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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03307148 | Stromal TARgeting for PAncreatic Cancer (STAR_PAC) | PHASE1 | COMPLETED | 29 | — | — | Jan 15, 2016 | Mar 19, 2019 | Jan 22, 2020 | 4 | United Kingdom |
Occurrence of DLT which can be attributed as possibly, probably or definitely related to the study treatment.
Determination of OBD based on serum Vitamin A levels measured at the end of each treatment cycle.
| Arm | Type | Description |
|---|---|---|
| ATRA in combination with Gemcitabine and Nab-Paclitaxel | EXPERIMENTAL | Patients will receive ATRA, Gemcitabine and nab-Paclitaxel in 28 day cycles. ATRA will be administered for 6 cycles whereas Gemcitabine/nab-Paclitaxel will be administered until disease progression. |
| Name | Type | Description |
|---|---|---|
| ATRA | DRUG | Administered orally on D1-15 of each 28 day cycle. |
| Gemcitabine | DRUG | Intravenous Infusion on D1,8 and 15 of each 28 day cycle. |
| Nab-paclitaxel | DRUG | Intravenous Infusion on D1,8 and 15 of each 28 day cycle. |
Inclusion Criteria: Each patient must meet all of the following inclusion criteria to be enrolled in the study: 1. Written informed consent prior to admission to this study 2. Age ≥18 years. No upper age limit. 3. WHO performance status 0 or 1 4. Life expectancy ≥12 weeks 5. Histologically proven ...