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NCT04331041 · ClinicalTrials.gov registry record · Phase 2
Stereotactic Body Radiotherapy and Focal Adhesion Kinase Inhibitor in Advanced Pancreas Adenocarcinoma
A Phase 2 study of Pancreas Cancer and Pancreas Adenocarcinoma, sponsored by Washington University School of Medicine.
- Active
- Registry status
- Phase 2
- Development phase
- 42
- Enrollment target
- 1
- Study location
NCT04331041: Active Phase 2 study of Pancreas Cancer and Pancreas Adenocarcinoma, sponsored by Washington University School of Medicine.
NCT04331041 is a Phase 2 study of Pancreas Cancer and Pancreas Adenocarcinoma that is active but no longer recruiting, run by Washington University School of Medicine. The registered enrollment target is 42 participants, below the 907-participant average among 54 other Pancreas Cancer trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04331041, a Phase 2 study of Pancreas Cancer and Pancreas Adenocarcinoma, is active but no longer recruiting, sponsored by Washington University School of Medicine.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 42 participants
- Enrollment target
- 1
- Study location
Study Summary
Patients with advanced pancreas adenocarcinoma will be randomized on a 6:1 basis to receive standard of care chemotherapy followed by adaptive stereotactic body radiotherapy (SBRT) with concurrent and adjuvant FAK inhibitor defactinib (experimental arm) or standard of care chemotherapy followed by SBRT (control arm). Patients enrolled to the experimental arm will be assessed for clinical outcomes such as progression free survival (PFS), local control, distant control, and toxicity. The initial 6 patients randomized to the experimental arm will be considered the safety lead-in and will be assessed for dose-limiting toxicities (DLTs). Following completion of the safety lead-in, additional patients will be accrued in order to reach a total of 36 patients on the experimental arm (inclusive of the safety lead-in cohort) and 6 on the control arm.
Primary Outcome
* PFS is defined as the duration of time from start of standard of care chemotherapy treatment to time of progression or death, whichever occurs first. The alive patients without progression will be censored at the last follow-up. * Progressive disease: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also
Conditions Studied
Interventions
- DRUG Defactinib
- PROCEDURE Tumor biopsy
- DEVICE Adaptive stereotactic body radiation therapy
- PROCEDURE Research blood draw
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2021-08-24 |
| Est. Completion | 2027-04-21 |
| Phase | Phase 2 |
What the registry record for NCT04331041 still lists
NCT04331041 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 907-participant average among 54 other Pancreas Cancer trials with a reported enrollment target (95% lower).
The record links to 3 conditions, with Pancreas Cancer appearing as the primary indexed condition, and to 4 interventions - of which Defactinib is the first listed.
NCT04331041 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT04331041 about?
NCT04331041 is a clinical study titled "Stereotactic Body Radiotherapy and Focal Adhesion Kinase Inhibitor in Advanced Pancreas Adenocarcinoma". Patients with advanced pancreas adenocarcinoma will be randomized on a 6:1 basis to receive standard of care chemotherapy followed by adaptive stereotactic body radiotherapy (SBRT) with concurrent and adjuvant FAK inhibitor defactinib (experimental arm) or standard of care chemotherapy followed by S...
What is the current status of trial NCT04331041?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2021-08-24. Estimated completion is 2027-04-21.
What conditions does trial NCT04331041 study?
This clinical trial studies the following conditions: Pancreas Cancer, Pancreas Adenocarcinoma, Cancer of the Pancreas.
What interventions are being tested in trial NCT04331041?
The interventions under investigation include: Defactinib (DRUG), Tumor biopsy (PROCEDURE), Adaptive stereotactic body radiation therapy (DEVICE), Research blood draw (PROCEDURE).
Who is sponsoring clinical trial NCT04331041?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04331041 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04331041's enrollment target sits among peer trials
42 33rd of 54 higher than 22 of 54 other Pancreas Cancer trials
participants (enrollment target), bucketed by value
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