Ovarian NeoplasmsPhase 2NCT00791778
Comparison of Nexavar/Placebo as Maintenance Therapy for Patients With Advanced Ovarian or Primary Peritoneal Cancer
A Phase 2 study testing Sorafenib (Nexavar, BAY43-9006) in people with Ovarian Neoplasms, run by Bayer at 59 sites in 14 countries.
Trial summary
Comparison of Nexavar with a placebo as maintenance therapy for patients with advanced Ovarian or primary Peritoneal cancers in complete remission following surgery and one regimen of chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ovarian Neoplasms
- What is being tested?
- Sorafenib (Nexavar, BAY43-9006)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 246 participants
- Where
- 59 sitesin 14 countries
- Study dates
- Nov 2008to Dec 2012
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed International Federation of Gynecology and Obstetrics (FIGO) stage (67) III or IV ovarian epithelial cancer or primary peritoneal cancer at presentation. Patients must have achieved a clinical complete response (disappearance of all clinical and radiological evidence of tumor) after only one regimen (4-6 cycles) of platinum and taxane-based standard chemotherapy received after tumor debulkment.
- Normal serum CA125 (cancer-associated tumor marker) level within 7 days of first dose of sorafenib.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- All scans used to document complete response must be done within 30 days prior to randomization.
- Patients must be able to swallow and retain oral medication.
Who cannot join
- Patients with any residual cancer tissue after the completion of chemotherapy detectable by standard Computed tomography (CT) or magnetic resonance imaging (MRI).
- Prior local radiotherapy, neoadjuvant chemotherapy or intraperitoneal chemotherapy.
- Histologic subtypes of ovarian cancer other than epithelial (i.e. sarcoma, lymphoma, germ cell).
- Major surgery, open biopsy, or significant traumatic injury within 30 days prior to randomization.
Trial locations and contacts
59 sites in 14 countries.
59 sites in 14 countries
South Korea9 sites
Study site
Daegu, 700-712
Study site
Gyeonggi-do, 410-769
Study site
Incheon, 405-760
Study site
Seoul, Seoul Teugbyeolsi, 110-744
Study site
Seoul, 120-752
Study site
Seoul, 135-710
Study site
Seoul, 138-736
Study site
Seoul, 158-710
Study site
Sŏwŏn, 443-721
Poland7 sites
Study site
Bialystok, 15-027
Study site
Gdynia, 81-519
Study site
Krakow, 31-115
Study site
Lublin
Study site
Poznan, 61-866
Study site
Poznan, 61-878
Study site
Warsaw, 02-781
Belgium6 sites
Study site
Bruxelles - Brussel, 1000
Study site
Bruxelles - Brussel, 1200
Study site
Edegem, 2650
Study site
La Louvière, 7100
Study site
Leuven, 3000
Study site
Wilrijk, 2610
Japan6 sites
Study site
Isehara, Kanagawa, 259-1193
Study site
Kashiwa, Chiba, 277-8567
Study site
Koto-ku, Tokyo, 135-8550
Study site
Minato-ku, Tokyo, 105-8471
Study site
Nagoya, Aichi-ken, 464-8681
Study site
Shimotsuke, Tochigi, 329-0498
France5 sites
Study site
Angers, 49933
Study site
Caen, 14076
Study site
Lyon, 39373
Study site
Tours, 37044
Study site
Villejuif, 94805
Italy5 sites
Study site
Campobasso, 00168
Study site
Meldola, Forlì, 47014
Study site
Milan, 20141
Study site
Roma, 00167
Study site
Roma, 00168
Spain5 sites
Study site
Lugo, Lugo, 27003
Study site
Madrid, Madrid, 28040
Study site
Madrid, Madrid, 28041
Study site
Sabadell, Barcelona, 08208
Study site
Seville, Sevilla, 41013
United States4 sites
Study site
Augusta, Georgia, 30912
Study site
Jacksonville, Florida, 32209
Study site
La Jolla, California, 92037
Study site
Scarborough, Maine, 04074
Canada4 sites
Study site
Hamilton, Ontario, L8V 5C2
Study site
London, Ontario, N6A 4L6
Study site
Montreal, Quebec, H2L 4M1
Study site
Toronto, Ontario, M5G 2M9
Netherlands2 sites
Study site
Maastricht, 6229 HX
Study site
The Hague, 2545 CH
About this study
Official title: A Double-Blind, Randomized Phase II Study Evaluating the Efficacy and Safety of Sorafenib Compared to Placebo in Ovarian Epithelial Cancer or Primary Peritoneal Cancer Patients Who Have Achieved a Complete Clinical Response After Standard Platinum/Taxane Containing Chemotherapy
Comparison of Nexavar with a placebo as maintenance therapy for patients with advanced Ovarian or primary Peritoneal cancers in complete remission following surgery and one regimen of chemotherapy.
- Conditions
- Ovarian Neoplasms
- Being tested
- Sorafenib (Nexavar, BAY43-9006), Placebo
- Keywords
- Peritoneal Neoplasma
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sorafenib (Nexavar, BAY43-9006)Drug
Patients in Sorafenib arm will receive 2 Sorafenib tablets (200 mg each) twice a day and in continuous administration.
PlaceboDrug
Patients in Placebo arm will receive 2 matching placebo tablets twice a day and in continuous administration.
| Study group | Role | What they receive |
|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | Experimental | Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid) Receives: Drug: Sorafenib (Nexavar, BAY43-9006) |
| Placebo | Placebo comparator | Participants received 2 matching placebo tablets per oral twice daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS), Based on Radiological or Pathologic Assessment
Time from randomization to the first documented disease progression by radiological or pathologic assessment or death due to any cause whichever occurred first. For patients who had not progressed or died at the time of analysis, PFS was censored at the date of their last evaluable tumor scan.
Measured: From randomization of the first patient until 32.5 months later, assessed every 8 weeks
Secondary outcomes (2)
Time to First Pathologic CA-125 (Cancer-associated Tumor Marker) Serum Level
Time from randomization to the first documented increase of CA-125 above the upper limit of normal. Patients without pathologic CA-125 increase at the time of analysis were censored at their last date of evaluation of CA-125.
Measured: From randomization of the first patient until 32.5 months later, assessed every 8 weeks
Overall Survival (OS)
The OS time was measured from the date of randomization until the date of death due to any cause. Patients who were alive at the time of analysis were censored at the date of the last contact (last time the patient was known to be alive).
Measured: From randomization of the first patient until 32.5 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionJul 2011
- Study completionDec 2012
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 (2)Papers the sponsor has linked to this study.
- Other trials for Ovarian NeoplasmsStudies of the same condition, open and under way.
- More trials run by BayerThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00791778
- Sponsor's protocol ID
- 12007
- Other IDs
- 2008-004429-41, 2008
- Status last verified
- Jun 2015
- First submitted
- 14 Nov 2008
- Last updated
- 28 Sep 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Herzog TJ, Scambia G, Kim BG, Lhomme C, Markowska J, Ray-Coquard I, Sehouli J, Colombo N, Shan M, Petrenciuc O, Oza A. A randomized phase II trial of maintenance therapy with Sorafenib in front-line ovarian carcinoma. Gynecol Oncol. 2013 Jul;130(1):25-30. doi: 10.1016/j.ygyno.2013.04.011. Epub 2013 Apr 13.
PubMed 23591401Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.
