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Miami, Florida

  • Pancreatic Cancer

Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

MM-141-07-02-02


NCT ID:

NCT02399137


Secondary ID:


Study Acronym:

CARRIE


Brief Title:

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


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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Merrimack Pharmaceuticals


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

88


Enrollment Type:

Actual


Overall Contact Information

Official Name:MM-141 Medical Director, MD
Study Director
Merrimack Pharmaceuticals

Study Dates

Start Date:May 2015
Completion Date:August 2018
Completion Type:Actual
Primary Completion Date:August 2018
Primary Completion Type:Actual
Verification Date:September 2018
Last Changed Date:September 17, 2018
First Received Date:March 19, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Duration of Response according to RECIST v1.1
Time Frame:Approximately 2 years
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Objective Response Rate according to RECIST v1.1
Time Frame:Approximately 2 years
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Overall Survival
Time Frame:Approximately 2.5 years
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Progression Free Survival
Time Frame:Approximately 2 years
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:MM-141
Arm Name:Arm A (Experimental Arm)
Intervention Type:Drug
Name:Placebo
Arm Name:Arm B (Comparator Arm)
Intervention Type:Drug
Name:Gemcitabine
Arm Name:Arm A (Experimental Arm)
Other Name:Gemzar
Intervention Type:Drug
Name:Nab-Paclitaxel
Arm Name:Arm A (Experimental Arm)
Other Name:Abraxane

Study Arms

Study Arm Type:Experimental
Arm Name:Arm A (Experimental Arm)
Description:MM-141 in combination with nab-paclitaxel and gemcitabine
Study Arm Type:Active Comparator
Arm Name:Arm B (Comparator Arm)
Description:Placebo in combination with nab-paclitaxel and gemcitabine
Study Arm Type:No Intervention
Arm Name:Observational Group

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Merrimack Pharmaceuticals

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 07, 2020

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