Trial to Improve Outcomes in Patients With Resected Pancreatic Cancer (Azacitidine)

Summary

To improve progression free survival in high risk patients with resected pancreatic adenocarcinoma who have node positive disease, margin positive disease, and/or elevation in CA 19-9 treated with CC-486 (oral azacitidine) as compared to observation after completion of adjuvant therapy.

Timeline

Start

2014-01-10

Primary completion

2021-04-09

Completion

2021-04-09

Outcome

Missed primary endpoint

paper Median PFS in imagining-confirmed cases was 9.2 and 8.9mo (HR 0.94, 95% CI 0.46-1.87, p = 0.85) for CC-486 and OBS patients, respectively. PMID 36463226 ↗

paper Treatment with CC-486 following adjuvant therapy did not prolong time-to-relapse in patients with high-risk rPDA PMID 36463226 ↗

Publications

• Tost J, Ak-Aksoy S, Campa D, Corradi C, Farinella R, Ibanez-Costa A, Dubrot J, Earl J, Melian EB, Kataki A, Kolnikova G, Madjarov G, Chaushevska M, Strnadel J, Tanic M, Tomas M, Dubovan P, Urbanova M, Buocikova V, Smolkova B. Leveraging epigenetic alterations in pancreatic ductal adenocarcinoma for clinical applications. Semin Cancer Biol. 2025 Feb;109:101-124. doi: 10.1016/j.semcancer.2025.01.003. Epub 2025 Jan 23.
• Heumann TR, Baretti M, Sugar EA, Durham JN, Linden S, Lopez-Vidal TY, Leatherman J, Cope L, Sharma A, Weekes CD, O'Dwyer PJ, Reiss KA, Monga DK, Ahuja N, Azad NS. A randomized, phase II trial of oral azacitidine (CC-486) in patients with resected pancreatic adenocarcinoma at high risk for recurrence. Clin Epigenetics. 2022 Dec 3;14(1):166. doi: 10.1186/s13148-022-01367-8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Azacitidine	Other / unclassified	300 mg	Oral

Indications