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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


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Epithelial Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival

Outcome Time Frame:

38 months

Safety Issue:

No

Principal Investigator

Victor Moyo, MD

Investigator Role:

Study Director

Investigator Affiliation:

Merrimack Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

MM-121-04-02-08 (ARD11586)

NCT ID:

NCT01447706

Start Date:

October 2011

Completion Date:

April 2015

Related Keywords:

  • Epithelial Ovarian Cancer
  • Fallopian Tube Cancer
  • Peritoneal Cancer
  • Ovarian Cancer
  • Platinum-resistant
  • Platinum-refractory
  • Fallopian tube cancer
  • Peritoneal Cancer
  • Paclitaxel
  • ErbB3
  • Phase II
  • locally advanced/metastatic or recurrent
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location

Comprehensive Blood and Cancer CenterBakersfield, California  93309
Wilshire Oncology Medical GroupGlendora, California  91741
Chattanooga GYN OncologyChattanooga, Tennessee  37403
Carolinas Medical Center/Blumenthal Cancer CenterCharlotte, North Carolina  28203
North County OncologyOceanside, California  92056
Central Coast Medical OncologySanta Maria, California  93454
Indiana University Simon Cancer CenterIndianapolis, Indiana  46202
Pinnacle OncologyScottsdale, Arizona  85258
Arizona Center for Cancer CareGlendale, Arizona  85306
ProMedica Health System, Inc.Toledo, Ohio  43606