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

This study is currently recruiting participants.
Verified February 2013 by Merrimack Pharmaceuticals
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00994123
First received: October 13, 2009
Last updated: February 21, 2013
Last verified: February 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
 Drug: MM-121 (SAR256212) + erlotinib
Drug: Erlotinib
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1-2 Trial of MM-121 in Combination With Erlotinib in Three Groups of Patients With Non-Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Merrimack Pharmaceuticals:

Primary Outcome Measures:
  • 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: June 2011 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Phase 2: To estimate the progression-free survival of the MM-121 + erlotinib combination in patients with NSCLC. [ Time Frame: December 2012 ] [ Designated as safety issue: No ]

Estimated Enrollment: 260
Study Start Date: February 2010
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MM-121+erlotinib Drug: MM-121 (SAR256212) + erlotinib
MM-121 (SAR256212) = intravenous solution erlotinib = daily oral tablet
Other Name: MM-121 (SAR256212) + Tarceva
Active Comparator: Erlotinib (Tarceva) Drug: Erlotinib
erlotinib = daily oral tablet
Other Name: Tarceva

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00994123

  Hide Study Locations
Locations
United States, Alabama
Recruiting
Birmingham, Alabama, United States, 35294
Contact: Mary Jerome     205-934-5092     msjerome@uab.edu    
United States, Arizona
Recruiting
Tucson, Arizona, United States, 85715
Contact: Patricia M. Plezia, Pharm.D.     520-290-2510     Admin@ACRCResearch.com    
United States, California
Recruiting
Loma Linda, California, United States, 92354
Contact: Candace Turner-Santacroce     909-558-3344 ext 33377     cturner@llu.edu    
Recruiting
Sacramento, California, United States, 95817
Contact: Cinda Lyon     916-734-0195     cinda.lyon@ucdmc.ucdavis.edu    
Recruiting
San Francisco, California, United States, 94115
Contact: Carl Formaker     415-353-7912     carl.formaker@cc.ucs.edu    
United States, Colorado
Recruiting
Aurora, Colorado, United States, 80045
Contact: Krista Bradley     720-848-0676     krista.bradley@ucdenver.edu    
United States, Florida
Recruiting
Tampa, Florida, United States, 33612
Contact: Aaron Becker     813-745-4679     aaron.becker@moffitt.org    
United States, Georgia
Recruiting
Atlanta, Georgia, United States, 30322
Contact: Jacene Myrie     404-778-4576     jacene.myrie@emory.edu    
United States, Indiana
Recruiting
Lafayette, Indiana, United States, 47905
Contact: Danielle Morris     765-446-5111 ext 19107     dmorris@horizonbioadvance.com    
United States, Massachusetts
Recruiting
Boston, Massachusetts, United States, 02114
Contact: Patricia Ostler McCarthy, RN     617-724-7829     postler@partners.org    
United States, Missouri
Recruiting
St. Louis, Missouri, United States, 63110
Contact: Kristi Williams     314-362-6963        
United States, New York
Recruiting
Buffalo, New York, United States, 14263
Contact: Janet Pantano     716-845-8647     Janet.Pantano@roswellpark.org    
Recruiting
New York, New York, United States, 10065
Contact: Katherine Rodriguez     646-888-4376     rodrigk3@mskcc.org    
United States, Ohio
Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Cathy Gabis     513-584-1160     gabiscm@ucmail.uc.edu    
United States, Oregon
Recruiting
Portland, Oregon, United States, 97239
Contact: Andrea Burt     503-494-5601     burtan@ohsu.edu    
United States, Pennsylvania
Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Jeanine Andrews     412-623-8968     andrewsj@upmc.edu    
United States, South Carolina
Recruiting
Charleston, South Carolina, United States, 29425
Contact: Jennifer Philip     843-7926429     philipj@musc.edu    
United States, Tennessee
Recruiting
Nashville, Tennessee, United States, 37232
