98
Participants
Start Date
February 12, 2019
Primary Completion Date
October 31, 2023
Study Completion Date
December 12, 2024
BXCL701 plus Pembrolizumab
"BXCL701 tablets dosage strengths include 0.05mg and 1mg tablets for oral administration.~BXCL701 will be administered orally as 0.05mg and 1mg tablets. Patients will take the prescribed number of tablets on Days 1 to 14 of each cycle, for a total daily dose of 0.4 mg, 0.6 mg, or an intermediate dose. BXCL701 will be continued until PD or unacceptable toxicity, or closure of the study by the sponsor; no maximum duration of therapy has been set.~BXCL701 should not be taken on an empty stomach.~On days when PD studies are being performed, BXCL701 should be administered at the study center and should be administered at approx. the same time of day on each treatment day in the cycle. In cycles in which PD are not evaluated, BXCL701 also should be administered at approx. the same time of day on each treatment day.~The PEMBRO dose will be 200 mg, administered as an IV infusion over 30 mins. on Day 1 of each 21-day cycle."
BXCL701 monotherapy
"BXCL701 tablets dosage strengths include 0.05mg and 1mg tablets for oral administration.~BXCL701 will be administered orally as 0.05mg and 1mg tablets. Patients will take the prescribed number of tablets on Days 1 to 14 of each cycle, for a total daily dose of 0.4 mg, 0.6 mg, or an intermediate dose. BXCL701 will be continued until PD or unacceptable toxicity, or closure of the study by the sponsor; no maximum duration of therapy has been set.~BXCL701 should not be taken on an empty stomach.~On days when PD studies are being performed, BXCL701 should be administered at the study center and should be administered at approx. the same time of day on each treatment day in the cycle. In cycles in which PD are not evaluated, BXCL701 also should be administered at approx. the same time of day on each treatment day."
Weill Cornell Medicine New York, New York
White Plains Hospital Center for Cancer Care, White Plains
Center for Advanced Medicine / R.J. Zuckerberg Cancer Center (Northwell Health Cancer Institute), Lake Success
Moffitt Cancer Center and Research Institute, Tampa
The Ohio State University, Columbus
BioXcel Clinical Research Site, Detroit
BioXcel Clinical Research Site, Denver
University of California San Francisco (UCSF), San Francisco
Yale University, New Haven
BioXcel Clinical Research Site, Glasgow
BioXcel Clinical Research Site, London
BioXcel Clinical Research Site, Sutton
Lead Sponsor
BioXcel Therapeutics Inc
INDUSTRY