- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00994123
A Study of MM-121 Combination Therapy in Patients With Advanced Non-Small Cell Lung Cancer
A Phase 1-2 Trial of MM-121 in Combination With Erlotinib in Three Groups of Patients With Non-Small Cell Lung Cancer
Study Overview
Status
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
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Alberta
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Edmonton, Alberta, Canada
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Ontario
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Toronto, Ontario, Canada, M5G2M9
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Quebec
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Montreal, Quebec, Canada
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Bad Berka, Germany, 99437
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Frankfurt, Germany, 60488
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Heidelberg, Germany, 69126
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Lungenklinik, Germany
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Ulm, Germany, 89081
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Mannheim
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Heidelberg, Mannheim, Germany, 68167
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Gangnam-gu
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Seoul, Gangnam-gu, Korea, Republic of, 135-710
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Seodaemun-gu
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Seoul, Seodaemun-gu, Korea, Republic of, 120-752
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Barcelona, Spain, 08035
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Madrid, Spain
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Malaga, Spain, 29010
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Taichung, Taiwan
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Taichung, Taiwan, 40705
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Tainan City, Taiwan, 70146
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Taipei, Taiwan, 100
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Taoyuan County
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Guishan, Taoyuan County, Taiwan, 33305
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Alabama
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Birmingham, Alabama, United States, 35294
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Arizona
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Tucson, Arizona, United States, 85715
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California
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Loma Linda, California, United States, 92354
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Sacramento, California, United States, 95817
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San Francisco, California, United States, 94115
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Colorado
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Aurora, Colorado, United States, 80045
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Florida
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Tampa, Florida, United States, 33612
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Georgia
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Atlanta, Georgia, United States, 30322
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Indiana
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Lafayette, Indiana, United States, 47905
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Massachusetts
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Boston, Massachusetts, United States, 02114
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Missouri
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St. Louis, Missouri, United States, 63110
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New York
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Buffalo, New York, United States, 14263
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New York, New York, United States, 10065
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Ohio
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Cincinnati, Ohio, United States, 45267
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Oregon
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Portland, Oregon, United States, 97239
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15232
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South Carolina
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Charleston, South Carolina, United States, 29425
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Tennessee
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Nashville, Tennessee, United States, 37232
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Texas
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Dallas, Texas, United States, 75390
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
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Experimental: Phase 1: Dose-Escalation
Escalating doses of MM-121 (QOW IV) and erlotinib (daily PO)
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MM-121 (SAR256212) = intravenous solution
Other Names:
erlotinib = daily oral tablet
Other Names:
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Active Comparator: Phase 2: Control
Erlotinib (daily)
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erlotinib = daily oral tablet
Other Names:
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Experimental: Phase 2: Treatment
MM-121 (QOW IV) and erlotinib (daily PO)
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MM-121 (SAR256212) = intravenous solution
Other Names:
erlotinib = daily oral tablet
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
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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.
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From date of first dose to 30 days after termination, the longest 175 weeks
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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
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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
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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
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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).
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Time from first dose to date of progression, with a median of 8.1 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Victor Moyo, MD, Merrimack Pharmaceuticals
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Erlotinib Hydrochloride
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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