A Study of HSP90 Inhibitor AT13387 Alone and in Combination With Crizotinib in the Treatment of Non-small Cell Lung Cancer (NSCLC)
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.
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Part A: The incidence of dose limiting toxicities when AT13387 is administered in combination with crizotinib.
- Number of patients with adverse events
12 months
Yes
Jean-Charles Soria, MD
Principal Investigator
Gustave Roussy, Cancer Campus, Grand Paris
United States: Food and Drug Administration
AT13387-05
NCT01712217
October 2012
November 2014
Name | Location |
---|---|
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
Washington University School of Medicine | Saint Louis, Missouri 63110 |
University of Washington Medical Center | Seattle, Washington 98195-6043 |
Montefiore Medical Center | Bronx, New York 10467-2490 |
Duke University Medical Center | Durham, North Carolina 27710 |
Cleveland Clinic | Cleveland, Ohio 44195 |
Ohio State University Medical Center | Columbus, Ohio 43210 |
Thomas Jefferson University | Philadelphia, Pennsylvania 19107-6541 |
H. Lee Moffitt Cancer Center & Research Institute | Tampa, Florida 33612 |
Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
Providence Portland Medical Center | Portland, Oregon 97213-3635 |
University of Chicago | Chicago, Illinois 60637 |
USC Norris Comprehensive Cancer Center | Los Angeles, California 90089 |
University of Texas Southwestern Medical Center | Dallas, Texas |
University of California, San Diego Medical Center | San Diego, California |
University of Colorado Denver | Denver, Colorado 80262 |
The West Clinic | Memphis, Tennessee 38120 |
Columbia University Medical Center | New York, New York 10032 |
Christiana Hospital | Wilmington, Delaware |
Mayo Clinic-Rochester | Rochester, Minnesota 55905 |
Northwestern University The Feinberg School of Medicine | Chicago, Illinois 60611 |
Mayo Clinic-Scottsdale | Scottsdale, Arizona 85259 |
Virginia Cancer Specialists | Fairfax, Virginia |
Cone Health Cancer Center | Greensboro, North Carolina |
University of Cincinnati Cancer Institute | Cincinnati, Ohio 45267 |
Innovative Clinical Research Institute | Downey, California 90241 |
Yale University School of Medicine-Yale Cancer Center | New Haven, Connecticut 06519 |
Indiana University Melvin and and Bren Simon Cancer Center | Indianapolis, Indiana 46202 |
University of Wisconsin-Carbone Cancer Center | Madison, Wisconsin 53705 |