NCT02695550

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_1 nonsmall-cell-lung-cancer

Timeline
Completed

Started Mar 2016

Shorter than P25 for phase_1 nonsmall-cell-lung-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

March 9, 2017

Status Verified

March 1, 2017

Enrollment Period

2 years

First QC Date

February 23, 2016

Last Update Submit

March 8, 2017

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (3)

  • Overall Response Rate (ORR) - Phase I

    Up to 24 month

  • Progression free survival (PFS) per RECIST v1.1 - Phase I

    Up to 24 months

  • Duration of response (DOR)

    Up to 24 months

Study Arms (1)

CT-707

EXPERIMENTAL

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

Drug: CT-707

Interventions

CT-707DRUG
CT-707

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Hospital of Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

Related Publications (2)

  • 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.

    PMID: 36424628DERIVED

  • 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.

    PMID: 30381078DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

conteltinib

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Yuankai Shi, Dr

    Cancer Hospital of Chines Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yong Peng, Dr.

CONTACT

86(10)88858866ypeng@centaurusbio.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2016

First Posted

March 1, 2016

Study Start

March 1, 2016

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

March 9, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)