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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03189914 | RX-3117 in Combination With Abraxane® in Subjects With Metastatic Pancreatic Cancer | PHASE1 | COMPLETED | 46 | — | — | Oct 2, 2017 | Nov 21, 2019 | Dec 6, 2023 | 10 | United States |
Number of participants who experienced a treatment-related adverse event
Participants with adverse events coded using the MedDRA Dictionary (Version 20.0) to Investigations. Due to the underlying disease, not all abnormal labs are reported.
Number of participants with clinically significant vital sign abnormalities (Phase 1 and 2) including heart rate, respiration rate, and blood pressure
Number of participants with clinically significant ECG abnormalities (Phase 1 and 2)
Participants must have progression Free Survival (PFS) \> 4 months or objective clinical response (complete or partial response).
| Arm | Type | Description |
|---|---|---|
| RX-3117 + Abraxane | EXPERIMENTAL | RX-3117: oral, 500 - 700 mg/ day for 5 days on/ 2 days off for 3 weeks. 1 washout week/ cycle. Abraxane: 75 - 125 mg/m\^2, infused once per week for 3 weeks. 1 washout week/ cycle. |
| Name | Type | Description |
|---|---|---|
| RX-3117 | DRUG | RX-3117 will be administered orally in combination with Abraxane. |
Inclusion Criteria: Disease Related 1. Subject has confirmed histologic or cytologic evidence of metastatic pancreatic cancer and has no prior treatment for metastatic pancreatic cancer. 2. Subject has measurable disease using Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1. 3. Subject...