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Study of CX-4945 in Combination With Gemcitabine and Cisplatin for Frontline Treatment of Cholangiocarcinoma

NCT02128282 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2021-10-22

No results posted yet for this study

Summary

This study considers the safety and tolerability of increasing doses of CX-4945 in combination with gemcitabine plus cisplatin to determine the maximum tolerated dose (MTD) and the recommended Phase II dose (RP2D), followed by a randomized study that compares antitumor activity in cholangiocarcinoma patients receiving the standard of care gemcitabine plus cisplatin versus CX-4945 at the combination RP2D with gemcitabine plus cisplatin.

Conditions

Interventions

DRUG

CX-4945

API powder-in-capsule in 200 mg strength.

DRUG

Cisplatin

25 mg/m.sq. administered by IV infusion on Days 1 and 8 of a 21-day cycle.

DRUG

Gemcitabine

1,000 mg/m.sq. administered by IV infusion on Days 1 and 8 of a 21-day cycle.

Sponsors & Collaborators

  • Senhwa Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Mitesh Borad, M.D. · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2020-11-06
Completion
2021-08-05

Countries

  • United States
  • South Korea
  • Taiwan

Study Locations

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Entities

Drugs
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 NCT02128282 on ClinicalTrials.gov