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

Merrimack Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Epithelial Ovarian Cancer; Peritoneal Cancer; Fallopian Tube Cancer

Treatments: Drug: Paclitaxel; Drug: MM-121

Study type: Interventional

Funder types: Industry

Identifiers

NCT01447706

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

Details and patient eligibility

About

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

Full 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.

Enrollment: 223 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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223 participants in 2 patient groups

Paclitaxel

Active Comparator group

Description:

Standard dosing paclitaxel: 80 mg/m2 QW intravenously)

Treatment:

Drug: Paclitaxel

MM-121 (SAR256212) + Paclitaxel

Experimental group

Description:

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

Treatment:

Drug: MM-121

Drug: Paclitaxel