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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-004429-41 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | Experimental | Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid) |
|
| Placebo | Placebo Comparator | Participants received 2 matching placebo tablets per oral twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | Drug | Patients in Sorafenib arm will receive 2 Sorafenib tablets (200 mg each) twice a day and in continuous administration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From randomization of the first patient until 32.5 months later, assessed every 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From randomization of the first patient until 32.5 months later, assessed every 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Assessment of Cancer Therapy (FACT)/National Comprehensive Cancer Network (NCCN) Ovarian Symptom Index (FOSI) Total Score at Cycle 1/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). | At Cycle 1 (4 weeks per Cycle)/baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| La Jolla | California | 92037 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23591401 | Result | 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. | |
| 37185961 | Derived |
| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sorafenib (Nexavar, BAY43-9006) | Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid) |
| FG001 | Placebo | Participants received 2 matching placebo tablets per oral twice daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double-blind Treatment |
|
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| Placebo | Drug | Patients in Placebo arm will receive 2 matching placebo tablets twice a day and in continuous administration. |
|
| 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). | From randomization of the first patient until 32.5 months later |
| FOSI Total Score at Cycle 3 | 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). | At Cycle 3 (4 weeks per Cycle) |
| Change From Baseline in FOSI Total Score at Cycle 3 | 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). | Baseline and Cycle 3 (4 weeks per Cycle) |
| FOSI Total Score at Cycle 5 | 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). | At Cycle 5 (4 weeks per Cycle) |
| Change From Baseline in FOSI Total Score at Cycle 5 | 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). | Baseline and Cycle 5 (4 weeks per Cycle) |
| FOSI Total Score at End of Treatment | 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). | At End of treatment (up to Cycle 33, 4 weeks per Cycle) |
| Change From Baseline in FOSI Total Score at End of Treatment | 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). | Baseline and End of treatment (up to Cycle 33, 4 weeks per Cycle) |
| EuroQol-5D (EQ-5D) Index Score at Cycle 1/Baseline | The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index score which ranges from -0.594 (worst) to 1 (best) when the United Kingdom (UK) weights are applied. | At Cycle 1 (4 weeks per Cycle)/baseline |
| EQ-5D Index Score at Cycle 3 | The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index score which ranges from -0.594 (worst) to 1 (best) when the United Kingdom (UK) weights are applied. | At Cycle 3 (4 weeks per Cycle) |
| Change From Baseline in EQ-5D Index Score at Cycle 3 | The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index. The change is calculated as score at Cycle 3 minus baseline score. The change in EQ-5D index ranges from -1.594 (most deterioration from baseline) to 1.594 (most improvement from baseline). | Baseline and Cycle 3 (4 weeks per Cycle) |
| EQ-5D Index Score at Cycle 5 | The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index score which ranges from -0.594 (worst) to 1 (best) when the United Kingdom (UK) weights are applied. | At Cycle 5 (4 weeks per Cycle) |
| Change From Baseline in EQ-5D Index Score at Cycle 5 | The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index. The change is calculated as score at Cycle 5 minus baseline score. The change in EQ-5D index ranges from -1.594 (most deterioration from baseline) to 1.594 (most improvement from baseline). | Baseline and Cycle 5 (4 weeks per Cycle) |
| EQ-5D Index Score at End of Treatment | The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index score which ranges from -0.594 (worst) to 1 (best) when the United Kingdom (UK) weights are applied. | At End of treatment (up to Cycle 33, 4 weeks per Cycle) |
| Change From Baseline in EQ-5D Index Score at End of Treatment | The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index. The change is calculated as score at End of treatment minus baseline score. The change in EQ-5D index ranges from -1.594 (most deterioration from baseline) to 1.594 (most improvement from baseline). | Baseline and End of treatment (up to Cycle 33, 4 weeks per Cycle) |
| EQ-5D Visual Analogue Scale (VAS) Score at Cycle 1/Baseline | The EQ-5D also contains a VAS, which records the respondent's self-rated health status on a vertical graduated scale. The scale ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). | At Cycle 1 (4 weeks per Cycle)/baseline |
| EQ-5D VAS Score at Cycle 3 | The EQ-5D also contains a VAS, which records the respondent's self-rated health status on a vertical graduated scale. The scale ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). | At Cycle 3 (4 weeks per Cycle) |
