Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04331041 | Stereotactic Body Radiotherapy and Focal Adhesion Kinase Inhibitor in Advanced Pancreas Adenocarcinoma | PHASE2 | ACTIVE NOT_RECRUITING | 42 | — | — | Aug 24, 2021 | Apr 21, 2027 | May 8, 2026 | 1 | United States |
* 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 demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
| Arm | Type | Description |
|---|---|---|
| Adaptive SBRT + Defactinib | EXPERIMENTAL | * Participants in this study will receive 5 fractions of magnetic resonance adaptive stereotactic body radiation therapy (SBRT) and seventeen 21-day cycles of defactinib (beginning on Day 2 of radiation). * Participants who are candidates for surgical resection will undergo standard of care surgery at 2 weeks post-end of SBRT (+/- 1 weeks) or 12 weeks post-end of SBRT (+/- 1 week). These participants will discontinue defactinib the day prior to the operation and will resume taking it for the remainder of the 17 cycles 4 to 6 weeks after surgery. Participants who are not candidates for surgical resection will continue to receive defactinib uninterrupted. All participants should receive 17 cycles of defactinib unless they experience disease progression or intolerable toxicity. |
| Adaptive SBRT | ACTIVE_COMPARATOR | -Participants in this study will receive 5 fractions of magnetic resonance adaptive stereotactic body radiation therapy (SBRT) |
| Name | Type | Description |
|---|---|---|
| Adaptive stereotactic body radiation therapy | DEVICE | * Will be administered using MRIdian and Ethos * 50 Gy in 5 fractions |
| Defactinib | DRUG | -Oral drug 400 mg twice a day |
| Tumor biopsy | PROCEDURE | -Baseline and 12-14 weeks after end of SBRT (or at time of surgery) |
| Research blood draw | PROCEDURE | -Baseline, 6-8 weeks after the end of SBRT, and 12-14 weeks after the end of SBRT |
Inclusion Criteria: * Histologically or cytologically confirmed locally advanced pancreas adenocarcinoma that is considered borderline resectable or unresectable per institutional standardized criteria of unresectability or medical inoperability (NCCN guidelines 2.2021 PANC-C 1 of 2). * Patients wi...