Trial · NCT04257448
Safety and Tolerance of Epigenetic and Immunomodulating Drugs Combined With Chemotherapeutics in Patients Suffering From Advanced Pancreatic Cancer
NCT04257448, Phase 1, Phase 2, Completed, GWT-TUD GmbH
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Tolerance of Epigenetic and Immunomodulating Drugs Combined With Chemotherapeutics in Patients Suffering From Advanced Pancreatic Cancer. Trials, record NCT04257448. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04257448
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Tolerance of Epigenetic and Immunomodulating Drugs Combined With Chemotherapeutics in Patients Suffering From Advanced Pancreatic Cancer
- NCT number
- NCT04257448
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 75 participants, actual
- Lead sponsor
- GWT-TUD GmbH
- Conditions
- Pancreas Cancer, Pancreatic Adenocarcinoma, Pancreatic Ductal Adenocarcinoma
- Interventions
- Romidepsin, Azacitidine, nab-Paclitaxel, Gemcitabine, Durvalumab, Lenalidomide capsule
- First posted
- 2020-02-06
- Last updated
- 2025-09-30
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety and tolerability of Azacitidine and/or Romidepsin in combination with nab-Paclitaxel/Gemcitabine | at Days -7, -4, 1, 8, 15, 22 at cycle 1 (each cycle is 28 days) | 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. |
| Primary | Immune targeting with Durvalumab in combination with low-dose Lenalidomide | up to 13 cycles (each cycle is 28 days) | The efficacy and safety of this experimental (immune) consolidation therapy during this clinical trial will be monitored by imaging changes every 8 weeks. |
| Primary | Immune targeting with Durvalumab in combination with low-dose Lenalidomide | up to 13 cycles (each cycle is 28 days) | The efficacy and safety of this experimental (immune) consolidation therapy during this clinical trial will be monitored closely by tumor marker changes on Day 1 of each cycle. |
| Primary | Recommended dose for expansion (RDE) | at the end of cycle 3 (each cycle is 28 days) | Identification of the recommended dose for expansion of Azacitidine and/or Romidepsin in combination with nab-Paclitaxel/Gemcitabine. |
| Secondary | Overall response rate (ORR) | up to 16 months | Part 1: ORR according to RECIST version 1.1 (complete response \[CR\] and partial response \[PR\]) after respective treatment) every 6 weeks Part 2: ORR according to immune related RECIST 1.1 (irRECIST1.1) (CR and PR) after/during treatment with Lenalidomide and Durvalumab every 8 weeks |
| Secondary | Carbohydrate Antigen 19-9 (CA19-9) Response | at Day 1 of each treatment cycle (each cycle is 28 days), up to 16 month | Part 1: CA19-9 Response: CA19 -9 change after treatment compared to baseline level Part 2: 2nd CA19-9 Response: CA19 -9 change after treatment compared to last level determined in Part 1 |
| Secondary | Disease-control rate (DCR) | at the end of cycle 3 and 6 (each cycle is 28 days) | Part 1: DCR at 3-month according to RECIST version 1.1 (CR and PR and stable disease \[SD\] after respective treatment Part 2: 2nd DCR at 3-month and 6-month according to irRECIST1.1 (CR and PR and stable disease \[SD\] after respective treatment) |
| Secondary | Overall survival (OS) | at Day 1 of cycle 1 (each cycle is 28 days) until death or up to 4 years | Time from Day 1 of the first cycle of chemotherapy to date of death from any cause. The rate of patients who are still alive after one year will be assessed. |
| Secondary | Progression free survival (PFS) | D1 of the first cycle (each cycle is 28 days), up to 16 month | Time from Day 1 of the first cycle of chemotherapy to date of objective disease progression or to death of any cause. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04257448
GET https://conductscience.org/api/trials/v1/NCT04257448/registered