A Study of MM-121 Combination Therapy in Patients With Advanced Non-Small Cell Lung Cancer

July 12, 2016 updated by: Merrimack Pharmaceuticals

A Phase 1-2 Trial of MM-121 in Combination With Erlotinib in Three Groups of Patients With Non-Small Cell Lung Cancer

A Phase 1-2 study of MM-121 in combination with standard therapy for non-small cell lung cancer (NSCLC).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Phase 1: Patients with Non-Small Cell Lung Cancer (NSCLC) may be enrolled to evaluate the safety, tolerability and recommended Phase 2 dose of MM-121 in combination with standard therapy.

Phase 2: Patients with Non-Small Cell Lung Cancer (NSCLC) may be enrolled to estimate the progression-free survival of the MM-121 + standard therapy.

Study Type

Interventional

Enrollment (Actual)

162

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G2M9
    • Quebec
      • Montreal, Quebec, Canada
  • Germany
      • Bad Berka, Germany, 99437
      • Frankfurt, Germany, 60488
      • Heidelberg, Germany, 69126
      • Lungenklinik, Germany
      • Ulm, Germany, 89081
    • Mannheim
      • Heidelberg, Mannheim, Germany, 68167
  • Korea, Republic of
    • Gangnam-gu
      • Seoul, Gangnam-gu, Korea, Republic of, 135-710
    • Seodaemun-gu
      • Seoul, Seodaemun-gu, Korea, Republic of, 120-752
  • Spain
      • Barcelona, Spain, 08035
      • Madrid, Spain
      • Malaga, Spain, 29010
  • Taiwan
      • Taichung, Taiwan
      • Taichung, Taiwan, 40705
      • Tainan City, Taiwan, 70146
      • Taipei, Taiwan, 100
    • Taoyuan County
      • Guishan, Taoyuan County, Taiwan, 33305
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
    • Arizona
      • Tucson, Arizona, United States, 85715
    • California
      • Loma Linda, California, United States, 92354
      • Sacramento, California, United States, 95817
      • San Francisco, California, United States, 94115
    • Colorado
      • Aurora, Colorado, United States, 80045
    • Florida
      • Tampa, Florida, United States, 33612
    • Georgia
      • Atlanta, Georgia, United States, 30322
    • Indiana
      • Lafayette, Indiana, United States, 47905
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
    • Missouri
      • St. Louis, Missouri, United States, 63110
    • New York
      • Buffalo, New York, United States, 14263
      • New York, New York, United States, 10065
    • Ohio
      • Cincinnati, Ohio, United States, 45267
    • Oregon
      • Portland, Oregon, United States, 97239
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
    • South Carolina
      • Charleston, South Carolina, United States, 29425
    • Tennessee
      • Nashville, Tennessee, United States, 37232
    • Texas
      • Dallas, Texas, United States, 75390

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with locally advanced or metastatic non-small cell lung cancer.
  • Patients must be >/= 18 years of age.
  • Patients must have adequate Performance Status (PS) as measured by ECOG and adequate end organ function.

Exclusion Criteria:

  • Patients with a recent history (within 5 years) of another malignancy.
  • Patients who are pregnant or nursing.
  • Patients with clinically significant heart failure.
  • Patients with clinically significant eye or gastrointestinal abnormalities.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase 1: Dose-Escalation
Escalating doses of MM-121 (QOW IV) and erlotinib (daily PO)
Drug: MM-121
MM-121 (SAR256212) = intravenous solution
Other Names:
  • SAR256212
Drug: Erlotinib
erlotinib = daily oral tablet
Other Names:
  • Tarceva
Active Comparator: Phase 2: Control
Erlotinib (daily)
Drug: Erlotinib
erlotinib = daily oral tablet
Other Names:
  • Tarceva
Experimental: Phase 2: Treatment
MM-121 (QOW IV) and erlotinib (daily PO)
Drug: MM-121
MM-121 (SAR256212) = intravenous solution
Other Names:
  • SAR256212
Drug: Erlotinib
erlotinib = daily oral tablet
Other Names:
  • Tarceva

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1: To Determine the Recommended Phase 2 Dose of the MM-121 + Erlotinib Combination Based Upon Either the Maximum Tolerated Dose (MTD) or the Maximum Feasible Dose of the Combination in Patients With NSCLC.
Time Frame: From date of first dose to 30 days after termination, the longest 175 weeks
To establish the safety of escalating doses of MM-121 in combination with erlotinib in order to determine the recommended phase 2 dose of the combination for the second part of the study. Dose-escalation conducted using standard 3+3 model to determine maximum tolerated dose. Reports of Dose-Limiting Toxicities (DLTs) were assessed to determine the MTD.
From date of first dose to 30 days after termination, the longest 175 weeks
Phase 1: Determine the Maximum Tolerated Dose Dependent on Reports of Dose-limiting Toxicities
Time Frame: From date of first dose to 30 days after termination, the longest 175 weeks

Using a 3+3 dose escalation model, the maximum tolerated dose was determined by assessing dose-limiting toxicities in each cohort. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in the expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs.

The determined MTD was used as the recommended Phase 2 dose.
From date of first dose to 30 days after termination, the longest 175 weeks
Phase 2: Progression-free Survival of the MM-121 + Erlotinib Combination
Time Frame: Time from first dose to date of progression, with a median of 8.1 weeks
This was a time-to-event measure using Progression-Free Survival (PFS) comparing MM-121 + erlotinib vs.erlotinib alone. 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 weeks 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 from first dose to date of progression, with a median of 8.1 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merrimack Pharmaceuticals

Investigators

  • Study Director: Victor Moyo, MD, Merrimack Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

October 13, 2009

First Submitted That Met QC Criteria

October 13, 2009

First Posted (Estimate)

October 14, 2009

Study Record Updates

Last Update Posted (Estimate)

August 22, 2016

Last Update Submitted That Met QC Criteria

July 12, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MM-121-01-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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