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

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Basic Trial Information

PhaseTypeAgeTrial IDs
Phase II, Phase IBiomarker/Laboratory analysis, Treatment18 and overAT13387-05
NCI-2012-02034, 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:

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

Exclusion 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 / Collaborators

Astex Pharmaceuticals

    Trial Sites

    U.S.A.

    Arizona
    Scottsdale

    Mayo Clinic in Arizona

    Helen Jane Ross
    Principal Investigator

    California
    Los Angeles

    UCLA / Jonsson Comprehensive Cancer Center

    Jonathan W. Goldman
    Principal Investigator

    Colorado
    Aurora

    University of Colorado Cancer Center - Anschutz Cancer Pavilion

    Ross Camidge
    Principal Investigator

    Illinois
    Chicago

    University of Chicago Comprehensive Cancer Center

    Ravi Salgia
    Principal Investigator

    Indiana
    Indianapolis

    Indiana University/Melvin and Bren Simon Cancer Center

    Shadia Ibrahim Jalal
    Principal Investigator

    Michigan
    Detroit

    Barbara Ann Karmanos Cancer Institute

    Antoinette J. Wozniak
    Principal Investigator

    Minnesota
    Rochester

    Mayo Clinic

    Julian R. Molina
    Principal Investigator

    Missouri
    Saint Louis

    Siteman Cancer Center at Washington University

    Maria Quintos Baggstrom
    Principal Investigator

    New York
    New York

    Columbia University Medical Center

    Balazs Halmos
    Principal Investigator

    Texas
    Dallas

    UT Southwestern/Simmons Cancer Center-Dallas

    Joan Hoff Schiller
    Principal Investigator

    Washington
    Seattle

    Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

    Renato Goncalves Martins
    Principal Investigator

    Link to the current ClinicalTrials.gov record.
    NLM Identifer NCT01712217

    Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.