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

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02695550
• Other study ID #: CT-707-101
• Status: Recruiting
• Phase: Phase 1
• First received: February 23, 2016
• Last updated: March 8, 2017
• Start date: March 2016
• Est. completion date: March 2018

Study information

• Verified date: March 2017
• Source: Centaurus Biopharma Co., Ltd.
• Contact: Yong Peng, Dr.
• Phone: 86(10)88858866
• Email: ypeng[@]centaurusbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• CT-707

Locations

Country	Name	City	State
China	Cancer Hospital of Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Centaurus Biopharma Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rate of dose limiting toxicities (DLTs) during the first cycle of treatment (Phase I)	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	28 days
Primary	Frequency of adverse events/serious adverse events	Characterization of the safety and tolerability of CT-707 as determined by changes in laboratory values and electrocardiograms	Up to 24 months
Secondary	Overall Response Rate (ORR) - Phase I	Preliminary measure of anti-tumor activity of CT-707	Up to 24 month
Secondary	Progression free survival (PFS) per RECIST v1.1 - Phase I	Preliminary measures of anti-tumor activity of CT-707	Up to 24 months
Secondary	Duration of response (DOR)	Preliminary measure of anti-tumor activity of CT-707	Up to 24 months