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

NCT ID: NCT02695550

Last Updated: 2017-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2018-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Non-small Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CT-707

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

Group Type EXPERIMENTAL

CT-707

Intervention Type DRUG

Interventions

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CT-707

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centaurus Biopharma Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yuankai Shi, Dr

Role: PRINCIPAL_INVESTIGATOR

Cancer Hospital of Chines Academy of Medical Sciences

Locations

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Cancer Hospital of Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yong Peng, Dr.

Role: CONTACT

86(10)88858866

Facility Contacts

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Yuankai Shi, M.D.

Role: primary

86(10)67781331

References

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Xing P, Zhao Q, Zhang L, Wang H, Huang D, Hu P, Sun Y, Shi Y. Conteltinib (CT-707) in patients with advanced ALK-positive non-small cell lung cancer: a multicenter, open-label, first-in-human phase 1 study. BMC Med. 2022 Nov 23;20(1):453. doi: 10.1186/s12916-022-02646-0.

Reference Type DERIVED
PMID: 36424628 (View on PubMed)

Liang C, Zhang N, Tan Q, Liu S, Luo R, Wang Y, Shi Y, Han X. CT-707 Overcomes Resistance of Crizotinib through Activating PDPK1- AKT1 Pathway by Targeting FAK. Curr Cancer Drug Targets. 2019;19(8):655-665. doi: 10.2174/1568009618666181031152140.

Reference Type DERIVED
PMID: 30381078 (View on PubMed)

Other Identifiers

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CT-707-101

Identifier Type: -

Identifier Source: org_study_id

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