ZD4054 (Zibotentan) or Placebo Plus Chemotherapy in Patients With Advanced Ovarian Cancer

Summary

The purpose of this study is to compare progression-free survival in patients with advanced ovarian cancer treated with ZD4054 in combination with carboplatin+paclitaxel versus placebo in combination with carboplatin+paclitaxel.

Timeline

Start

2009-06

Primary completion

2011-06

Completion

2011-06

Outcome

Missed primary endpoint

Stopped: “Primary objective of the trial was not met and so there was no benefit in collecting further information”

paper Addition of zibotentan 10mg/day to carboplatin and paclitaxel did not improve PFS compared with placebo PMID 23234805 ↗

paper P=0.0870 PMID 23234805 ↗

Publications

• Cognetti F, Bagnato A, Colombo N, Savarese A, Scambia G, Sehouli J, Wimberger P, Sorio R, Harter P, Mari E, McIntosh S, Nathan F, Pemberton K, Baumann K. A Phase II, randomized, double-blind study of zibotentan (ZD4054) in combination with carboplatin/paclitaxel versus placebo in combination with carboplatin/paclitaxel in patients with advanced ovarian cancer sensitive to platinum-based chemotherapy (AGO-OVAR 2.14). Gynecol Oncol. 2013 Jul;130(1):31-7. doi: 10.1016/j.ygyno.2012.12.004. Epub 2012 Dec 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Zibotentan	Small molecule	10 mg	Oral
Background	Carboplatin	Small molecule	—	Intravenous
Background	Paclitaxel	Small molecule	175 mg/m2	Intravenous

Indications

No indication recorded.