Clinical trial · Interventional
ZD4054 (Zibotentan) or Placebo Plus Chemotherapy in Patients With Advanced Ovarian Cancer
A Phase II, Double-blind, Placebo-controlled, Multi-centre, Randomised Study of ZD4054 (Zibotentan) Plus Carboplatin and Paclitaxel or Placebo Plus Carboplatin and Paclitaxel in Patients With Advanced Ovarian Cancer Sensitive to Platinum-based Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Primary objective of the trial was not met and so there was no benefit in collecting further information
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Patients With Advanced Ovarian Cancer Sensitive to Platinum-based Chemotherapy | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
| ZD4054 Zibotentan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ZD4054 + paclitaxel + carboplatin
- description
- ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
- interventionNames
- Drug: ZD4054 Zibotentan
- Drug: Paclitaxel
- Drug: Carboplatin
- type
- PLACEBO_COMPARATOR
- label
- Placebo + paclitaxel + carboplatin
- description
- Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
- interventionNames
- Drug: Paclitaxel
- Drug: Carboplatin
- Drug: Placebo
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven diagnosis of: - Epithelial ovarian carcinoma - Fallopian tube carcinoma - Primary serous peritoneal carcinoma * Radiologically documented measurable disease according to RECIST criteria assessed by Computerised Tomography (CT) or Magnetic Resonance Imaging MRI) or radiologically documented non-measurable (but evaluable) disease. * Advanced disease not amenable to curative surgery or radiotherapy at the time of study entry with evidence of disease recurrence or progression at least 6 months following treatment cessation of first-line platinum- containing therapy Exclusion Criteria: * Clinical evidence of central nervous system (CNS) metastases * Non-epithelial ovarian cancer, including malignant mixed Mullerian tumours and mucinous carcinoma of the peritoneum * Tumour of borderline malignancy
References
Publications (1)
- DERIVEDCognetti 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. PMID 23234805