes

Measure
Progression Free Survival
time frame: 38 months

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title A Phase II Randomized Open Label Study of MM-121 in Combination With Paclitaxel Versus Paclitaxel Alone in Patients With Platinum Resistant/ Refractory Advanced Ovarian Cancers
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2013.
Information provided to ClinicalTrials.gov by Merrimack Pharmaceuticals.