drugset / Trial / NCT01893801
Nab-Pac+Cis+Gem in Pts w Previously Untreated Metastatic PDA
Phase 1/2
Completed
25 enrolled
Pancreatic Cancer Research Team
Cancer Research and Biostatistics Clinical Trials Consortium · collabHonor Health - Clinical Trials · collabTranslational Genomics Research Institute · collab
NaSingle-groupOpen-labelTreatment
Summary
The primary objective of this study is to determine the efficacy of nab-paclitaxel plus cisplatin plus gemcitabine for patients with metastatic pancreatic ductal adenocarcinoma (PDA).
Timeline
- Start
- 2013-05
- Primary completion
- 2016-04
- Completion
- 2017-10-01
Outcome
Missed primary endpoint
paper The RECIST responses in 24 evaluable patients included 2 complete responses (8%), which was below the primary end point of 25%, PMID 31580386 ↗
paper Although the primary end point was not reached, PMID 31580386 ↗
Publications
- Background Von Hoff DD, Ramanathan RK, Borad MJ, Laheru DA, Smith LS, Wood TE, Korn RL, Desai N, Trieu V, Iglesias JL, Zhang H, Soon-Shiong P, Shi T, Rajeshkumar NV, Maitra A, Hidalgo M. Gemcitabine plus nab-paclitaxel is an active regimen in patients with advanced pancreatic cancer: a phase I/II trial. J Clin Oncol. 2011 Dec 1;29(34):4548-54. doi: 10.1200/JCO.2011.36.5742. Epub 2011 Oct 3.
- Background 2013 Gastrointestinal Cancers Symposium. Abstract LBA148. Presented January 25, 2013
- Jameson GS, Borazanci E, Babiker HM, Poplin E, Niewiarowska AA, Gordon MS, Barrett MT, Rosenthal A, Stoll-D'Astice A, Crowley J, Shemanski L, Korn RL, Ansaldo K, Lebron L, Ramanathan RK, Von Hoff DD. Response Rate Following Albumin-Bound Paclitaxel Plus Gemcitabine Plus Cisplatin Treatment Among Patients With Advanced Pancreatic Cancer: A Phase 1b/2 Pilot Clinical Trial. JAMA Oncol. 2020 Jan 1;6(1):125-132. doi: 10.1001/jamaoncol.2019.3394.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 25 mg/m2 | Intravenous |
| Subject | Cisplatin | Other / unclassified | 37.5 mg/m2 | Intravenous |
| Subject | Cisplatin | Other / unclassified | 50 mg/m2 | Intravenous |
| Subject | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Subject | Nab-paclitaxel | Small molecule | 25 mg/m2 | Intravenous |