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

C

Centaurus Biopharma

Status and phase

Unknown
Phase 1

Conditions

Non-small Cell Lung Cancer

Treatments

Drug: CT-707

Study type

Interventional

Funder types

Industry

Identifiers

NCT02695550
CT-707-101

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

CT-707
Experimental group
Description:
ALK-positive non-small cell lung cancer resistant to Crizotinib treatment
Treatment:
Drug: CT-707

Trial contacts and locations

1

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Central trial contact

Yong Peng, Dr.

Data sourced from clinicaltrials.gov

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