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NCT04301778 · ClinicalTrials.gov registry record · Phase 2
Durvalumab and SNDX-6532 Following Chemo or Radio-Embolization for Patients With Intrahepatic Cholangiocarcinoma
A Phase 2 study of Unresectable Intrahepatic Cholangiocarcinoma, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Completed
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
- 1
- Study location
NCT04301778: Completed Phase 2 study of Unresectable Intrahepatic Cholangiocarcinoma, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT04301778 is a Phase 2 study of Unresectable Intrahepatic Cholangiocarcinoma that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 5 participants, below the 35-participant average among 3 other Unresectable Intrahepatic Cholangiocarcinoma trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04301778, a Phase 2 study of Unresectable Intrahepatic Cholangiocarcinoma, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
- 1
- Study location
Study Summary
The purposed of this research is to study the safety and clinical activity of the combination of durvalumab and a CSF-1R inhibitor (SNDX-6352) in people with Intrahepatic Cholangiocarcinoma.
Primary Outcome
ORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on the Response Evaluation Criteria in Solid Tumors (mRECIST) at any time during the study. CR = disappearance of all target lesions, PR is =\>30% decrease in sum of diameters of target lesions, progressive disease (PD) is \>20% increase in sum of diameters of target lesions, stable disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions. Estimation based on t
Conditions Studied
Interventions
- DRUG Durvalumab
- DRUG SNDX-6352
Study Locations (1)
Maryland
- Sidney Kimmel Comprehensive Cancer Center - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2021-08-24 |
| Est. Completion | 2024-02-06 |
| Phase | Phase 2 |
What the finished NCT04301778 record still lists
NCT04301778 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 35-participant average among 3 other Unresectable Intrahepatic Cholangiocarcinoma trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Unresectable Intrahepatic Cholangiocarcinoma appearing as the primary indexed condition, and to 2 interventions - of which Durvalumab is the first listed.
NCT04301778 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04301778 about?
NCT04301778 is a clinical study titled "Durvalumab and SNDX-6532 Following Chemo or Radio-Embolization for Patients With Intrahepatic Cholangiocarcinoma". The purposed of this research is to study the safety and clinical activity of the combination of durvalumab and a CSF-1R inhibitor (SNDX-6352) in people with Intrahepatic Cholangiocarcinoma.
What is the current status of trial NCT04301778?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2021-08-24. Estimated completion is 2024-02-06.
What conditions does trial NCT04301778 study?
This clinical trial studies the following conditions: Unresectable Intrahepatic Cholangiocarcinoma.
What interventions are being tested in trial NCT04301778?
The interventions under investigation include: Durvalumab (DRUG), SNDX-6352 (DRUG).
Who is sponsoring clinical trial NCT04301778?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04301778 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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