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Clinical Trials (PDQ®)

A Study of AT13387 in Patients With Non-Small Cell Lung Cancer (NSCLC) Alone and in Combination With Crizotinib

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase II, Phase IBiomarker/Laboratory analysis, TreatmentActive18 and overPharmaceutical / IndustryAT13387-05
2012-001575-37, NCT01712217

Trial Description

Summary

The purpose of the study is to evaluate safety and efficacy of AT13387 Alone and in Combination with Crizotinib in the Treatment of Non-small Cell Lung Cancer.

Further Study Information

This is a 3-part phase 1-2 study in patients with anaplastic lymphoma kinase (ALK) + or other potentially crizotinib-sensitive NSCLC who have been receiving crizotinib. Part A is a single-arm, Phase 1, open-label, dose escalation design in patients with NSCLC who have already been receiving crizotinib for at least 8 weeks and continue to tolerate therapy. Part B is a Phase 2, open-label, randomized continuation design comparing crizotinib alone versus the combination of crizotinib + AT13387 at the maximum tolerated dose established in Part A. Part C is an open-label, randomized, Phase 2, Simon's 2 stage design evaluating single agent AT13387 or combination AT13387 + crizotinib at the MTD established in Part A in patients who progressed on crizotinib at any time.

Eligibility Criteria

Inclusion Criteria:

1. Men or women 18 years of age or older

2. Must have Non-small Cell Lung Cancer with ALK+ mutation or other mutations or rearrangements potentially sensitive to crizotinib

3. Measurable disease

4. Must have been receiving or have received crizotinib

5. Have adequate cardiac, bone marrow, liver and kidney function

6. Must be willing and able to provide written informed consent and comply with the protocol and study procedures

Exclusion Criteria:

1. Prior anti-cancer treatment with any HSP90 inhibitor

2. Have received chemotherapy, radiation therapy or other anticancer treatment other than crizotinib within 3 weeks prior to the first dose of study drug

3. Prior malignancy other than adequately treated basal or squamous cell carcinoma of the skin, superficial bladder cancer, low-grade cervical cancer, non-metastatic prostate cancer, or have been disease-free for at least 3 years

