Know Cancer

forgot password

A Study of HSP90 Inhibitor AT13387 Alone and in Combination With Crizotinib in the Treatment of Non-small Cell Lung Cancer (NSCLC)

Phase 1/Phase 2
18 Years
Open (Enrolling)
Non-small Cell Lung Cancer(NSCLC)

Thank you

Trial Information

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Part A: The incidence of dose limiting toxicities when AT13387 is administered in combination with crizotinib.

Outcome Description:

- Number of patients with adverse events

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Jean-Charles Soria, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gustave Roussy, Cancer Campus, Grand Paris


United States: Food and Drug Administration

Study ID:




Start Date:

October 2012

Completion Date:

November 2014

Related Keywords:

  • Non-small Cell Lung Cancer(NSCLC)
  • Non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



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