| Change From Baseline in EQ-5D VAS Score at Cycle 3 | The EQ-5D also contains a VAS, which records the respondent's self-rated health status on a vertical graduated scale. The change is calculated as score at Cycle 3 minus baseline score. The change in EQ-5D VAS ranges from -100 (most deterioration from baseline) to 100 (most improvement from baseline). | Baseline and Cycle 3 (4 weeks per Cycle) |
| EQ-5D VAS Score at Cycle 5 | The EQ-5D also contains a VAS, which records the respondent's self-rated health status on a vertical graduated scale. The scale ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). | At Cycle 5 (4 weeks per Cycle) |
| Change From Baseline in EQ-5D VAS Score at Cycle 5 | The EQ-5D also contains a VAS, which records the respondent's self-rated health status on a vertical graduated scale. The change is calculated as score at Cycle 5 minus baseline score. The change in EQ-5D VAS ranges from -100 (most deterioration from baseline) to 100 (most improvement from baseline). | Baseline and Cycle 5 (4 weeks per Cycle) |
| EQ-5D VAS Score at End of Treatment | The EQ-5D also contains a VAS, which records the respondent's self-rated health status on a vertical graduated scale. The scale ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). | At End of treatment (up to Cycle 33, 4 weeks per Cycle) |
| Change From Baseline in EQ-5D VAS Score at End of Treatment | The EQ-5D also contains a VAS, which records the respondent's self-rated health status on a vertical graduated scale. The change is calculated as score at End of treatment minus baseline score. The change in EQ-5D VAS ranges from -100 (most deterioration from baseline) to 100 (most improvement from baseline). | Baseline and End of treatment (up to Cycle 33, 4 weeks per Cycle) |
| Jacksonville |
| Florida |
| 32209 |
| United States |
| Augusta | Georgia | 30912 | United States |
| Scarborough | Maine | 04074 | United States |
| Bruxelles - Brussel | 1000 | Belgium |
| Bruxelles - Brussel | 1200 | Belgium |
| Edegem | 2650 | Belgium |
| La Louvière | 7100 | Belgium |
| Leuven | 3000 | Belgium |
| Wilrijk | 2610 | Belgium |
| Hamilton | Ontario | L8V 5C2 | Canada |
| London | Ontario | N6A 4L6 | Canada |
| Toronto | Ontario | M5G 2M9 | Canada |
| Montreal | Quebec | H2L 4M1 | Canada |
| Jyväskylä | FI-40620 | Finland |
| Kuopio | FIN- 70211 | Finland |
| Angers | 49933 | France |
| Caen | 14076 | France |
| Lyon | 39373 | France |
| Tours | 37044 | France |
| Villejuif | 94805 | France |
| Berlin | State of Berlin | 13353 | Germany |
| Hong Kong | Hong Kong |
| Meldola | Forlì | 47014 | Italy |
| Campobasso | 00168 | Italy |
| Milan | 20141 | Italy |
| Roma | 00167 | Italy |
| Roma | 00168 | Italy |
| Nagoya | Aichi-ken | 464-8681 | Japan |
| Kashiwa | Chiba | 277-8567 | Japan |
| Isehara | Kanagawa | 259-1193 | Japan |
| Shimotsuke | Tochigi | 329-0498 | Japan |
| Koto-ku | Tokyo | 135-8550 | Japan |
| Minato-ku | Tokyo | 105-8471 | Japan |
| Maastricht | 6229 HX | Netherlands |
| The Hague | 2545 CH | Netherlands |
| Bialystok | 15-027 | Poland |
| Gdynia | 81-519 | Poland |
| Krakow | 31-115 | Poland |
| Lublin | Poland |
| Poznan | 61-866 | Poland |
| Poznan | 61-878 | Poland |
| Warsaw | 02-781 | Poland |
| Singapore | 119228 | Singapore |
| Singapore | 229899 | Singapore |
| Seoul | Seoul Teugbyeolsi | 110-744 | South Korea |
| Daegu | 700-712 | South Korea |
| Gyeonggi-do | 410-769 | South Korea |
| Incheon | 405-760 | South Korea |
| Seoul | 120-752 | South Korea |
| Seoul | 135-710 | South Korea |
| Seoul | 138-736 | South Korea |
| Seoul | 158-710 | South Korea |
| Sŏwŏn | 443-721 | South Korea |
| Sabadell | Barcelona | 08208 | Spain |
| Lugo | Lugo | 27003 | Spain |
| Madrid | Madrid | 28040 | Spain |
| Madrid | Madrid | 28041 | Spain |
| Seville | Sevilla | 41013 | Spain |
| Gaitskell 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. |
| COMPLETED |
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| NOT COMPLETED |
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| Follow-up |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sorafenib (Nexavar, BAY43-9006) | Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid) |
| BG001 | Placebo | Participants received 2 matching placebo tablets per oral twice daily |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Age, Customized | Number | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Performance status, Eastern Cooperative Oncology Group (ECOG) | Eastern Cooperative Oncology Group (ECOG) Performance Status is a scale that measures how cancer affects the daily life of a patient on an ordinal scale from grade 0 (best) to grade 5 (worst). | Number | Participants |
| |||||||||||||||
| Type of cancer | Patients were to have either ovarian epithelial cancer or primary peritoneal cancer. Primary peritoneal carcinoma involves the extra-ovarian peritoneum significantly and the ovarian surface minimally or not at all. | Number | Participants |
| |||||||||||||||
| Previous Intra-peritoneal (IP) chemotherapy | The presence or absence of any IP chemotherapy before enrollment into the study. | Number | Participants |
| |||||||||||||||
