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NCT02128282 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Cholangiocarcinoma, sponsored by Senhwa Biosciences.

Completed
Registry status
Phase 1
Development phase
127
Enrollment target
16
Study locations

NCT02128282 is a Phase 1 study of Cholangiocarcinoma that has completed, run by Senhwa Biosciences. The registered enrollment target is 127 participants, below the 384-participant average among 60 other Cholangiocarcinoma trials with a reported enrollment target (67% lower). The trial reports 16 study locations across 7 states.

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The verdict

NCT02128282, a Phase 1 study of Cholangiocarcinoma, has completed, sponsored by Senhwa Biosciences.

COMPLETED
Registry status
Phase 1
Development phase
127 participants
Enrollment target
16
Study locations

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 Studied

Cholangiocarcinoma

Interventions

  • DRUG Cisplatin
  • DRUG Gemcitabine
  • DRUG CX-4945

Study Locations (16)

Other

  • Samsung Medical Center - Seoul
  • Seoul National University Hospital - Seoul
  • Severance Hospital, Yonsei University Health System - Seoul
  • Chang-Gung Memorial Hospital - Kaohsiung Branch - Kaohsiung City
  • China Medical University Hospital - Taichung
  • National Cheng Kung University Hospitals - Tainan
  • National Taiwan University Hospital - Taipei
  • Taipei Veterans General Hospital - Taipei
  • Chang-Gung Memorial Hospital - Linkou Branch - Taoyuan

Texas

  • Texas Oncology - Baylor Charles A. Sammons Cancer Center - Dallas
  • Texas Oncology-Tyler - Tyler

Arizona

  • Mayo Clinic - Scottsdale

Colorado

  • University of Colorado- Denver - Aurora

Florida

  • Mayo Clinic - Jacksonville

Minnesota

  • Mayo Clinic - Rochester

Songpa-gu

  • Asan Medical Center - Seoul

Trial Details

FieldValue
Enrollment Target 127 participants
Start Date 2014-06
Est. Completion 2021-08-05
Phase Phase 1

Sponsor

Senhwa Biosciences

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02128282

The ClinicalTrials.gov registry entry for NCT02128282 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 127 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 384-participant average among 60 other Cholangiocarcinoma trials with a reported enrollment target (67% lower). The listed sponsor is Senhwa Biosciences, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Cholangiocarcinoma appearing as the primary indexed condition, and to 3 interventions - of which Cisplatin is the first listed.

NCT02128282 reports 16 study locations spanning 7 distinct geographic areas - top geographies include Other, Texas, Arizona.

Frequently Asked Questions

What is clinical trial NCT02128282 about?

NCT02128282 is a clinical study titled "Study of CX-4945 in Combination With Gemcitabine and Cisplatin for Frontline Treatment of Cholangiocarcinoma". 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...

What is the current status of trial NCT02128282?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 127 participants. The study started on 2014-06. Estimated completion is 2021-08-05.

What conditions does trial NCT02128282 study?

This clinical trial studies the following conditions: Cholangiocarcinoma.

What interventions are being tested in trial NCT02128282?

The interventions under investigation include: Cisplatin (DRUG), Gemcitabine (DRUG), CX-4945 (DRUG).

Who is sponsoring clinical trial NCT02128282?

This trial is sponsored by Senhwa Biosciences, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02128282 being conducted?

This trial has 16 study locations across Arizona, Colorado, Florida, Minnesota, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.