drugset / Trial / NCT01373164
A Study in Metastatic Cancer and Advanced or Metastatic Unresectable Pancreatic Cancer
Non-randomizedParallel-groupOpen-labelTreatment
Summary
Phase 1b: To determine the safe and tolerable dose of galunisertib in combination with gemcitabine in patients with solid malignancy Phase 2a: To compare the overall survival (OS) of patients with Stage II to IV unresectable pancreatic cancer when treated with a combination of galunisertib and gemcitabine with that of gemcitabine plus placebo.
Timeline
- Start
- 2011-06
- Primary completion
- 2015-11
- Completion
- 2016-12
Publications
- Smith CL, Thomas Z, Enas N, Thorn K, Lahn M, Benhadji K, Cleverly A. Leveraging historical data into oncology development programs: Two case studies of phase 2 Bayesian augmented control trial designs. Pharm Stat. 2020 May;19(3):276-290. doi: 10.1002/pst.1990. Epub 2020 Jan 5.
- Melisi D, Garcia-Carbonero R, Macarulla T, Pezet D, Deplanque G, Fuchs M, Trojan J, Kozloff M, Simionato F, Cleverly A, Smith C, Wang S, Man M, Driscoll KE, Estrem ST, Lahn MMF, Benhadji KA, Tabernero J. TGFbeta receptor inhibitor galunisertib is linked to inflammation- and remodeling-related proteins in patients with pancreatic cancer. Cancer Chemother Pharmacol. 2019 May;83(5):975-991. doi: 10.1007/s00280-019-03807-4. Epub 2019 Mar 18.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Galunisertib | Small molecule | 40 mg | Oral |
| Subject | Galunisertib | Small molecule | 80 mg | Oral |
| Subject | Galunisertib | Small molecule | 150 mg | Oral |
| Subject | Galunisertib | Small molecule | 300 mg | Oral |
| Subject | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |