drugset / Trial / NCT00939848
Cediranib Versus Placebo Plus Cisplatin/Gemcitabine Chemotherapy for Patients With Advanced Biliary Tract Cancers
RandomizedParallel-groupQuadruple-blindTreatment
Summary
As a result of our previous NCRN study (ABC-02) cisplatin and gemcitabine (CisGem) is likely to become the international standard of care for patients with advanced biliary tract cancer (submitted: ASCO 2009). This study, ABC-03, will determine whether the addition of cediranib(an oral Vascular Endothelial Growth Factor Receptor inhibitor) to CisGem will improve the time to disease progression in this patient group.
Timeline
- Start
- 2011-04
- Primary completion
- 2012-09
- Completion
- 2014-09
Publications
- Lamarca A, Ross P, Wasan HS, Hubner RA, McNamara MG, Lopes A, Palmer DH, Valle JW, Bridgewater J. Advanced extrahepatic cholangiocarcinoma and gallbladder cancer: Post-hoc analysis of the ABC-01, -02 and -03 clinical trials. JHEP Rep. 2026 Mar 24;8(7):101833. doi: 10.1016/j.jhepr.2026.101833. Online ahead of print.
- Valle JW, Wasan H, Lopes A, Backen AC, Palmer DH, Morris K, Duggan M, Cunningham D, Anthoney DA, Corrie P, Madhusudan S, Maraveyas A, Ross PJ, Waters JS, Steward WP, Rees C, Beare S, Dive C, Bridgewater JA. Cediranib or placebo in combination with cisplatin and gemcitabine chemotherapy for patients with advanced biliary tract cancer (ABC-03): a randomised phase 2 trial. Lancet Oncol. 2015 Aug;16(8):967-78. doi: 10.1016/S1470-2045(15)00139-4. Epub 2015 Jul 12.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cediranib | Small molecule | 20 mg | Oral |
| Background | Cisplatin | Other / unclassified | 25 mg/m2 | — |
| Background | Gemcitabine | Small molecule | 1000 mg/m2 | — |