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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03126435 | EndoTAG-1+GEM vs GEM in Patients With Locally Advanced/Metastatic Pancreatic Adenocarcinoma Failed on FOLFIRINOX | PHASE3 | COMPLETED | 218 | — | — | Oct 16, 2018 | Oct 8, 2021 | May 6, 2023 | 68 | United States, France +5 |
The efficacy of EndoTAG-1 treatment was demonstrated through number of events, meaning subject death, compared to number of subjects censored at the time of analysis.
| Arm | Type | Description |
|---|---|---|
| EndoTAG-1 and Gemcitabine | EXPERIMENTAL | EndoTAG-1 22 mg/m² twice weekly plus Gemcitabine 1000mg/m² once weekly for 1 cycle (8 weeks) consisting of 3 weeks of treatment and 1 week rest followed by 3 weeks of treatment and 1 week rest until any one of the following occurs: progressive disease or unacceptable toxicity or withdrawal of consent. |
| Gemcitabine Monotherapy | ACTIVE_COMPARATOR | Gemcitabine 1000mg/m² once weekly, for 1 cycle (8 weeks) consisting of 3 weeks of treatment and 1 week rest followed by 3 weeks of treatment and 1 week rest until any one of the following occurs: progressive disease or unacceptable toxicity or withdrawal of consent. |
| Name | Type | Description |
|---|---|---|
| EndoTAG-1 | DRUG | twice weekly |
| Gemcitabine | DRUG | once weekly |
Inclusion Criteria: 1. Age ≥ 18 years 2. Written informed consent 3. Histologically or cytologically confirmed adenocarcinoma of the pancreas 4. Metastatic or locally advanced disease that is considered unresectable 5. Measurable / assessable disease according to RECIST v.1.1 6. Documented disease ...