A Phase 1 interventional study of CT-707 in Non-small Cell Lung Cancer, sponsored by Centaurus Biopharma Co., Ltd.. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-03-09.
Sponsored by Centaurus Biopharma Co., Ltd. · Phase 1, Interventional, and Treatment
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Centaurus Biopharma Co., Ltd. is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
ALK-positive non-small cell lung cancer resistant to Crizotinib treatment
Drug: CT-707
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
Time frame: 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
Time frame: Up to 24 months
Overall Response Rate (ORR) - Phase I
Preliminary measure of anti-tumor activity of CT-707
Time frame: Up to 24 month
Progression free survival (PFS) per RECIST v1.1 - Phase I
Preliminary measures of anti-tumor activity of CT-707
Time frame: Up to 24 months
Duration of response (DOR)
Preliminary measure of anti-tumor activity of CT-707
Time frame: Up to 24 months
Plan to share: No
This study is status unknown, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Centaurus Biopharma Co., Ltd.