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Completed

NCT Number: NCT01447706

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

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

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Key information

Conditions

Epithelial Ovarian Cancer Adnexal Diseases Carcinoma Carcinoma, Ovarian Epithelial Disease Attributes Endocrine Gland Neoplasms Endocrine System Diseases Fallopian Tube Cancer Fallopian Tube Diseases Fallopian Tube Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplastic Processes Ovarian Diseases Ovarian Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Peritoneal Cancer Recurrence Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Arizona Center for Cancer Care, Glendale, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MM-121

Drug

MM-121 (SAR256212) (IV)

Other names: SAR256212

paclitaxel

Drug

Standard dosing Paclitaxel (IV)

Primary outcomes

  1. Progression Free Survival

    Time frame: 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 outcomes

  1. Overall Survival

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Merrimack Pharmaceuticals

Industry

Collaborators

  • Sanofi

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2015
First posted
Oct 6, 2011
Registry last updated
May 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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