A Study of MM-121 With Paclitaxel in Platinum Resistant/ Refractory Advanced Ovarian Cancers
NCT ID: NCT01447706
Last Updated: 2016-05-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
223 participants
INTERVENTIONAL
2011-10-31
2015-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Paclitaxel
Standard dosing paclitaxel: 80 mg/m2 QW intravenously)
Paclitaxel
Standard dosing Paclitaxel (IV)
MM-121 (SAR256212) + Paclitaxel
administered intravenously at 40 mg/kg loading dose on Cycle 1, Week 1 followed by 20 mg/kg QW for all subsequent doses
MM-121
MM-121 (SAR256212) (IV)
Paclitaxel
Standard dosing Paclitaxel (IV)
Interventions
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MM-121
MM-121 (SAR256212) (IV)
Paclitaxel
Standard dosing Paclitaxel (IV)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* History of severe allergic reactions to paclitaxel or other drugs formulated in Cremophor®EL
18 Years
FEMALE
No
Sponsors
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Sanofi
INDUSTRY
Merrimack Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Victor Moyo, MD
Role: STUDY_DIRECTOR
Merrimack Pharmaceuticals
Locations
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Arizona Center for Cancer Care
Glendale, Arizona, United States
Pinnacle Oncology
Scottsdale, Arizona, United States
Comprehensive Blood and Cancer Center
Bakersfield, California, United States
Wilshire Oncology Medical Group
Corona, California, United States
North County Oncology
Oceanside, California, United States
Central Coast Medical Oncology
Santa Maria, California, United States
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States
Carolinas Medical Center/Blumenthal Cancer Center
Charlotte, North Carolina, United States
ProMedica Health System, Inc.
Toledo, Ohio, United States
Chattanooga GYN Oncology
Chattanooga, Tennessee, United States
Countries
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References
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Liu JF, Ray-Coquard I, Selle F, Poveda AM, Cibula D, Hirte H, Hilpert F, Raspagliesi F, Gladieff L, Harter P, Siena S, Del Campo JM, Tabah-Fisch I, Pearlberg J, Moyo V, Riahi K, Nering R, Kubasek W, Adiwijaya B, Czibere A, Naumann RW, Coleman RL, Vergote I, MacBeath G, Pujade-Lauraine E. Randomized Phase II Trial of Seribantumab in Combination With Paclitaxel in Patients With Advanced Platinum-Resistant or -Refractory Ovarian Cancer. J Clin Oncol. 2016 Dec 20;34(36):4345-4353. doi: 10.1200/JCO.2016.67.1891. Epub 2016 Oct 23.
Other Identifiers
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MM-121-04-02-08 (ARD11586)
Identifier Type: -
Identifier Source: org_study_id
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