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

NCT ID: NCT00994123

Last Updated: 2016-08-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2015-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Carcinoma, Non-Small-Cell Lung

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Phase 1: Dose-Escalation

Escalating doses of MM-121 (QOW IV) and erlotinib (daily PO)

Group Type EXPERIMENTAL

MM-121

Intervention Type DRUG

MM-121 (SAR256212) = intravenous solution

Erlotinib

Intervention Type DRUG

erlotinib = daily oral tablet

Phase 2: Control

Erlotinib (daily)

Group Type ACTIVE_COMPARATOR

Erlotinib

Intervention Type DRUG

erlotinib = daily oral tablet

Phase 2: Treatment

MM-121 (QOW IV) and erlotinib (daily PO)

Group Type EXPERIMENTAL

MM-121

Intervention Type DRUG

MM-121 (SAR256212) = intravenous solution

Erlotinib

Intervention Type DRUG

erlotinib = daily oral tablet

Interventions

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MM-121

MM-121 (SAR256212) = intravenous solution

Intervention Type DRUG

Erlotinib

erlotinib = daily oral tablet

Intervention Type DRUG

Other Intervention Names

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SAR256212 Tarceva

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merrimack Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Victor Moyo, MD

Role: STUDY_DIRECTOR

Merrimack Pharmaceuticals

Locations

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Birmingham, Alabama, United States

Site Status

Tucson, Arizona, United States

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Loma Linda, California, United States

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Sacramento, California, United States

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San Francisco, California, United States

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Aurora, Colorado, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Lafayette, Indiana, United States

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Boston, Massachusetts, United States

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St Louis, Missouri, United States

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Buffalo, New York, United States

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New York, New York, United States

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Cincinnati, Ohio, United States

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Portland, Oregon, United States

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Pittsburgh, Pennsylvania, United States

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Charleston, South Carolina, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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Edmonton, Alberta, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Heidelberg, Mannheim, Germany

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Bad Berka, , Germany

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Frankfurt, , Germany

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Heidelberg, , Germany

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Lungenklinik, , Germany

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Ulm, , Germany

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Seoul, Gangnam-gu, South Korea

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Seoul, Seodaemun-gu, South Korea

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Barcelona, , Spain

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Madrid, , Spain

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Málaga, , Spain

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Guishan, Taoyuan County, Taiwan

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Taichung, , Taiwan

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Taichung, , Taiwan

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Tainan City, , Taiwan

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Taipei, , Taiwan

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Countries

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United States Canada Germany South Korea Spain Taiwan

Other Identifiers

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MM-121-01-101

Identifier Type: -

Identifier Source: org_study_id

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