Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations
Public ClinicalTrials.gov record NCT03773302. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3 Multicenter, Open-Label, Randomized, Controlled Study of Oral Infigratinib Versus Gemcitabine With Cisplatin in Subjects With Advanced/Metastatic or Inoperable Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations: The PROOF Trial
Study identification
- NCT ID
- NCT03773302
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- QED Therapeutics, a BridgeBio company
- Industry
- Enrollment
- 48 participants
Conditions and interventions
Conditions
Interventions
- BGJ398 Drug
- Cisplatin Drug
- Gemcitabine Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 26, 2019
- Primary completion
- Mar 1, 2023
- Completion
- Mar 1, 2023
- Last update posted
- May 7, 2024
2019 – 2023
United States locations
- U.S. sites
- 25
- U.S. states
- 14
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Banner MD Anderson Cancer Center | Gilbert | Arizona | 85234 | — |
| University of Arizona | Tucson | Arizona | 85724 | — |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | — |
| St. Joseph Heritage Healthcare | Fullerton | California | 92835 | — |
| USC Norris Cancer Center | Los Angeles | California | 90033 | — |
| University of California Los Angeles | Los Angeles | California | 90095 | — |
| Florida Hospital Medical Group | Orlando | Florida | 32804 | — |
| UF Health Cancer Center at Orlando Health | Orlando | Florida | 32806 | — |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | — |
| University Medical Center - New Orleans | New Orleans | Louisiana | 70112 | — |
| Frederick Regional Healthcare Systems/James M. Stockman Cancer Institute | Frederick | Maryland | 21702 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Barbara Ann Karmanos Cancer Institute - Lawrence and Idell Weisberg Cancer Treatment Center | Detroit | Michigan | 48201 | — |
| Cancer and Hematology Centers of Western Michigan | Grand Rapids | Michigan | 49503 | — |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | — |
| NYU Langone Medical Center | New York | New York | 10016 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10021 | — |
| Levine Cancer Institute - Charlotte | Charlotte | North Carolina | 28204 | — |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45267 | — |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43202 | — |
| Charleston Oncology | Charleston | South Carolina | 29414 | — |
| Parkland Health and Hospital System | Dallas | Texas | 75343 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | — |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Baylor College of Medicine | Houston | Texas | 77096 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 91 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03773302, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 7, 2024 · Synced May 20, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03773302 live on ClinicalTrials.gov.