Study of Safety, Efficacy and Pharmacokinetics of CT-707 in Patients With ALK-positive Non-small Cell Lung Cancer

Brief Title

Study of Safety, Efficacy and Pharmacokinetics of CT-707 in Patients With ALK-positive Non-small Cell Lung Cancer

Official Title

Study of Safety, Efficacy and Pharmacokinetics of CT-707 in Patients With ALK-positive Non-small Cell Lung Cancer

Brief Summary

      This is a Phase I study of the ALK/FAK/Pyk2 inhibitor CT-707 in patients with ALK-positive
      non-small cell lung cancer.

      The purpose of the study is to determine the MTD/RP2D of CT-707 and evaluate whether CT-707
      is safe and has beneficial effects in ALK-positive advanced non-small cell lung cancer.
    

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

Incidence rate of dose limiting toxicities (DLTs) during the first cycle of treatment (Phase I)

Secondary Outcome

 Overall Response Rate (ORR) - Phase I

Condition

Non-small Cell Lung Cancer

Intervention

CT-707

Study Arms / Comparison Groups

 CT-707

Description:  ALK-positive non-small cell lung cancer resistant to Crizotinib treatment

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

40

Start Date

March 2016

Completion Date

March 2018

Primary Completion Date

March 2018

Eligibility Criteria

        Inclusion Criteria:

        Patients must be diagnosed with ALK-positive advanced NSCLC. The tumor must be ALK-positive
        as determined by ALK rearrangement in ≥15% of cells (as measured by FISH using the Vysis
        break-apart ALK probe) or by using the Ventana ALK IHC test. The analysis may be performed
        locally.

        Eastern cooperative oncology group (ECOG) performance status ≤ 2. Measurable disease as per
        RECIST v1.1

        Availability of tumor sample:

        Exclusion Criteria:

        Patients with symptomatic central nervous system (CNS) metastases who are neurologically
        unstable or require increasing doses of steroids or local CNS-directed therapy to control
        their CNS disease Impaired cardiac function or any clinically significant cardiac disease
        Patients with abnormal laboratory values during screening and on day 1 of pre-dose
        Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the
        absorption of CT-707 Patient has a history of pancreatitis or history of increased amylase
        or lipase that was due to pancreatic disease.

        Other protocol-defined inclusion/exclusion criteria may apply.
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Yuankai Shi, Dr, 86(10)88858866, [email protected]

Location Countries

China

Location Countries

China

NCT ID

NCT02695550

Organization ID

CT-707-101

Responsible Party

Sponsor

Study Sponsor

Centaurus Biopharma Co., Ltd.

Study Sponsor

Yuankai Shi, Dr, Principal Investigator, Cancer Hospital of Chines Academy of Medical Sciences

Verification Date

March 2017