PubMed 37185961
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized Phase II Study Evaluating the Efficacy and Safety of Sorafenib Compared to Placebo in Ovarian Epithelial Cancer or Primary Peritoneal Cancer Patients Who Have Achieved a Complete Clinical Response After Standard Platinum/Taxane Containing Chemotherapy
- ClinicalTrials.gov ID
- NCT00791778
- Acronym / sponsor ID
- 12007
- Conditions
- Ovarian Neoplasms
- Keywords
- Peritoneal Neoplasma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Jul 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 17 Nov 2008 (estimated)
- Results
- Posted 30 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison of Nexavar with a placebo as maintenance therapy for patients with advanced Ovarian or primary Peritoneal cancers in complete remission following surgery and one regimen of chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | Experimental | Drug: Sorafenib (Nexavar, BAY43-9006)Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid) |
| Placebo | Placebo comparator | Drug: PlaceboParticipants received 2 matching placebo tablets per oral twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically confirmed International Federation of Gynecology and Obstetrics (FIGO) stage (67) III or IV ovarian epithelial cancer or primary peritoneal cancer at presentation. Patients must have achieved a clinical complete response (disappearance of all clinical and radiological evidence of tumor) after only one regimen (4-6 cycles) of platinum and taxane-based standard chemotherapy received after tumor debulkment.
- Normal serum CA125 (cancer-associated tumor marker) level within 7 days of first dose of sorafenib.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- All scans used to document complete response must be done within 30 days prior to randomization.
- Patients must be able to swallow and retain oral medication.
Key exclusion criteria (4 listed)
- Patients with any residual cancer tissue after the completion of chemotherapy detectable by standard Computed tomography (CT) or magnetic resonance imaging (MRI).
- Prior local radiotherapy, neoadjuvant chemotherapy or intraperitoneal chemotherapy.
- Histologic subtypes of ovarian cancer other than epithelial (i.e. sarcoma, lymphoma, germ cell).
- Major surgery, open biopsy, or significant traumatic injury within 30 days prior to randomization.
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 |
|---|---|---|
| Sorafenib (Nexavar, BAY43-9006)Patients in Sorafenib arm will receive 2 Sorafenib tablets (200 mg each) twice a day and in continuous administration. | Drug | Sorafenib (Nexavar, BAY43-9006) |
| PlaceboPatients in Placebo arm will receive 2 matching placebo tablets twice a day and in continuous administration. | Drug | Placebo |
Primary outcome
Progression-free Survival (PFS), Based on Radiological or Pathologic Assessment
Time frame: From randomization of the first patient until 32.5 months later, assessed every 8 weeks
Time from randomization to the first documented disease progression by radiological or pathologic assessment or death due to any cause whichever occurred first. For patients who had not progressed or died at the time of analysis, PFS was censored at the date of their last evaluable tumor scan.
2 secondary outcomes
Time to First Pathologic CA-125 (Cancer-associated Tumor Marker) Serum Level
Time frame: From randomization of the first patient until 32.5 months later, assessed every 8 weeks
Overall Survival (OS)
Time frame: From randomization of the first patient until 32.5 months later
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23591401Herzog TJ, Scambia G, Kim BG, Lhomme C, Markowska J, Ray-Coquard I, Sehouli J, Colombo N, Shan M, Petrenciuc O, Oza A. A randomized phase II trial of maintenance therapy with Sorafenib in front-line ovarian carcinoma. Gynecol Oncol. 2013 Jul;130(1):25-30. doi: 10.1016/j.ygyno.2013.04.011. Epub 2013 Apr 13.
- Derived from this study: PubMed 37185961Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.
- Click here to find information about studies related to Bayer Healthcare products conducted in EuropeLink provided by the sponsor.
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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.
Bayer Study Director study director
Bayer
59 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sorafenib (Nexavar, BAY43-9006) in people with Ovarian Neoplasms, run by Bayer at 59 sites in 14 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 28 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 sites in South Korea, Poland, Belgium, Japan, France and 9 more countries. 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 30 Nov 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 (PFS), Based on Radiological or Pathologic Assessment (time frame: From randomization of the first patient until 32.5 months later, assessed every 8 weeks). 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 NCT00791778, which also lists 2 linked publications.
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 28 Sep 2015.