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NCT04645160 · ClinicalTrials.gov registry record · Phase 1
Evaluating Efficacy of Tivozanib (AV-951) in Biliary Tract Cancers
A Phase 1 study of Cholangiocarcinoma and Bile Duct Neoplasm, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
- 1
- Study location
NCT04645160: Recruiting Phase 1 study of Cholangiocarcinoma and Bile Duct Neoplasm, sponsored by National Cancer Institute (NCI).
NCT04645160 is a Phase 1 study of Cholangiocarcinoma and Bile Duct Neoplasm that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 31 participants, below the 385-participant average among 60 other Cholangiocarcinoma trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04645160, a Phase 1 study of Cholangiocarcinoma and Bile Duct Neoplasm, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Cholangiocarcinoma (CCA) is an aggressive cancer of the bile ducts. People with CCA have few treatment options and poor survival. Researchers want to see if a new drug can stop or slow CCA growth. Objective: To find the safest and most effective dose of tivozanib to treat CCA and learn its overall response rate. Eligibility: Adults ages 18 and older with CCA not removable with surgery and have been treated with at least one type of chemotherapy. Design: Participants will be screened with the following: * Medical history * Physical exam * Assessment of their ability to do daily activities * Medicine review * Blood tests, including thyroid function tests * Urine tests * Electrocardiogram, to check heart function * Pregnancy test, if needed * Tumor biopsy, if needed * Computed tomography scans * Magnetic resonance imaging, if needed Some screening tests may be repeated during the study. Participants will be asked to enroll in protocol #13C0176. This will allow any remaining tumor or blood samples to be used in future research. Participants will take tivozanib by mouth, once a day for 21 days per cycle or every other day per cycle. Each cycle is 28 days. They can take the drug until they have bad side effects, their CCA gets worse, or if they become pregnant. They will record their blood pressure twice daily at home. They will also keep a medication diary of each dose of tivozanib they take and any side effects. Participants will have study visits before starting each new cycle and every 8 weeks. They will also have a follow-up visit 30 days after treatment ends at NIH, or if they are unable to come to NIH by phone, videocall, or other NIH-approved platform. Then they will be contacted 6 and 12 months later, and then once a year. ...
Primary Outcome
Patients will be re-evaluated for response every 8 weeks after start of treatment. The Phase II clinical response rate (CR+PR) will be determined and reported along with a 95% confidence interval.
Conditions Studied
Interventions
- DRUG Tivozanib
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2022-03-04 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 1 |
What NCT04645160 shows while recruiting
NCT04645160 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 385-participant average among 60 other Cholangiocarcinoma trials with a reported enrollment target (92% lower).
The record links to 3 conditions, with Cholangiocarcinoma appearing as the primary indexed condition, and to 1 intervention - of which Tivozanib is the first listed.
NCT04645160 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04645160 about?
NCT04645160 is a clinical study titled "Evaluating Efficacy of Tivozanib (AV-951) in Biliary Tract Cancers". Background: Cholangiocarcinoma (CCA) is an aggressive cancer of the bile ducts. People with CCA have few treatment options and poor survival. Researchers want to see if a new drug can stop or slow CCA growth. Objective: To find the safest and most effective dose of tivozanib to treat CCA and lear...
What is the current status of trial NCT04645160?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2022-03-04. Estimated completion is 2027-12-31.
What conditions does trial NCT04645160 study?
This clinical trial studies the following conditions: Cholangiocarcinoma, Bile Duct Neoplasm, Biliary Tract Malignancy.
What interventions are being tested in trial NCT04645160?
The interventions under investigation include: Tivozanib (DRUG).
Who is sponsoring clinical trial NCT04645160?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04645160 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04645160's enrollment target sits among peer trials
31 50th of 60 higher than 11 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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