| Surgical cytoreduction | The degree of residual disease following initial diagnosis and surgical debulkment: optimal surgical cytoreduction (any/each lesion remaining after surgery ≤1 cm) or suboptimal surgical cytoreduction (any/each lesion remaining after surgery >1cm) | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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. | Full analysis set (FAS)=all randomized participants | Posted | Median | 95% Confidence Interval | Days | From randomization of the first patient until 32.5 months later, assessed every 8 weeks |
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| Secondary | 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. | 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 | Posted | Median | 95% Confidence Interval | Days | From randomization of the first patient until 32.5 months later, assessed every 8 weeks |
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| Secondary | 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). | FAS=all randomized participants | Posted | Median | 95% Confidence Interval | Days | From randomization of the first patient until 32.5 months later |
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| Other Pre-specified | Functional Assessment of Cancer Therapy (FACT)/National Comprehensive Cancer Network (NCCN) Ovarian Symptom Index (FOSI) Total Score at Cycle 1/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). | Patient-reported outcomes (PRO) analysis set=the FAS population with evaluable PRO assessments at baseline and at least one post-baseline assessment | Posted | Mean | Standard Deviation | Scores on a scale | At Cycle 1 (4 weeks per Cycle)/baseline |
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| Other Pre-specified | FOSI Total Score at Cycle 3 | 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). | PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 3 | Posted | Mean | Standard Deviation | Scores on a scale | At Cycle 3 (4 weeks per Cycle) |
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| Other Pre-specified | Change From Baseline in FOSI Total Score at Cycle 3 | 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). | PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 3 | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and Cycle 3 (4 weeks per Cycle) |
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| Other Pre-specified | FOSI Total Score at Cycle 5 | 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). | PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 5 | Posted | Mean | Standard Deviation | Scores on a scale | At Cycle 5 (4 weeks per Cycle) |
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| Other Pre-specified | Change From Baseline in FOSI Total Score at Cycle 5 | 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). | PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 5 | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and Cycle 5 (4 weeks per Cycle) |
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| Other Pre-specified | FOSI Total Score at End of Treatment | 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). | PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at end of treatment | Posted | Mean | Standard Deviation | Scores on a scale | At End of treatment (up to Cycle 33, 4 weeks per Cycle) |
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| Other Pre-specified | Change From Baseline in FOSI Total Score at End of Treatment | 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). | PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at end of treatment | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and End of treatment (up to Cycle 33, 4 weeks per Cycle) |
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| Other Pre-specified | EuroQol-5D (EQ-5D) Index Score at Cycle 1/Baseline | The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index score which ranges from -0.594 (worst) to 1 (best) when the United Kingdom (UK) weights are applied. | PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at least one post-baseline assessment | Posted | Mean | Standard Deviation | Scores on a scale | At Cycle 1 (4 weeks per Cycle)/baseline |
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| Other Pre-specified | EQ-5D Index Score at Cycle 3 | The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index score which ranges from -0.594 (worst) to 1 (best) when the United Kingdom (UK) weights are applied. | PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 3 | Posted | Mean | Standard Deviation | Scores on a scale | At Cycle 3 (4 weeks per Cycle) |
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| Other Pre-specified | Change From Baseline in EQ-5D Index Score at Cycle 3 | The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index. The change is calculated as score at Cycle 3 minus baseline score. The change in EQ-5D index ranges from -1.594 (most deterioration from baseline) to 1.594 (most improvement from baseline). | PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 3 | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and Cycle 3 (4 weeks per Cycle) |
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| Other Pre-specified | EQ-5D Index Score at Cycle 5 | The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index score which ranges from -0.594 (worst) to 1 (best) when the United Kingdom (UK) weights are applied. | PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 5 | Posted | Mean | Standard Deviation | Scores on a scale | At Cycle 5 (4 weeks per Cycle) |
