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A Phase 2 Study of MM-141 Plus Nab-paclitaxel and Gemcitabine in Front-line Metastatic Pancreatic Cancer (CARRIE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02399137
Recruitment Status : Completed
First Posted : March 26, 2015
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
Merrimack Pharmaceuticals

Study Description
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Brief Summary:
The purpose of this study is to determine whether the combination of MM-141 plus nab-paclitaxel and gemcitabine is more effective than nab-paclitaxel and gemcitabine alone based on Progression Free Survival (PFS) in front-line metastatic pancreatic cancer patients with high serum levels of free IGF-1.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: MM-141 Drug: Placebo Drug: Gemcitabine Drug: Nab-Paclitaxel Phase 2

Detailed Description:
This is a randomized, double-blind, placebo-controlled Phase 2 study of MM-141 plus nab-paclitaxel and gemcitabine or placebo plus nab-paclitaxel and gemcitabine in front-line metastatic pancreatic cancer. All patients will be initially screened for free IGF-1 status. Eligible patients with high free IGF-1 will be randomized to receive MM-141 plus nab-paclitaxel and gemcitabine or placebo plus nab-paclitaxel and gemcitabine and patients. Patients with low free IGF-1 or patients who have high free IGF-1 but are not otherwise eligible will be followed in an observational group.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Phase 2 Study of MM-141 Plus Nab-paclitaxel and Gemcitabine Versus Nab-paclitaxel and Gemcitabine in Front-line Metastatic Pancreatic Cancer
Study Start Date : May 2015
Actual Primary Completion Date : August 2018
Actual Study Completion Date : August 2018

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A (Experimental Arm)
MM-141 in combination with nab-paclitaxel and gemcitabine
 Drug: MM-141
Drug: Gemcitabine
Other Name: Gemzar

Drug: Nab-Paclitaxel
Other Name: Abraxane
Active Comparator: Arm B (Comparator Arm)
Placebo in combination with nab-paclitaxel and gemcitabine
 Drug: Placebo
Drug: Gemcitabine
Other Name: Gemzar

Drug: Nab-Paclitaxel
Other Name: Abraxane
No Intervention: Observational Group


Outcome Measures
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Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: Approximately 2 years ]

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: Approximately 2.5 years ]
  2. Objective Response Rate according to RECIST v1.1 [ Time Frame: Approximately 2 years ]
  3. Duration of Response according to RECIST v1.1 [ Time Frame: Approximately 2 years ]
  4. Rate of adverse events reported with the combination of MM-141 with nab-paclitaxel and gemcitabine versus the comparator arm [ Time Frame: Approximately 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Metastatic adenocarcinoma of the pancreas. Patients with islet cell neoplasms are not eligible.
  • Patient must have received no prior radiotherapy, surgery, chemotherapy, or investigational therapy for the treatment of metastatic disease.
  • Blood sample sent for free IGF-1 testing
  • ECOG performance status (PS) of 0 or 1

Exclusion Criteria:

  • Patients who only present with localized disease
  • Patients with CNS malignancies (primary or metastatic)
  • Clinically significant cardiac disease
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02399137


Locations
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Sponsors and Collaborators
Merrimack Pharmaceuticals
Investigators
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Study Director: MM-141 Medical Director, MD Merrimack Pharmaceuticals
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02399137    
Other Study ID Numbers: MM-141-07-02-02
First Posted: March 26, 2015    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018
Keywords provided by Merrimack Pharmaceuticals:
Pancreatic Cancer
Front-line Pancreatic Cancer
Metastatic Pancreatic Cancer
Gemcitabine
 Nab-paclitaxel
Abraxane
Free IGF-1
Heregulin
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Paclitaxel
 Gemcitabine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites