Patients With Advanced Ovarian Cancer Sensitive to Platinum-based ChemotherapyPhase 2NCT00929162
ZD4054 (Zibotentan) or Placebo Plus Chemotherapy in Patients With Advanced Ovarian Cancer
A Phase 2 study testing ZD4054 Zibotentan, Paclitaxel and Carboplatin in people with Patients With Advanced Ovarian Cancer Sensitive to Platinum-based Chemotherapy, run by AstraZeneca at 20 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Patients With Advanced Ovarian Cancer Sensitive to Platinum-based Chemotherapy
- What is being tested?
- ZD4054 Zibotentan, Paclitaxel and Carboplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 20 sitesin 2 countries
- Study dates
- Jun 2009to Jun 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
20 sites in 2 countries.
20 sites in 2 countries
Germany13 sites
Research Site
Berlin
Research Site
Dresden
Research Site
Düsseldorf
Research Site
Essen
Research Site
Karlsruhe
Research Site
Kassel
Research Site
Kiel
Research Site
Lich
Research Site
Magdeburg
Research Site
Marburg
Research Site
München
Research Site
Rostock
Research Site
Wiesbaden
Italy7 sites
Research Site
Aviano, PN
Research Site
Campobasso
Research Site
Milan, MI
Research Site
Modena
Research Site
Naples
Research Site
Perugia, PG
Research Site
Roma, Roma
About this study
Official title: 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
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.
- Being tested
- ZD4054 Zibotentan, Paclitaxel, Carboplatin, Placebo
- Keywords
- ovarian, cancer, chemotherapy, sensitive, ZD4054
- Medical subject headings
- Neoplasms, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZD4054 ZibotentanDrug
10 mg oral tablets once daily
PaclitaxelDrug
175mg/m2 IV on day 1 every 3 weeks
CarboplatinDrug
Carboplatin AUC of 5.0 IV on day 1 every 3 weeks
PlaceboDrug
matching placebo for ZD4054 10 mg
| Study group | Role | What they receive |
|---|---|---|
| ZD4054 + paclitaxel + carboplatin | Experimental | ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks Receives: Drug: ZD4054 Zibotentan; Drug: Paclitaxel; Drug: Carboplatin |
| Placebo + paclitaxel + carboplatin | Placebo comparator | Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks Receives: Drug: Paclitaxel; Drug: Carboplatin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Median time (in months) from randomisation until clinical progression of disease using the Kaplan-Meier method.
Measured: Patients were followed for progression up to 2 years
Secondary outcomes (2)
Overall Survival
Median time (in months) from randomisation until death using the Kaplan-Meier method.
Measured: 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
Measured: While receiving paclitaxel + carboplatin study visits were aliged with its administration ie every 3 weeks, then every 6 weeks (up to 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionJun 2011
- Study completionJun 2011
Why it stopped: Primary objective of the trial was not met and so there was no benefit in collecting further information
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients With Advanced Ovarian Cancer Sensitive to Platinum-based ChemotherapyStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ISTITUTO REGINA ELENA - CENTRO RICERCHE SPERIMENTALI
- Responsible party
- Sponsor
- Investigators
- Tom Morris, Study director, AstraZeneca, Alderley ParkIan Thomas, Study chair, AstraZeneca, Alderley Park
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00929162
- Sponsor's protocol ID
- D4320C00036
- Status last verified
- Aug 2012
- First submitted
- 25 Jun 2009
- Last updated
- 7 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 23234805
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00929162
- Acronym / sponsor ID
- D4320C00036
- Keywords
- ovarian, cancer, chemotherapy, sensitive, ZD4054
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Primary objective of the trial was not met and so there was no benefit in collecting further information
- Enrolment
- 120 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- ISTITUTO REGINA ELENA - CENTRO RICERCHE SPERIMENTALI
- Study start
- Jun 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 26 Jun 2009 (estimated)
- Results
- Posted 6 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ZD4054 + paclitaxel + carboplatin | Experimental | Drug: ZD4054 Zibotentan, Drug: Paclitaxel, Drug: CarboplatinZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks |
| Placebo + paclitaxel + carboplatin | Placebo comparator | Drug: Paclitaxel, Drug: Carboplatin, Drug: PlaceboPlacebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZD4054 Zibotentan10 mg oral tablets once daily | Drug | ZD4054 + paclitaxel + carboplatin |
| Paclitaxel175mg/m2 IV on day 1 every 3 weeks | Drug | Placebo + paclitaxel + carboplatin, ZD4054 + paclitaxel + carboplatin |
| CarboplatinCarboplatin AUC of 5.0 IV on day 1 every 3 weeks | Drug | Placebo + paclitaxel + carboplatin, ZD4054 + paclitaxel + carboplatin |
| Placebomatching placebo for ZD4054 10 mg | Drug | Placebo + paclitaxel + carboplatin |
Primary outcome
Progression Free Survival
Time frame: Patients were followed for progression up to 2 years
Median time (in months) from randomisation until clinical progression of disease using the Kaplan-Meier method.
2 secondary outcomes
Overall Survival
Time frame: Patients were followed for survival up to 2 years
Tumour Response Rate
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23234805Cognetti 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tom Morris study director
AstraZeneca, Alderley Park
Ian Thomas study chair
AstraZeneca, Alderley Park
20 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ZD4054 Zibotentan, Paclitaxel and Carboplatin in people with Patients With Advanced Ovarian Cancer Sensitive to Platinum-based Chemotherapy, run by AstraZeneca at 20 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Germany, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: Patients were followed for progression up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00929162, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2012.