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Dose-escalation, Safety and Pharmacokinetic Study of Briciclib in Advanced Solid Tumors

NCT02168725 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2021-06-22

No results posted yet for this study

Summary

The main objectives of this study are to determine the safety profile of briciclib, an experimental anti-cancer drug, as it is administered intravenously once weekly as escalating doses in adult patients with advanced cancer and solid tumors, and to determine the highest dose of briciclib that can be safely given. Secondary objectives are to determine how the amount of briciclib in circulation changes over time and how much briciclib gets into the urine for excretion, and to document potential anti-tumor effects of briciclib.

Conditions

  • Neoplasms
  • Advanced Solid Tumor

Interventions

DRUG

briciclib

Sponsors & Collaborators

  • Traws Pharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Antonio Jimeno, MD, PhD · University of Colorado, Denver

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States

Study Locations

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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 NCT02168725 on ClinicalTrials.gov