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
1 other identifier
interventional
162
6 countries
38
Brief Summary
A Phase 1-2 study of MM-121 in combination with standard therapy for non-small cell lung cancer (NSCLC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2010
Longer than P75 for phase_1
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 13, 2009
CompletedFirst Posted
Study publicly available on registry
October 14, 2009
CompletedStudy Start
First participant enrolled
February 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedResults Posted
Study results publicly available
August 22, 2016
CompletedAugust 22, 2016
July 1, 2016
4.8 years
October 13, 2009
February 14, 2016
July 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
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
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
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
Study Arms (3)
Phase 1: Dose-Escalation
EXPERIMENTALEscalating doses of MM-121 (QOW IV) and erlotinib (daily PO)
Phase 2: Control
ACTIVE COMPARATORErlotinib (daily)
Phase 2: Treatment
EXPERIMENTALMM-121 (QOW IV) and erlotinib (daily PO)
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (38)
Unknown Facility
Birmingham, Alabama, 35294, United States
Unknown Facility
Tucson, Arizona, 85715, United States
Unknown Facility
Loma Linda, California, 92354, United States
Unknown Facility
Sacramento, California, 95817, United States
Unknown Facility
San Francisco, California, 94115, United States
Unknown Facility
Aurora, Colorado, 80045, United States
Unknown Facility
Tampa, Florida, 33612, United States
Unknown Facility
Atlanta, Georgia, 30322, United States
Unknown Facility
Lafayette, Indiana, 47905, United States
Unknown Facility
Boston, Massachusetts, 02114, United States
Unknown Facility
St Louis, Missouri, 63110, United States
Unknown Facility
Buffalo, New York, 14263, United States
Unknown Facility
New York, New York, 10065, United States
Unknown Facility
Cincinnati, Ohio, 45267, United States
Unknown Facility
Portland, Oregon, 97239, United States
Unknown Facility
Pittsburgh, Pennsylvania, 15232, United States
Unknown Facility
Charleston, South Carolina, 29425, United States
Unknown Facility
Nashville, Tennessee, 37232, United States
Unknown Facility
Dallas, Texas, 75390, United States
Unknown Facility
Edmonton, Alberta, Canada
Unknown Facility
Toronto, Ontario, M5G2M9, Canada
Unknown Facility
Montreal, Quebec, Canada
Unknown Facility
Heidelberg, Mannheim, 68167, Germany
Unknown Facility
Bad Berka, 99437, Germany
Unknown Facility
Frankfurt, 60488, Germany
Unknown Facility
Heidelberg, 69126, Germany
Unknown Facility
Lungenklinik, Germany
Unknown Facility
Ulm, 89081, Germany
Unknown Facility
Seoul, Gangnam-gu, 135-710, South Korea
Unknown Facility
Seoul, Seodaemun-gu, 120-752, South Korea
Unknown Facility
Barcelona, 08035, Spain
Unknown Facility
Madrid, Spain
Unknown Facility
Málaga, 29010, Spain
Unknown Facility
Guishan, Taoyuan County, 33305, Taiwan
Unknown Facility
Taichung, 40705, Taiwan
Unknown Facility
Taichung, Taiwan
Unknown Facility
Tainan, 70146, Taiwan
Unknown Facility
Taipei, 100, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Manager
- Organization
- Merrimack Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Victor Moyo, MD
Merrimack Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2009
First Posted
October 14, 2009
Study Start
February 1, 2010
Primary Completion
November 1, 2014
Study Completion
June 1, 2015
Last Updated
August 22, 2016
Results First Posted
August 22, 2016
Record last verified: 2016-07