A Phase 2 interventional study of XL647 in Non-small-cell Lung Cancer, sponsored by Kadmon Corporation, LLC. Completed at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-13.
Sponsored by Kadmon Corporation, LLC · Phase 2, Interventional, and Treatment
The purpose of this phase II study is to determine the safety, tolerability, and activity of XL647 in previously untreated subjects with non-small cell lung cancer (NSCLC). XL647 is a small molecule that potently inhibits multiple receptor kinases, including EGFR, VEGFR2 (KDR), ErbB2, and EphB4. Sensitivity to EGFR inhibitors has been linked to specific EGFR mutations and associated with certain clinical characteristics in patients with NSCLC (eg, female, minimal and remote smoking history, and adenocarcinoma histology).
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 55 is close to the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Kadmon Corporation, LLC is the lead sponsor of 20 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The subject meets any of the following cardiac criteria:
Patients received XL647 at an intermittent dosing schedule receiving drug for 5 days followed by 9 days without drug.
Drug: XL647
Patients received drug at a daily dosing schedule
Drug: XL647
XL647 will be administered orally as a single agent. XL647 will be supplied as 50 mg tablets. Subjects in the Intermittent 5 \& 9 cohort will receive XL647 at a dose of 350 mg on a 5 days on and 9 days off cycle every 2 weeks for 8 weeks. Subjects in the Daily Dosing cohort will receive XL647 administered daily as a single oral dose of 300 mg. In the absence of progressive disease (PD) and unacceptable XL647-related toxicity, subjects may continue to receive XL647 treatment on their assigned dosing schedule for up to 1 year on this study. Subjects who reach 1 year of treatment with no evidence of disease progression may, with the concurrence of the investigator and the sponsor, continue to receive therapy.
Response rate
Time frame: Inclusion until disease progression
Safety and tolerability
Time frame: Inclusion until 30 days post last treatment
Progression-free survival
Time frame: Inclusion until disease progression or death
Duration of response
Time frame: Inclusion until disease progression
Overall survival
Time frame: Inclusion until 180-Day Follow-up post last treatment
Pharmacokinetic and pharmacodynamic parameters
Time frame: At various time points from pre-dosing until post dosing
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Kadmon Corporation, LLC