Trial · NCT00791778
Comparison of Nexavar/Placebo as Maintenance Therapy for Patients With Advanced Ovarian or Primary Peritoneal Cancer
NCT00791778, Phase 2, Completed, Bayer; results first posted 2012-11-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Comparison of Nexavar/Placebo as Maintenance Therapy for Patients With Advanced Ovarian or Primary Peritoneal Cancer. Trials, record NCT00791778. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00791778
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of Nexavar/Placebo as Maintenance Therapy for Patients With Advanced Ovarian or Primary Peritoneal Cancer
- NCT number
- NCT00791778
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 246 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Ovarian Neoplasms
- Interventions
- Sorafenib (Nexavar, BAY43-9006), Placebo
- First posted
- 2008-11-17
- Last updated
- 2015-09-28
- Other registries' IDs
- eudract:2008-004429-41
- Results first posted
- 2012-11-30
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS), Based on Radiological or Pathologic Assessment | 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. |
| Secondary | Time to First Pathologic CA-125 (Cancer-associated Tumor Marker) Serum Level | From randomization of the first patient until 32.5 months later, assessed every 8 weeks | 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. |
| Secondary | Overall Survival (OS) | From randomization of the first patient until 32.5 months later | 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). |
| Other | Functional Assessment of Cancer Therapy (FACT)/National Comprehensive Cancer Network (NCCN) Ovarian Symptom Index (FOSI) Total Score at Cycle 1/Baseline | At Cycle 1 (4 weeks per Cycle)/baseline | The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The FOSI total score ranges from 0 (severely symptomatic) to 32 (asymptomatic). |
| Other | FOSI Total Score at Cycle 3 | At Cycle 3 (4 weeks per Cycle) | The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The FOSI total score ranges from 0 (severely symptomatic) to 32 (asymptomatic). |
| Other | Change From Baseline in FOSI Total Score at Cycle 3 | Baseline and Cycle 3 (4 weeks per Cycle) | The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The change is calculated as score at Cycle 3 minus baseline score. The change in FOSI total score ranges from -32 (most deterioration from baseline) to 32 (most improvement from baseline). |
| Other | FOSI Total Score at Cycle 5 | At Cycle 5 (4 weeks per Cycle) | The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The FOSI total score ranges from 0 (severely symptomatic) to 32 (asymptomatic). |
| Other | Change From Baseline in FOSI Total Score at Cycle 5 | Baseline and Cycle 5 (4 weeks per Cycle) | The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The change is calculated as score at Cycle 5 minus baseline score. The change in FOSI total score ranges from -32 (most deterioration from baseline) to 32 (most improvement from baseline). |
| Other | FOSI Total Score at End of Treatment | At End of treatment (up to Cycle 33, 4 weeks per Cycle) | The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The FOSI total score ranges from 0 (severely symptomatic) to 32 (asymptomatic). |
| Other | Change From Baseline in FOSI Total Score at End of Treatment | Baseline and End of treatment (up to Cycle 33, 4 weeks per Cycle) | The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The change is calculated as score at End of treatment minus baseline score. The change in FOSI total score ranges from -32 (most deterioration from baseline) to 32 (most improvement from baseline). |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS), Based on Radiological or Pathologic Assessment | From randomization of the first patient until 32.5 months later, assessed every 8 weeks | Full analysis set (FAS)=all randomized participants | Days | MEDIAN |
| SECONDARY | Time to First Pathologic CA-125 (Cancer-associated Tumor Marker) Serum Level | From randomization of the first patient until 32.5 months later, assessed every 8 weeks | Per protocol set (PPS)=all randomized participants who had normal CA-125 serum level at baseline and at least one post-baseline CA-125 assessment | Days | MEDIAN |
| SECONDARY | Overall Survival (OS) | From randomization of the first patient until 32.5 months later | FAS=all randomized participants | Days | MEDIAN |
| OTHER_PRE_SPECIFIED | Functional Assessment of Cancer Therapy (FACT)/National Comprehensive Cancer Network (NCCN) Ovarian Symptom Index (FOSI) Total Score at Cycle 1/Baseline | At Cycle 1 (4 weeks per Cycle)/baseline | Patient-reported outcomes (PRO) analysis set=the FAS population with evaluable PRO assessments at baseline and at least one post-baseline assessment | Scores on a scale | MEAN |
| OTHER_PRE_SPECIFIED | FOSI Total Score at Cycle 3 | At Cycle 3 (4 weeks per Cycle) | PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 3 | Scores on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in FOSI Total Score at Cycle 3 | Baseline and Cycle 3 (4 weeks per Cycle) | PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 3 | Scores on a scale | MEAN |
| OTHER_PRE_SPECIFIED | FOSI Total Score at Cycle 5 | At Cycle 5 (4 weeks per Cycle) | PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 5 | Scores on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in FOSI Total Score at Cycle 5 | Baseline and Cycle 5 (4 weeks per Cycle) | PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 5 | Scores on a scale | MEAN |
| OTHER_PRE_SPECIFIED | FOSI Total Score at End of Treatment | At End of treatment (up to Cycle 33, 4 weeks per Cycle) | PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at end of treatment | Scores on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in FOSI Total Score at End of Treatment | Baseline and End of treatment (up to Cycle 33, 4 weeks per Cycle) | PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at end of treatment | Scores on a scale | MEAN |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS), Based on Radiological or Pathologic Assessment | Sorafenib (Nexavar, BAY43-9006) | 386 | 95% Confidence Interval 230 to 691 | Days | |
| Progression-free Survival (PFS), Based on Radiological or Pathologic Assessment | Placebo | 478 | 95% Confidence Interval 337 to 567 | Days | |
| Time to First Pathologic CA-125 (Cancer-associated Tumor Marker) Serum Level | Sorafenib (Nexavar, BAY43-9006) | 337 | 95% Confidence Interval 197 to NA | Days | |
| Time to First Pathologic CA-125 (Cancer-associated Tumor Marker) Serum Level | Placebo | 617 | 95% Confidence Interval 392 to NA | Days | |
| Overall Survival (OS) | Sorafenib (Nexavar, BAY43-9006) | NA | 95% Confidence Interval NA to NA | Days | |
| Overall Survival (OS) | Placebo | NA | 95% Confidence Interval NA to NA | Days | |
| Functional Assessment of Cancer Therapy (FACT)/National Comprehensive Cancer Network (NCCN) Ovarian Symptom Index (FOSI) Total Score at Cycle 1/Baseline | Sorafenib (Nexavar, BAY43-9006) | 25.909 | Standard Deviation 3.174 | Scores on a scale | |
| Functional Assessment of Cancer Therapy (FACT)/National Comprehensive Cancer Network (NCCN) Ovarian Symptom Index (FOSI) Total Score at Cycle 1/Baseline | Placebo | 25.658 | Standard Deviation 3.968 | Scores on a scale | |
| FOSI Total Score at Cycle 3 | Sorafenib (Nexavar, BAY43-9006) | 25.871 | Standard Deviation 3.166 | Scores on a scale | |
| FOSI Total Score at Cycle 3 | Placebo | 26.105 | Standard Deviation 3.414 | Scores on a scale |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-blind Treatment | STARTED | Sorafenib (Nexavar, BAY43-9006) | 123 | |
| Double-blind Treatment | STARTED | Placebo | 123 | |
| Double-blind Treatment | COMPLETED | Sorafenib (Nexavar, BAY43-9006) | 46 | |
| Double-blind Treatment | COMPLETED | Placebo | 75 | |
| Double-blind Treatment | NOT COMPLETED | Sorafenib (Nexavar, BAY43-9006) | 77 | |
| Double-blind Treatment | NOT COMPLETED | Placebo | 48 | |
| Follow-up | STARTED | Sorafenib (Nexavar, BAY43-9006) | 100 | |
| Follow-up | STARTED | Placebo | 91 | |
| Follow-up | COMPLETED | Sorafenib (Nexavar, BAY43-9006) | 95 | |
| Follow-up | COMPLETED | Placebo | 90 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events196
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Neutrophils | Blood and lymphatic system disorders | Sorafenib (Nexavar, BAY43-9006) | 12 | 123 | |
| other | Neutrophils | Blood and lymphatic system disorders | Placebo | 8 | 123 | |
| other | Platelets | Blood and lymphatic system disorders | Sorafenib (Nexavar, BAY43-9006) | 9 | 123 | |
| other | Platelets | Blood and lymphatic system disorders | Placebo | 0 | 123 | |
| other | Leukocytes | Blood and lymphatic system disorders | Sorafenib (Nexavar, BAY43-9006) | 10 | 123 | |
| other | Leukocytes | Blood and lymphatic system disorders | Placebo | 3 | 123 | |
| other | Edema: Limb | Blood and lymphatic system disorders | Sorafenib (Nexavar, BAY43-9006) | 4 | 123 | |
| other | Edema: Limb | Blood and lymphatic system disorders | Placebo | 14 | 123 | |
| other | Hypertension | Cardiac disorders | Sorafenib (Nexavar, BAY43-9006) | 45 | 123 | |
| other | Hypertension | Cardiac disorders | Placebo | 8 | 123 |
1 to 10 of 196Source ClinicalTrials.gov
See all 196 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sorafenib (Nexavar, BAY43-9006) | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Sorafenib (Nexavar, BAY43-9006) | 121 | 123 |
| Total, other adverse events | Placebo | 105 | 123 |
| Total, serious adverse events | Sorafenib (Nexavar, BAY43-9006) | 26 | 123 |
| Total, serious adverse events | Placebo | 25 | 123 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Sorafenib (Nexavar, BAY43-9006) vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00791778
GET https://conductscience.org/api/trials/v1/NCT00791778/registered?page=2