Contact: Clinical Trials Information Program     800-811-8480        
United States, Texas
Recruiting
Dallas, Texas, United States, 75390
Contact: Laurin Loudat     214-648-1688     laurin.loudat@utsouthwestern.edu    
Canada, Alberta
Recruiting
Edmonton, Alberta, Canada
Contact: Romeo Felix     780-557-8048     romeo.felix@albertahealthservices.ca    
Canada, Ontario
Recruiting
Toronto, Ontario, Canada, M5G2M9
Contact: Nazanin Nouriany     416-946-4501 ext 5132     nazanin.nouriany@uhn.ca    
Canada, Quebec
Recruiting
Montreal, Quebec, Canada
Contact: Chantal Legare     514-890-8000 ext poste 26078     chantal.legare.chum@ssss.gouv.qc.ca    
Recruiting
Montreal, Quebec, Canada, H2W 1S6
Contact: Penny Chipman     514-398-1444     penny.chipman@mcgill.ca    
Germany
Recruiting
Heidelberg, Mannheim, Germany, 68167
Contact: Gerald Schmid-Bindert, MD     00 49 621 383-1498     gerald.schmid-bindert@medma.uni-heidelberg.de    
Recruiting
Bad Berka, Germany, 99437
Contact: Claus-Peter Schneider, MD         claus-peter.schneider@zentralklinik.de    
Recruiting
Frankfurt, Germany, 60488
Contact: Akin Atmaca, MD     +49 (0) 69-7601-1        
Recruiting
Heidelberg, Germany, 69126
Contact: Helge Bischoff, MD     +49 6221 3961350        
Recruiting
Leipzig, Germany, 04207
Contact: Ramona Dück     49 (0) 341/4231550     ramona.dueck@sanktgeorg.de    
Recruiting
Lungenklinik, Germany
Contact: Walburga Engel-Riedel, MD     0049-221-8907-13962        
Recruiting
Ulm, Germany, 89081
Contact: Christian Schumann     +49 (0) 731-500-45161     Christian.schumann@uniklinik-ulm.de    
Korea, Republic of
Recruiting
Seoul, Banp-dong Seocho-gu, Korea, Republic of, 137-701
Contact: Jin-Hyoung Kang, MD     82-2-2258-6043     jinkang@catholic.ac.kr    
Recruiting
Seoul, Gangnam-gu, Korea, Republic of, 135-710
Contact: Keun-Chil Park, MD     +82-2-3410-3459     keunchil.park@samsung.com    
Recruiting
Seoul, Seodaemun-gu, Korea, Republic of, 120-752
Contact: Byoung-Chul Cho, MD     +82-2-2228-8126     cbc1971@yuhs.ac    
Spain
Recruiting
Barcelona, Spain, 08035
Contact: Enriqueta Felip, MD         efelip@vhebron.net    
Recruiting
Madrid, Spain
Contact: Javier De Castro, MD         jcastro.hulp@salud.madrid.org    
Recruiting
Madrid, Spain
Contact: Mariano Provencio, MD         clinicaltrials.drprovencio3@gmail.com    
Recruiting
Malaga, Spain, 29010
Contact: Manuel Cobo, MD         manuelcobodols@yahoo.es    
Recruiting
Sevilla, Spain, 41013
Contact: Luis Paz-Ares, MD         luis.pazares.sspa@juntadeandalucia.es    
Taiwan
Recruiting
Guishan, Taoyuan County, Taiwan, 33305
Contact: Han-Pin Kuo, MD     +886-3-3281200 ext 8467     q8828@ms11.hinet.net    
Not yet recruiting
Kaohsiung, Taiwan
Contact: Chin-Chou Wang, MD     886-7-7317123 ext 8199     ccwang52@adm.cgmh.org.tw    
Recruiting
Taichung, Taiwan, 40705
Contact: Gee-Chen Chang, MD     886-4-23592525 ext 3259     August@vghtc.gov.tw    
Recruiting
Taichung, Taiwan
Contact: Te-Chun Hsia, MD     886-4-22052121 ext 1251     derrick.hsia@msa.hinet.net    
Recruiting
Tainan City, Taiwan, 70146
Contact: Wu-Chou Su, MD     886-6-2353535 ext 4289     sunnysu@mail.ncku.edu.tw    
Recruiting
Taipei, Taiwan, 100
Contact: Chih-Hsin Yang, MD     886-2-23123456 ext 67511     chihyang@ntu.edu.tw    
Sponsors and Collaborators
Merrimack Pharmaceuticals
Sanofi
Investigators
Study Director: Victor Moyo, MD Merrimack Pharmaceuticals
  More Information

No publications provided

Responsible Party: Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00994123     History of Changes
Other Study ID Numbers: MM-121-01-101 (ARD11585)
Study First Received: October 13, 2009
Last Updated: February 21, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Merrimack Pharmaceuticals:
Non-Small Cell Lung Cancer
NSCLC
Advanced Non-Small Cell Lung Cancer
Metastatic Non-Small Cell Lung Cancer
Lung Cancer
Erlotinib
Tarceva
 MM-121
ErbB3
Her3
Epidermal Growth Factor Receptor
anti-ErbB3 human monoclonal antibody
ErbB3 antagonist

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013