18 and older, any sex, with Pancreatic Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With a Dose-limiting Toxicity (DLT)Primary· 28 days
Toxicities were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), V 3.0. A DLT was one of the following, if considered at least possibly related to study treatment:
Grade 4 neutropenia for ≥5 days or febrile neutropenia; Grade 4 thrombocytopenia or need for a platelet transfusion; ≥ Grade 3 nausea and/or emesis despite using optimal antiemetic therapy; ≥ Grade 3 diarrhea despite using maximal supportive therapy; Any clinically significant Grade 3 or 4 nonhematologic toxicity; Inability to administer all doses in cycle 1.
Group
Value
95% CI
Dose Level 1
3
Dose Level 2
1
Dose Level 5
0
Dose Level 6
2
Dose Level 8
0
Number of Participants With Adverse Events (AEs)Primary· From the date of first dose to 30 days after last dose (up to 236 days).
AEs were graded for severity according to the National Cancer Institute Common Terminology Criteria (NCI CTCAE), V 3.0: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe (prevents normal everyday activities); Grade 4: Life-threatening or disabling; Grade 5: Death.
A serious AE is associated with events that pose a threat to a patient's life or functioning, require hospitalization, is a congenital anomaly/birth defect or is an important medical event or condition that may jeopardize the patient and may require medical or surgical intervention to prevent one of the above outcomes.
Any adverse event
Group
Value
95% CI
Dose Level 1
7
Dose Level 2
7
Dose Level 5
10
Dose Level 6
6
Dose Level 8
6
≥Grade 3 adverse event
Group
Value
95% CI
Dose Level 1
7
Dose Level 2
5
Dose Level 5
5
Dose Level 6
4
Dose Level 8
3
Grade 4 adverse event
Group
Value
95% CI
Dose Level 1
1
Dose Level 2
2
Dose Level 5
3
Dose Level 6
2
Dose Level 8
1
Serious adverse event
Group
Value
95% CI
Dose Level 1
3
Dose Level 2
2
Dose Level 5
4
Dose Level 6
1
Dose Level 8
2
Adverse event leading to discontinuation
Group
Value
95% CI
Dose Level 1
0
Dose Level 2
0
Dose Level 5
1
Dose Level 6
0
Dose Level 8
1
Adverse event leading to death
Group
Value
95% CI
Dose Level 1
0
Dose Level 2
0
Dose Level 5
0
Dose Level 6
0
Dose Level 8
1
Best Overall ResponsePrimary· Disease assessments were performed within 4 weeks of first dose and every 8 weeks thereafter (up to 236 days).
Disease response was determined by the Investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria using computed tomography or magnetic resonance imaging:
Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions or the appearance of ≥1 new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Complete Response
Group
Value
95% CI
Dose Level 1
0
Dose Level 2
0
Dose Level 5
0
Dose Level 6
0
Dose Level 8
0
Partial Response
Group
Value
95% CI
Dose Level 1
0
Dose Level 2
1
Dose Level 5
0
Dose Level 6
0
Dose Level 8
1
Stable disease
Group
Value
95% CI
Dose Level 1
5
Dose Level 2
4
Dose Level 5
3
Dose Level 6
1
Dose Level 8
1
Progressive disease
Group
Value
95% CI
Dose Level 1
1
Dose Level 2
2
Dose Level 5
4
Dose Level 6
3
Dose Level 8
1
Adverse events — posted to ClinicalTrials.gov
Time frame: From the date of first dose to 30 days after last dose..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This was a phase I dose escalation trial designed to determine the maximum tolerated dose (MTD) for the combination of romidepsin (depsipeptide) and gemcitabine. The study was originally planned as a Phase I/II; however only Phase I of the study was conducted.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04639843 — Doxorubicin, CC-(486) (5-azacitidine), Romidepsin, and Duvelisib (hARD) for T-cell Lymphoma
· Phase 1
· withdrawn
NCT04774068 — Romidepsin and Parsaclisib for the Treatment of Relapsed or Refractory T-Cell Lymphomas
· Phase 1
· completed
NCT04747236 — Randomized Phase IIB Trial of Oral Azacytidine Plus Romidepsin Versus Investigator's Choice in PTCL
· Phase 2
· recruiting
NCT04447027 — Romidepsin, CC-486 (5-azacitidine), Dexamethasone, and Lenalidomide (RAdR) for Relapsed/Refractory T-cell Malignancies
· Phase 1
· completed
NCT04257448 — Safety and Tolerance of Epigenetic and Immunomodulating Drugs Combined With Chemotherapeutics in Patients Suffering From
· Phase 1, PHASE2
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Celgene
Last refreshed: 30 October 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00379639.