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COMPLETED Phase 1

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

NCT02128282 · View on ClinicalTrials.gov ↗

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

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

3 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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 127 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Senhwa Biosciences, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02128282 reports 16 study locations spanning 7 distinct geographic areas — top geographies include Other, Texas, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02128282?

The interventions under investigation include: Cisplatin (DRUG), Gemcitabine (DRUG), CX-4945 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02128282?

This trial is sponsored by Senhwa Biosciences, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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