Clinical Trials /

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

NCT02695550

Description:

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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Unknown status

Phase:

Phase 1

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: CT-707-101
  • NCT ID: NCT02695550

Conditions

  • Non-small Cell Lung Cancer

Interventions

DrugSynonymsArms
CT-707CT-707

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
CT-707ExperimentalALK-positive non-small cell lung cancer resistant to Crizotinib treatment
  • CT-707

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.
      
Maximum Eligible Age:65 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence rate of dose limiting toxicities (DLTs) during the first cycle of treatment (Phase I)
Time Frame:28 days
Safety Issue:
Description:Maximum Tolerated Dose(s) (MTD(s)) and/or recommended phase 2 dose (RP2D(s)) of CT-707 in ALK-positive non-small cell lung cancer (NSCLC) patients. Cycle = 28 days

Secondary Outcome Measures

Measure:Overall Response Rate (ORR) - Phase I
Time Frame:Up to 24 month
Safety Issue:
Description:Preliminary measure of anti-tumor activity of CT-707
Measure:Progression free survival (PFS) per RECIST v1.1 - Phase I
Time Frame:Up to 24 months
Safety Issue:
Description:Preliminary measures of anti-tumor activity of CT-707
Measure:Duration of response (DOR)
Time Frame:Up to 24 months
Safety Issue:
Description:Preliminary measure of anti-tumor activity of CT-707

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Centaurus Biopharma Co., Ltd.

Last Updated

March 8, 2017