A Phase 2 interventional study of ZD4054 Zibotentan and Paclitaxel in Patients With Advanced Ovarian Cancer Sensitive to Platinum-based Chemotherapy, sponsored by AstraZeneca. Terminated at 20 sites in 2 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-08-07.
Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment
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.
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's enrollment of 120 is above the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
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Exclusion Criteria:
ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
Drug: ZD4054 Zibotentan · Drug: Paclitaxel · Drug: Carboplatin
Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
Drug: Paclitaxel · Drug: Carboplatin · Drug: Placebo
10 mg oral tablets once daily
175mg/m2 IV on day 1 every 3 weeks
Carboplatin AUC of 5.0 IV on day 1 every 3 weeks
matching placebo for ZD4054 10 mg
Progression Free Survival
Median time (in months) from randomisation until clinical progression of disease using the Kaplan-Meier method.
Time frame: Patients were followed for progression up to 2 years
Overall Survival
Median time (in months) from randomisation until death using the Kaplan-Meier method.
Time frame: Patients were followed for survival up to 2 years
Tumour Response Rate
Objective response rate defined as participants with a complete or partial response according to RECIST
Time frame: While receiving paclitaxel + carboplatin study visits were aliged with its administration ie every 3 weeks, then every 6 weeks (up to 2 years)
132 patients with advanced ovarian cancer sensitive to platinum-based chemotherapy were recruited between 26th June 2009 and 1st June 2011.
| Milestone | ZD4054+Paclitaxel+Carboplatin | Placebo+Paclitaxel+Carboplatin |
|---|---|---|
| Started | 59 | 61 |
| Patients who received treatment | 58 | 58 |
| Completed | 11 | 19 |
| Not completed | 48 | 42 |
| Withdrew: Adverse event | 8 | 5 |
| Withdrew: Withdrawal by subject | 3 | 1 |
| Withdrew: Protocol violation | 32 | 30 |
| Withdrew: Other termination reason | 5 | 6 |
Median time (in months) from randomisation until clinical progression of disease using the Kaplan-Meier method.
| Months | ZD4054+Paclitaxel+Carboplatin | Placebo+Paclitaxel+Carboplatin |
|---|---|---|
| Progression Free Survival | 7.6 (6.6 to 10.2) | 10.0 (7.1 to 12.2) |
Median time (in months) from randomisation until death using the Kaplan-Meier method.
No measurements were reported for this outcome.
Objective response rate defined as participants with a complete or partial response according to RECIST
| Participants | ZD4054+Paclitaxel+Carboplatin | Placebo+Paclitaxel+Carboplatin |
|---|---|---|
| Tumour Response Rate | 21 | 34 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ZD4054+Paclitaxel+Carboplatin | — | 19/58 (32.8%) | 57/58 (98.3%) |
| Placebo+Paclitaxel+Carboplatin | — | 13/58 (22.4%) | 58/58 (100%) |
| Event | ZD4054+Paclitaxel+Carboplatin | Placebo+Paclitaxel+Carboplatin |
|---|---|---|
| Drug HypersensitivityImmune system disorders | 5/58 | 4/58 |
| Abdominal PainGastrointestinal disorders | 4/58 | 1/58 |
| SubileusGastrointestinal disorders | 4/58 | 0/58 |
| IleusGastrointestinal disorders | 3/58 | 0/58 |
| ConstipationGastrointestinal disorders | 2/58 | 1/58 |
| PyrexiaGeneral disorders | 0/58 | 2/58 |
| AnaemiaBlood and lymphatic system disorders | 1/58 | 0/58 |
| Coronary Artery OcclusionCardiac disorders | 0/58 | 1/58 |
| Ischaemic CardiomyopathyCardiac disorders | 0/58 | 1/58 |
| AscitesGastrointestinal disorders | 1/58 | 1/58 |
| Event | ZD4054+Paclitaxel+Carboplatin | Placebo+Paclitaxel+Carboplatin |
|---|---|---|
| NauseaGastrointestinal disorders | 28/58 | 31/58 |
| AnaemiaBlood and lymphatic system disorders | 30/58 | 25/58 |
| AlopeciaSkin and subcutaneous tissue disorders | 28/58 | 28/58 |
| FatigueGeneral disorders | 20/58 | 27/58 |
| HeadacheNervous system disorders | 27/58 | 17/58 |
| NeutropeniaBlood and lymphatic system disorders | 26/58 | 22/58 |
| ConstipationGastrointestinal disorders | 24/58 | 19/58 |
| VomitingGastrointestinal disorders | 21/58 | 20/58 |
| LeukopeniaBlood and lymphatic system disorders | 20/58 | 15/58 |
| Abdominal PainGastrointestinal disorders | 16/58 | 20/58 |
| Age Continuous(Years) | ZD4054+Paclitaxel+Carboplatin | Placebo+Paclitaxel+Carboplatin | Total |
|---|---|---|---|
| Overall | 57.4 ± 11.98 | 56.6 ± 11.07 | 57.0 ± 11.49 |
| Sex: Female, Male(Participants) | ZD4054+Paclitaxel+Carboplatin | Placebo+Paclitaxel+Carboplatin | Total |
|---|---|---|---|
| Female | 59 | 61 | 120 |
| Male | 0 | 0 | 0 |
This study is terminated, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.
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