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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
N/A
Open (Enrolling)
Both
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:

Interventional

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:

Yes

Principal Investigator

Jean-Charles Soria, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gustave Roussy, Cancer Campus, Grand Paris

Authority:

United States: Food and Drug Administration

Study ID:

AT13387-05

NCT ID:

NCT01712217

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

Name

Location

Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
Washington University School of MedicineSaint Louis, Missouri  63110
University of Washington Medical CenterSeattle, Washington  98195-6043
Montefiore Medical CenterBronx, New York  10467-2490
Duke University Medical CenterDurham, North Carolina  27710
Cleveland ClinicCleveland, Ohio  44195
Ohio State University Medical CenterColumbus, Ohio  43210
Thomas Jefferson UniversityPhiladelphia, Pennsylvania  19107-6541
H. Lee Moffitt Cancer Center & Research InstituteTampa, Florida  33612
Dana Farber Cancer InstituteBoston, Massachusetts  02115
Providence Portland Medical CenterPortland, Oregon  97213-3635
University of ChicagoChicago, Illinois  60637
USC Norris Comprehensive Cancer CenterLos Angeles, California  90089
University of Texas Southwestern Medical CenterDallas, Texas  
University of California, San Diego Medical CenterSan Diego, California  
University of Colorado DenverDenver, Colorado  80262
The West ClinicMemphis, Tennessee  38120
Columbia University Medical CenterNew York, New York  10032
Christiana HospitalWilmington, Delaware  
Mayo Clinic-RochesterRochester, Minnesota  55905
Northwestern University The Feinberg School of MedicineChicago, Illinois  60611
Mayo Clinic-ScottsdaleScottsdale, Arizona  85259
Virginia Cancer SpecialistsFairfax, Virginia  
Cone Health Cancer CenterGreensboro, North Carolina  
University of Cincinnati Cancer InstituteCincinnati, Ohio  45267
Innovative Clinical Research InstituteDowney, California  90241
Yale University School of Medicine-Yale Cancer CenterNew Haven, Connecticut  06519
Indiana University Melvin and and Bren Simon Cancer CenterIndianapolis, Indiana  46202
University of Wisconsin-Carbone Cancer CenterMadison, Wisconsin  53705