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

Primary Purpose

Epithelial Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MM-121
Paclitaxel
Sponsored by
Merrimack Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epithelial Ovarian Cancer focused on measuring Ovarian Cancer, Platinum-resistant, Platinum-refractory, Fallopian tube cancer, Peritoneal Cancer, Paclitaxel, ErbB3, Phase II, locally advanced/metastatic or recurrent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Arizona Center for Cancer Care
  • Pinnacle Oncology
  • Comprehensive Blood and Cancer Center
  • Wilshire Oncology Medical Group
  • North County Oncology
  • Central Coast Medical Oncology
  • Indiana University Simon Cancer Center
  • Carolinas Medical Center/Blumenthal Cancer Center
  • ProMedica Health System, Inc.
  • Chattanooga GYN Oncology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Paclitaxel

MM-121 (SAR256212) + Paclitaxel

Arm Description

Standard dosing paclitaxel: 80 mg/m2 QW intravenously)

administered intravenously at 40 mg/kg loading dose on Cycle 1, Week 1 followed by 20 mg/kg QW for all subsequent doses

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Overall Survival
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.

Full Information

First Posted
October 3, 2011
Last Updated
April 11, 2016
Sponsor
Merrimack Pharmaceuticals
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT01447706
Brief Title
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

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merrimack Pharmaceuticals
Collaborators
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
223 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paclitaxel
Arm Type
Active Comparator
Arm Description
Standard dosing paclitaxel: 80 mg/m2 QW intravenously)
Arm Title
MM-121 (SAR256212) + Paclitaxel
Arm Type
Experimental
Arm Description
administered intravenously at 40 mg/kg loading dose on Cycle 1, Week 1 followed by 20 mg/kg QW for all subsequent doses
Intervention Type
Drug
Intervention Name(s)
MM-121
Other Intervention Name(s)
SAR256212
Intervention Description
MM-121 (SAR256212) (IV)
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Standard dosing Paclitaxel (IV)
Primary Outcome Measure Information:
Title
Progression Free Survival
Description
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 Frame
Time from first dose to date of progression, the longest time frame of 3.9 years
Secondary Outcome Measure Information:
Title
Overall Survival
Description
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.
Time Frame
Time from first dose to date of death, with a median of approximately 13 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victor Moyo, MD
Organizational Affiliation
Merrimack Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Center for Cancer Care
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Pinnacle Oncology
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Comprehensive Blood and Cancer Center
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Wilshire Oncology Medical Group
City
Corona
State/Province
California
ZIP/Postal Code
92879
Country
United States
Facility Name
North County Oncology
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Central Coast Medical Oncology
City
Santa Maria
State/Province
California
ZIP/Postal Code
93454
Country
United States
Facility Name
Indiana University Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Carolinas Medical Center/Blumenthal Cancer Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
ProMedica Health System, Inc.
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
Chattanooga GYN Oncology
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27998236
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.
Results Reference
derived

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

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