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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04257448 | Safety and Tolerance of Epigenetic and Immunomodulating Drugs Combined With Chemotherapeutics in Patients Suffering From Advanced Pancreatic Cancer | PHASE1 | COMPLETED | 75 | — | — | May 25, 2020 | Jul 2, 2024 | Sep 30, 2025 | 9 | Germany |
Dose limiting toxicities occurring during treatment cycle 1 of a respective dose level and regarded to be related to the studied drug combination. Common terminology criteria for adverse events (CTCAE) 5.0 will be used to assess toxicities.
The efficacy and safety of this experimental (immune) consolidation therapy during this clinical trial will be monitored by imaging changes every 8 weeks.
Identification of the recommended dose for expansion of Azacitidine and/or Romidepsin in combination with nab-Paclitaxel/Gemcitabine.
| Arm | Type | Description |
|---|---|---|
| Romidepsin/nab-Paclitaxel/Gemcitabine (Arm A) | EXPERIMENTAL | Part 1a: Romidepsin (2 mg/m² or 3.3 mg/m² or 7 mg/m²) will be administered in combination with nab-Paclitaxel (125 mg/m²)/Gemcitabine (1000 mg/m²) on Day 1, Day 8 and Day 15 (every 28 days) of each treatment cycle. Study treatment is given until intolerable toxicity or will escalate until the recommended dose for expansion for a maximum of 3 cycles. |
| Azacitidine/nab-Paclitaxel/Gemcitabine (Arm B) | EXPERIMENTAL | Part 1a: Azacitidine (20 mg/m² or 30 mg/m² or 40 mg/m²) will be administered on Days -7 to Day -3 of each treatment cycle. Additionally nab-Paclitaxel (125 mg/m²)/Gemcitabine (1000 mg/m²) will be given on Day 1, Day 8 and Day 15 (every 28 days) of each treatment cycle. Study treatment is given until intolerable toxicity or will escalate until the recommended dose for expansion for a maximum of 3 cycles. |
| Romidepin/Azacitidine/nab-Paclitaxel/Gemcitabine (Arm C) | EXPERIMENTAL | Part 1a: The intervention to be administered depends on the determined dose in Arm A and Arm B. Additionally nab-Paclitaxel (125 mg/m²)/Gemcitabine (1000 mg/m²) will be given on Day 1, Day 8 and Day 15 (every 28 days) of each treatment cycle. Study treatment is given until intolerable toxicity or will escalate until the recommended dose for expansion for a maximum of 3 cycles. |
| nab-Paclitaxel/Gemcitabine (Standard Arm) | ACTIVE_COMPARATOR | nab-Paclitaxel (125 mg/m²)/Gemcitabine (1000 mg/m²) will be administered on Day 1, Day 8 and Day 15 (every 28 days) of each treatment cycle. |
| Arm C or B or A | EXPERIMENTAL | In Part 1b (expansion part) of the study, one of the treatment arms (Arm C over Arm B over Arm A) will be continued. Treatment will only be performed with the study drug that were tolerable in Part 1a (dose escalation). |
| Durvalumab/Lenalidomide | EXPERIMENTAL | Part 2: All patients from Part 1 who have not progressed after three cycles receive standard fixed dose Durvalumab (1500 mg) on Day 1 of each 28-day treatment cycle by IV infusion in combination with orally administered low-dose Lenalidomide (10 mg) on Days 1 to 21 until documented disease progression. Study treatment is given for a maximum of 13 cycles. |
| Name | Type | Description |
|---|---|---|
| Romidepsin | DRUG | Powder and solvent for solution for infusion; Intravenous use |
| Azacitidine | DRUG | Powder for suspension for injection; Subcutaneous use |
| nab-Paclitaxel | DRUG | Powder for suspension for injection; Intravenous use |
| Gemcitabine | DRUG | Powder for solution for infusion; Intravenous use |
| Durvalumab | DRUG | Concentrate for solution for infusion; Intravenous use |
| Lenalidomide capsule | DRUG | Hard capsule for oral use |
Inclusion Criteria: * Patients must have histologically confirmed PDAC * Patients must have metastatic disease (stage IV) and not received prior chemotherapy for stage IV disease * Patients must not have received the following drugs before: Azacitidine, Romidepsin, any checkpoint-inhibitor or immun...