Clinical trial NCT01447706: A Study of MM-121 With Paclitaxel in Platinum Resistant/ Refractory Advanced Ovarian Cancers
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Epithelial Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Cancer
Keywords: Ovarian Cancer
Platinum-resistant
Platinum-refractory
Fallopian tube cancer
Peritoneal Cancer
Paclitaxel
ErbB3
Phase II
locally advanced/metastatic or recurrent
Lead sponsor: Merrimack Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2011-10-06
Enrollment: 223
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression Free Survival
timeFrame: Time from first dose to date of progression, the longest time frame of 3.9 years
Secondary outcomes:
measure: Overall Survival
timeFrame: Time from first dose to date of death, with a median of approximately 13 months
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Arizona Center for Cancer Care
state: Arizona
city: Scottsdale
country: United States
facility: Pinnacle Oncology
state: Arizona
city: Bakersfield
country: United States
facility: Comprehensive Blood and Cancer Center
state: California
city: Corona
country: United States
facility: Wilshire Oncology Medical Group
state: California
city: Oceanside
country: United States
facility: North County Oncology
state: California
city: Santa Maria
country: United States
facility: Central Coast Medical Oncology
state: California
city: Indianapolis
country: United States
facility: Indiana University Simon Cancer Center
state: Indiana
city: Charlotte
country: United States
facility: Carolinas Medical Center/Blumenthal Cancer Center
state: North Carolina
city: Toledo
country: United States
facility: ProMedica Health System, Inc.
state: Ohio
city: Chattanooga
country: United States
facility: Chattanooga GYN Oncology
state: Tennessee
Study officials:
affiliation: Merrimack Pharmaceuticals
name: Victor Moyo, MD
role: STUDY_DIRECTOR
References:
citation: 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.