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

  • Resize font
  • Print
  • Email
  • Facebook
  • Twitter
  • Google+
  • Pinterest

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, MD, Principal Investigator
    Medpace Recruitment, Center
    Ph: 1-866-872-2349
    Email: recruitment@medpace.com

    Trial Sites

    U.S.A.

    California
    La Jolla

    Rebecca and John Moores UCSD Cancer Center

    Lyudmila Bazhenova, MD
    Principal Investigator

    Los Angeles

    Jonsson Comprehensive Cancer Center at UCLA

    Jonathan Goldman, MD
    Principal Investigator

    USC/Norris Comprehensive Cancer Center and Hospital

    Barbara J. Gitlitz
    Principal Investigator

    San Diego

    Sharp Clinical Oncology Research-Sharp Memorial Hospital

    David Bodkin, MD
    Principal Investigator

    Whittier

    Innovative Clinical Research Institute

    Merrill Shum, MD
    Principal Investigator

    Colorado
    Aurora

    University of Colorado Cancer Center at UC Health Sciences Center

    David Ross Camidge
    Principal Investigator

    Delaware
    Newark

    Christiana Hospital

    Michael Guarino
    Principal Investigator

    Florida
    Orlando

    Florida Hospital Cancer Institute

    Tarek Mekhail
    Principal Investigator

    Tampa

    H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

    Alberto Chiappori
    Principal Investigator

    Illinois
    Chicago

    Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Jyoti Patel
    Principal Investigator

    University of Chicago Cancer Research Center

    Ravi Salgia
    Principal Investigator

    Michigan
    Detroit

    Barbara Ann Karmanos Cancer Institute

    Antoinette J. Wozniak
    Principal Investigator

    Minnesota
    Rochester

    Mayo Clinic Cancer Center

    Julian Molina
    Principal Investigator

    Missouri
    St. Louis

    Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

    Maria Baggstrom
    Principal Investigator

    Nebraska
    Omaha

    University of Nebraska Medical Center Eppley Cancer Center

    Apar Ganti, MD
    Principal Investigator

    New Hampshire
    Lebanon

    Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

    Konstantin H. Dragnev
    Principal Investigator

    New York
    Bronx

    Albert Einstein Cancer Center at Albert Einstein College of Medicine

    Bilal Piperdi, MD
    Principal Investigator

    Roman Perez-Soler, MD
    Principal Investigator

    New York

    Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

    Balazs Halmos, MD
    Principal Investigator

    North Carolina
    Greensboro

    Moses Cone Regional Cancer Center at Wesley Long Community Hospital

    Mohamed Mohamed, MD
    Principal Investigator

    Ohio
    Cincinnati

    Charles M. Barrett Cancer Center at University Hospital

    Nagla Karim
    Principal Investigator

    Oncology Hematology in Cincinnati

    David Waterhouse, MD
    Principal Investigator

    Cleveland

    Cleveland Clinic Taussig Cancer Center

    Nathan Pennell
    Principal Investigator

    Columbus

    Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center

    Erin M. Bertino
    Principal Investigator

    Oregon
    Portland

    Providence Cancer Center at Providence Portland Medical Center

    Rachel E. Sanborn
    Principal Investigator

    Pennsylvania
    Hershey

    Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center

    Chandra Prakash Belani, MD
    Principal Investigator

    Philadelphia

    Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

    Barbara Campling
    Principal Investigator

    Tennessee
    Memphis

    West Clinic - East Memphis

    Daruka Mahadevan, MD
    Principal Investigator

    Nashville

    Sarah Cannon Research Institute

    David Spigel, MD
    Principal Investigator

    Texas
    Dallas

    Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

    Joan Hoff Schiller
    Principal Investigator

    Virginia
    Fairfax

    Virginia Cancer Specialists

    Alexander Spira
    Principal Investigator

    Washington
    Seattle

    Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

    Howard Lawrence West
    Principal Investigator

    Wisconsin
    Madison

    University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

    Ticiana Leal, MD
    Principal Investigator

    Canada

    Montreal, Quebec

    McGill University Health Center

    Vera Hirsh
    Principal Investigator

    Sainte-Foy, Quebec

    Fondation de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

    Lise Tremblay
    Principal Investigator

    Toronto, Ontario

    Princess Margaret Hospital

    Geoffrey Liu, MD
    Principal Investigator

    Winnipeg

    Cancer Care Manitoba

    Shantanu Banerji
    Principal Investigator

    Nova Scotia
    Halifax

    Atlantic Clinical Cancer Research Unit

    Wojciech Morzycki
    Principal Investigator

    France

    Besancon Cedex

    Centre Hospitalier Regional Universitaire Besancon

    Virginie Westeel, MD
    Principal Investigator

    Caen

    CHU de Caen

    Gerard Zalcman, MD
    Principal Investigator

    Creteil Cedex

    Hopital Saint Antoine

    Christos Chouaid
    Principal Investigator

    Grenoble

    Centre Hospitalier de Grenoble

    Denis Moro-Sibilot
    Principal Investigator

    Lille cedex

    Centre Hospitalier Regional et Universitaire de Lille

    Alexis Cortot, MD
    Principal Investigator

    Marseille

    Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

    Anne Madroszyk, MD
    Principal Investigator

    Paris

    Hopital Tenon

    Marie Wislez, MD
    Principal Investigator

    Pierre-Benite Cedex

    Centre Hospitalier Lyon Sud

    Pierre-Jean Souquet
    Principal Investigator

    Toulouse

    CHU Toulouse-Hopital Larrey

    Julien Mazieres, MD
    Principal Investigator

    Villejuif

    Institut Gustave Roussy

    Benjamin Besse, MD
    Principal Investigator

    Republic of Korea

    Hwasun-gun Jeonnam

    Chonnam National University Hwasun Hospital

    In Jae Oh
    Principal Investigator

    Korea

    National Cancer Center

    Ji-Youn HAN
    Principal Investigator

    Seongnam

    Seoul National University Bundang Hospital

    Jong-Seok LEE
    Principal Investigator

    Seoul

    Asan Medical Center - University of Ulsan College of Medicine

    Dae Ho Lee
    Principal Investigator

    Samsung Medical Center

    Myung-Ju Ahn
    Principal Investigator

    Yonsei Cancer Center at Yonsei University Medical Center

    Joo Hang Kim
    Principal Investigator

    Link to the current ClinicalTrials.gov record.
    NLM Identifier NCT01712217
    ClinicalTrials.gov processed this data on May 15, 2015

    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.