A Study of MM-121 With Paclitaxel in Platinum Resistant/ Refractory Advanced Ovarian Cancers
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
1 other identifier
interventional
223
1 country
10
Brief Summary
To determine whether the combination of MM-121 plus paclitaxel is more effective than paclitaxel alone
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2011
Typical duration for phase_2
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 3, 2011
CompletedFirst Posted
Study publicly available on registry
October 6, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedResults Posted
Study results publicly available
May 12, 2016
CompletedMay 12, 2016
April 1, 2016
1.9 years
October 3, 2011
February 17, 2016
April 11, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 from first dose to date of progression, the longest time frame of 3.9 years
Secondary Outcomes (1)
Overall Survival
Time from first dose to date of death, with a median of approximately 13 months
Study Arms (2)
Paclitaxel
ACTIVE COMPARATORStandard dosing paclitaxel: 80 mg/m2 QW intravenously)
MM-121 (SAR256212) + Paclitaxel
EXPERIMENTALadministered intravenously at 40 mg/kg loading dose on Cycle 1, Week 1 followed by 20 mg/kg QW for all subsequent doses
Interventions
Eligibility Criteria
You may qualify if:
- 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
- years of age or above
You may not qualify if:
- Evidence of any other active malignancy
- History of severe allergic reactions to paclitaxel or other drugs formulated in Cremophor®EL
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Merrimack Pharmaceuticalslead
- Sanoficollaborator
Study Sites (10)
Arizona Center for Cancer Care
Glendale, Arizona, 85306, United States
Pinnacle Oncology
Scottsdale, Arizona, 85258, United States
Comprehensive Blood and Cancer Center
Bakersfield, California, 93309, United States
Wilshire Oncology Medical Group
Corona, California, 92879, United States
North County Oncology
Oceanside, California, 92056, United States
Central Coast Medical Oncology
Santa Maria, California, 93454, United States
Indiana University Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Carolinas Medical Center/Blumenthal Cancer Center
Charlotte, North Carolina, 28203, United States
ProMedica Health System, Inc.
Toledo, Ohio, 43606, United States
Chattanooga GYN Oncology
Chattanooga, Tennessee, 37403, United States
Related Publications (1)
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.
PMID: 27998236DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Manager
- Organization
- Merrimack Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Victor Moyo, MD
Merrimack Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2011
First Posted
October 6, 2011
Study Start
October 1, 2011
Primary Completion
September 1, 2013
Study Completion
June 1, 2015
Last Updated
May 12, 2016
Results First Posted
May 12, 2016
Record last verified: 2016-04