A Trial of BXCL701 and Pembrolizumab in Patients With mCRPC Either Small Cell Neuroendocrine Prostate Cancer or Adenocarcinoma Phenotype.

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

98

Participants

Timeline

Start Date

February 12, 2019

Primary Completion Date

October 31, 2023

Study Completion Date

December 12, 2024

Conditions
Prostate CancerNeuroendocrine TumorsSmall Cell Carcinoma
Interventions
DRUG

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."

DRUG

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."

Trial Locations (12)

10021

Weill Cornell Medicine New York, New York

10601

White Plains Hospital Center for Cancer Care, White Plains

11042

Center for Advanced Medicine / R.J. Zuckerberg Cancer Center (Northwell Health Cancer Institute), Lake Success

33612

Moffitt Cancer Center and Research Institute, Tampa

43210

The Ohio State University, Columbus

48201

BioXcel Clinical Research Site, Detroit

80211

BioXcel Clinical Research Site, Denver

94158

University of California San Francisco (UCSF), San Francisco

06510

Yale University, New Haven

G12 0YN

BioXcel Clinical Research Site, Glasgow

W1T 7HA

BioXcel Clinical Research Site, London

SM2 5NG

BioXcel Clinical Research Site, Sutton

Sponsors
All Listed Sponsors
lead

BioXcel Therapeutics Inc

INDUSTRY