4. Abnormal heart function

5. Presence of a life-threatening illness, medical condition, organ system dysfunction, or other factors

6. Hypersensitivity of AT13387 or other components of the drug product

7. Treatment with an investigational drug within 3 weeks prior to the first dose of study drug

8. Severe systemic diseases or active uncontrolled infections

9. Known history of human immunodeficiency virus (HIV) or seropositive test for hepatitis C virus or hepatitis B virus

Trial Contact Information

Trial Lead Organizations/Sponsors

Astex Therapeutics

Jean-Charles Soria, MDPrincipal Investigator

Medpace Recruitment, CenterPh: 1-866-872-2349
  Email: recruitment@medpace.com

Trial Sites

U.S.A.
Arizona
  Scottsdale
 Mayo Clinic Scottsdale
 Helen Ross, MDPrincipal Investigator
California
  La Jolla
 Rebecca and John Moores UCSD Cancer Center
 Lyudmila Bazhenova, MDPrincipal Investigator
  Los Angeles
 USC/Norris Comprehensive Cancer Center and Hospital
 Barbara J. GitlitzPrincipal Investigator
  San Diego
 Sharp Clinical Oncology Research-Sharp Memorial Hospital
 David Bodkin, MDPrincipal Investigator
  Santa Monica
 Santa Monica UCLA Medical Center
 Jonathan Goldman, MDPrincipal Investigator
  Whittier
 Innovative Clinical Research Institute
 Merrill Shum, MDPrincipal Investigator
Colorado
  Aurora
 University of Colorado Cancer Center at UC Health Sciences Center
 David Ross CamidgePrincipal Investigator
Connecticut
  New Haven
 Yale Cancer Center
 Scott Gettinger, MDPrincipal Investigator
Delaware
  Newark
 Christiana Hospital
 Michael GuarinoPrincipal Investigator
Florida
  Orlando
 Florida Hospital Cancer Institute
 Tarek MekhailPrincipal Investigator
  Tampa
 H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
 Alberto ChiapporiPrincipal Investigator
Illinois
  Chicago
 Robert H. Lurie Comprehensive Cancer Center at Northwestern University
 Jyoti PatelPrincipal Investigator
 University of Chicago Cancer Research Center
 Ravi SalgiaPrincipal Investigator
Michigan
  Detroit
 Barbara Ann Karmanos Cancer Institute
 Antoinette Wozniak, MDPrincipal Investigator
Minnesota
  Rochester
 Mayo Clinic Cancer Center
 Julian MolinaPrincipal Investigator
Missouri
  St. Louis
 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
 Maria BaggstromPrincipal Investigator
Nebraska
  Omaha
 University of Nebraska Medical Center Eppley Cancer Center
 Apar Ganti, MDPrincipal Investigator
New Hampshire
  Lebanon
 Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
 Konstantin H. DragnevPrincipal Investigator
New York
  Bronx
 Albert Einstein Cancer Center at Albert Einstein College of Medicine
 Bilal Piperdi, MDPrincipal Investigator
  New York
 Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
 Balazs Halmos, MDPrincipal Investigator
North Carolina
  Greensboro
 Moses Cone Regional Cancer Center at Wesley Long Community Hospital
 Mohamed Mohamed, MDPrincipal Investigator
Ohio
  Cincinnati
 Charles M. Barrett Cancer Center at University Hospital
 Nagla KarimPrincipal Investigator
 Oncology Hematology in Cincinnati
 David Waterhouse, MDPrincipal Investigator
  Cleveland
 Cleveland Clinic Taussig Cancer Center
 Nathan PennellPrincipal Investigator
  Columbus
 Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
 Erin Bertino, MDPrincipal Investigator
Oregon
  Portland
 Providence Cancer Center at Providence Portland Medical Center
 Rachel E. SanbornPrincipal Investigator
Pennsylvania
  Hershey
 Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
 Chandra Prakash Belani, MDPrincipal Investigator
  Philadelphia
 Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
 Barbara CamplingPrincipal Investigator
Tennessee
  Memphis
 West Clinic - East Memphis
 Daruka Mahadevan, MDPrincipal Investigator
  Nashville
 Sarah Cannon Research Institute
 David Spigel, MDPrincipal Investigator
Texas
  Dallas
 Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
 Joan Hoff SchillerPrincipal Investigator
Virginia
  Fairfax
 Virginia Cancer Specialists
 Alexander SpiraPrincipal Investigator
Washington
  Seattle
 Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
 Howard Lawrence WestPrincipal Investigator
 University Cancer Center at University of Washington Medical Center
 Renato MartinsPrincipal Investigator
Wisconsin
  Madison
 University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
 Ticiana Leal, MDPrincipal Investigator
France
  Besancon Cedex
 Centre Hospitalier Regional Universitaire Besancon
 Virginie Westeel, MDPrincipal Investigator
  Caen
 CHU de Caen
 Gerard Zalcman, MDPrincipal Investigator
  Grenoble
 Centre Hospitalier de Grenoble
 Denis Moro-SibilotPrincipal Investigator
  Lille cedex
 Centre Hospitalier Regional et Universitaire de Lille
 Alexis Cortot, MDPrincipal Investigator
  Marseille
 Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
 Anne Madroszyk, MDPrincipal Investigator
  Paris
 Hopital Tenon
 Marie Wislez, MDPrincipal Investigator
  Pierre-Benite Cedex
 Centre Hospitalier Lyon Sud
 Pierre-Jean SouquetPrincipal Investigator
  Toulouse
 CHU Toulouse-Hopital Larrey
 Julien Mazieres, MDPrincipal Investigator
  Villejuif
 Institut Gustave Roussy
 Benjamin Besse, MDPrincipal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01712217
ClinicalTrials.gov processed this data on October 20, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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