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A Pilot Study of BXCL701 in Patients With Pancreatic Cancer

NCT04123574 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL

Last updated 2022-02-24

No results posted yet for this study

Summary

A study to assess the biochemical and immunomodulatory effects of BXCL701 in pancreatic cancer.

Conditions

  • Cancer of Pancreas
  • Cancer of the Pancreas
  • Neoplasms, Pancreatic
  • Pancreas Cancer
  • Pancreatic Cancer

Interventions

DRUG

Talabostat Mesylate

BXCL701 tablets dosage strengths include 0.2mg and 0.05mg tablets for oral administration. Patients are to self-administer the prescribed number of BXCL701 tablets for a total daily dose of 0.6 mg. BXCL701 should not be taken on an empty stomach. Daily blood pressure monitoring will be performed during the dosing period. Administration of at least 1L of intravenous (IV) fluids is required on Day 1. On days when pharmacokinetic (PK) assessments are being performed, BXCL701 should be administered at the study center and should be administered at (approximately) the same time of day on each treatment day.

Sponsors & Collaborators

  • IQVIA Biotech

    collaborator INDUSTRY

  • BioXcel Therapeutics Inc

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-15
Primary Completion
2021-12-06
Completion
2021-12-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04123574 on ClinicalTrials.gov