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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: Completed Phase 1 study of Cholangiocarcinoma, sponsored by Senhwa Biosciences.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The Maximum Tolerated Dose of CX-4945 will be determined from safety observations during the first cycle, as the CX-4945 dose is escalated in cohorts of three patients in combination with standard 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
| Field | Value |
|---|---|
| Enrollment Target | 127 participants |
| Start Date | 2014-06 |
| Est. Completion | 2021-08-05 |
| Phase | Phase 1 |
What the finished NCT02128282 record still lists
NCT02128282 is an interventional study that assigns participants to a tested intervention. The registered 127 participants enrollment target is mid-sized for trials with a published cap, below the 384-participant average among 60 other Cholangiocarcinoma trials with a reported enrollment target (67% lower).
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 lists 16 locations in 7 states (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.
Learn More About Clinical Trials
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Where NCT02128282's enrollment target sits among peer trials
127 28th of 60 higher than 33 of 60 other Cholangiocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cholangiocarcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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