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

Merrimack Pharmaceuticals223 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

223

Conditions

Epithelial Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer

Interventions

MM-121DRUG

MM-121 (SAR256212) (IV)

PaclitaxelDRUG

Standard dosing Paclitaxel (IV)

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (10)

Arizona Center for Cancer Care

Glendale, Arizona, United States

Pinnacle Oncology

Scottsdale, Arizona, United States

Comprehensive Blood and Cancer Center

Bakersfield, California, United States

Outcomes

Primary Outcomes

Progression Free Survival

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).

Time frame: Time from first dose to date of progression, the longest time frame of 3.9 years

Secondary Outcomes

Overall Survival

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.

Time frame: Time from first dose to date of death, with a median of approximately 13 months

Data from ClinicalTrials.gov

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