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| Other Pre-specified | Change From Baseline in EQ-5D Index Score at Cycle 5 | The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index. The change is calculated as score at Cycle 5 minus baseline score. The change in EQ-5D index ranges from -1.594 (most deterioration from baseline) to 1.594 (most improvement from baseline). | PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 5 | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and Cycle 5 (4 weeks per Cycle) |
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| Other Pre-specified | EQ-5D Index Score at End of Treatment | The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index score which ranges from -0.594 (worst) to 1 (best) when the United Kingdom (UK) weights are applied. | PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at end of treatment | Posted | Mean | Standard Deviation | Scores on a scale | At End of treatment (up to Cycle 33, 4 weeks per Cycle) |
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| Other Pre-specified | Change From Baseline in EQ-5D Index Score at End of Treatment | The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index. The change is calculated as score at End of treatment minus baseline score. The change in EQ-5D index ranges from -1.594 (most deterioration from baseline) to 1.594 (most improvement from baseline). | PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at end of treatment | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and End of treatment (up to Cycle 33, 4 weeks per Cycle) |
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| Other Pre-specified | EQ-5D Visual Analogue Scale (VAS) Score at Cycle 1/Baseline | The EQ-5D also contains a VAS, which records the respondent's self-rated health status on a vertical graduated scale. The scale ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). | PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at least one post-baseline assessment | Posted | Mean | Standard Deviation | Scores on a scale | At Cycle 1 (4 weeks per Cycle)/baseline |
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| Other Pre-specified | EQ-5D VAS Score at Cycle 3 | The EQ-5D also contains a VAS, which records the respondent's self-rated health status on a vertical graduated scale. The scale ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). | PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 3 | Posted | Mean | Standard Deviation | Scores on a scale | At Cycle 3 (4 weeks per Cycle) |
|
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| Other Pre-specified | Change From Baseline in EQ-5D VAS Score at Cycle 3 | The EQ-5D also contains a VAS, which records the respondent's self-rated health status on a vertical graduated scale. The change is calculated as score at Cycle 3 minus baseline score. The change in EQ-5D VAS ranges from -100 (most deterioration from baseline) to 100 (most improvement from baseline). | PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 3 | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and Cycle 3 (4 weeks per Cycle) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | EQ-5D VAS Score at Cycle 5 | The EQ-5D also contains a VAS, which records the respondent's self-rated health status on a vertical graduated scale. The scale ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). | PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 5 | Posted | Mean | Standard Deviation | Scores on a scale | At Cycle 5 (4 weeks per Cycle) |
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| Other Pre-specified | Change From Baseline in EQ-5D VAS Score at Cycle 5 | The EQ-5D also contains a VAS, which records the respondent's self-rated health status on a vertical graduated scale. The change is calculated as score at Cycle 5 minus baseline score. The change in EQ-5D VAS ranges from -100 (most deterioration from baseline) to 100 (most improvement from baseline). | PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 5 | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and Cycle 5 (4 weeks per Cycle) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | EQ-5D VAS Score at End of Treatment | The EQ-5D also contains a VAS, which records the respondent's self-rated health status on a vertical graduated scale. The scale ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). | PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at end of treatment | Posted | Mean | Standard Deviation | Scores on a scale | At End of treatment (up to Cycle 33, 4 weeks per Cycle) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline in EQ-5D VAS Score at End of Treatment | The EQ-5D also contains a VAS, which records the respondent's self-rated health status on a vertical graduated scale. The change is calculated as score at End of treatment minus baseline score. The change in EQ-5D VAS ranges from -100 (most deterioration from baseline) to 100 (most improvement from baseline). | PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at end of treatment | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and End of treatment (up to Cycle 33, 4 weeks per Cycle) |
|
|
From the start of treatment up to 30 days after last study drug administration.
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sorafenib (Nexavar, BAY43-9006) | Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid) | 26 | 123 | 121 | 123 | ||
| EG001 | Placebo | Participants received 2 matching placebo tablets per oral twice daily | 25 | 123 | 105 | 123 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutrophils | Blood and lymphatic system disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Lymphatics - Other | Blood and lymphatic system disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| SupraVentricular arrhythmia, Atrial fibrillation | Cardiac disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Hypertension | Cardiac disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Fistula, GI, Colon/Cecum/Appendix | Gastrointestinal disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Mucositis (functional/symptomatic), Esophagus | Gastrointestinal disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Obstruction, GI, Ileum | Gastrointestinal disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Obstruction, GI, Small bowel NOS | Gastrointestinal disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Fever | General disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Pain, Back | General disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Pain, Chest/thorax NOS | General disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Pain, Abdomen NOS | General disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Pain, Head/headache | General disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Pain, Other (Specify) | General disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Pain, Kidney | General disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Syndromes - Other | General disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| No Code In CTCAE | General disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Liver dysfunction | Hepatobiliary disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Allergic reaction | Immune system disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Allergy - Other | Immune system disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Infection (Documented clinically), Urinary tract NOS | Infections and infestations | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Infection with normal ANC, Urinary tract NOS | Infections and infestations | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Intraop injury - Other | Injury, poisoning and procedural complications | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Fracture | Musculoskeletal and connective tissue disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Secondary Malignancy (possibly related to cancer treatment) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Mood Alteration, Anxiety | Nervous system disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Neurology - Other | Nervous system disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Syncope (fainting) | Nervous system disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Fistula, GU, Vagina | Renal and urinary disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Pulmonary - Other | Respiratory, thoracic and mediastinal disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Hand-foot skin reaction | Skin and subcutaneous tissue disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Wound complication, non-infectious | Skin and subcutaneous tissue disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Dermatology - Other | Skin and subcutaneous tissue disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Rash/desquamation | Skin and subcutaneous tissue disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Ulceration | Skin and subcutaneous tissue disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Thrombosis/embolism (vascular access) | Vascular disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutrophils | Blood and lymphatic system disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Platelets | Blood and lymphatic system disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Leukocytes | Blood and lymphatic system disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Edema: Limb | Blood and lymphatic system disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Hypertension | Cardiac disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Anorexia | Gastrointestinal disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Heartburn | Gastrointestinal disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Mucositis (functional/symptomatic), Oral cavity | Gastrointestinal disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| GI - Other | Gastrointestinal disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Fever | General disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Insomnia | General disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Pain, Back | General disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Pain, Extremity - limb | General disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Pain, Abdomen NOS | General disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Pain, Head/headache | General disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Pain, Joint | General disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Pain, Muscle | General disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Pain, Other (Specify) | General disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Pain, Pain NOS | General disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Pain, Stomach | General disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Pain, Throat/pharynx/larynx | General disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Flu-like syndrome | General disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Allergic reaction | Immune system disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Infection (Documented clinically), Upper airway NOS | Infections and infestations | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Infection - Other | Infections and infestations | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Infection with unknown ANC, Upper airway NOS | Infections and infestations | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| ALT | Metabolism and nutrition disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| AST | Metabolism and nutrition disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Metabolic/Lab - Other | Metabolism and nutrition disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Musculoskeletal - Other | Musculoskeletal and connective tissue disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Neuropathy: sensory | Nervous system disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Cystitis | Renal and urinary disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Pulmonary - Other | Respiratory, thoracic and mediastinal disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Voice changes | Respiratory, thoracic and mediastinal disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Hand-foot skin reaction | Skin and subcutaneous tissue disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Dermatology - Other | Skin and subcutaneous tissue disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Rash/desquamation | Skin and subcutaneous tissue disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Flushing | Skin and subcutaneous tissue disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | NCI-CTCAE (v.3.0) | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | BAYER | clinical-trials-contact@bayerhealthcare.com |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077157 | Sorafenib |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided
| ≥ 65 - < 75 years |
|
| ≥ 75 years |
|
| Male |
|
| 1=Restricted in physically strenuous activity |
|
| 2=Ambulatory, capable of all selfcare |
|
| Missing |
|
| Peritoneal cancer |
|
| No |
|
| Suboptimal |
|
| Missing |
|
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