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This study will investigate the efficacy and safety of bevacizumab + fotemustine in patients with stage IV melanoma, previously untreated with chemo- or immunotherapy for metastatic disease. Patients will receive Avastin (15mg/kg intravenously[IV]) on Day 1 of every 3 week cycle, in combination with fotemustine (100mg/m² IV) on Days 1, 8 and 15, followed by 4 weeks rest, followed by 100mg/m² IV every 3 weeks for 4-6 cycles. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bevacizumab [Avastin] | Drug | 15 mg/kg intravenously on day 1 of every 3 week cycle |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Complete Response (CR) or Partial Response (PR) | The percentage of participants with an objective response, defined as achieving CR or PR, as evaluated by the Response Evaluation Criteria In Solid Tumors (RECIST) criteria. CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target), PR: at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. | Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months |
| Percentage of Participants With Clinical Benefit of CR, PR, or Stable Disease (SD) | The percentage of participants with an objective response of CR, PR, or SD, as evaluated by RECIST criteria. CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target), PR: at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD. SD: steady state of disease. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for pregressive disease (PD). The clinical benefit was finally assessed by computing absolute frequencies and percentages participants with best overall tumor response equal to CR, PR, or SD. | Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Progression (TTP) - Percentage of Participants With an Event | TTP was defined as the time in days from the date of first study treatment until the date of tumor progression or death. Failure events were defined as occurrence of death or progression of disease. Data for participants who were alive without tumor progression at the end of the study were censured at the end of the observation period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florence | 50100 | Italy | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21030496 | Derived | Del Vecchio M, Mortarini R, Canova S, Di Guardo L, Pimpinelli N, Sertoli MR, Bedognetti D, Queirolo P, Morosini P, Perrone T, Bajetta E, Anichini A. Bevacizumab plus fotemustine as first-line treatment in metastatic melanoma patients: clinical activity and modulation of angiogenesis and lymphangiogenesis factors. Clin Cancer Res. 2010 Dec 1;16(23):5862-72. doi: 10.1158/1078-0432.CCR-10-2363. Epub 2010 Oct 28. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bevacizumab + Fotemustine | Cycle 1 (3-week cycle): Participants received bevacizumab 15 milligrams/kilogram (mg/kg) intravenously (IV) on Day 1 and fotemustine 100 mg per square meter (mg/m^2) IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated. Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated. Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles. Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Population: all participants who signed the informed consent form, were assigned a study patient number, and took at least one dose of each drug of study combination.
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| ID | Title | Description |
|---|---|---|
| BG000 | Bevacizumab + Fotemustine | Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated. Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated. Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles. Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Complete Response (CR) or Partial Response (PR) | The percentage of participants with an objective response, defined as achieving CR or PR, as evaluated by the Response Evaluation Criteria In Solid Tumors (RECIST) criteria. CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target), PR: at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. | Intent-to-Treat (ITT) Population: all participants who signed the informed consent form and were assigned a study patient number; data for 1 participant were not assessable as the participant was discontinued from the study due to a protocol violation. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months |
|
From date of first administration of study drug to 28 days after last administration of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bevacizumab + Fotemustine | Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated. Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated. Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles. Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (11.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (11.1) | Non-systematic Assessment |
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-LaRoche | 800-821-8590 | genentech@druginfo.com |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| C054368 | fotemustine |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| fotemustine |
| Drug |
100 mg/m² intravenously on Days 1, 8, and 15, followed by 4 weeks of rest, then every 21 days up to 4 to 6 cycles |
|
| Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months |
| TTP - Time to Event | TTP was defined as the time in days from the of first study treatment until the date of tumor progression or death. Failure events were defined as occurrence of death or progression of disease. Data for participants who were alive without tumor progression at the end of the study were censored at the end of the observation period. Median TTP was estimated using the Kaplan-Meier method. | Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months |
| Duration of CR - Percentage of Participants With an Event | Evaluated only for participants whose best overall response was CR. The start date was the date of first documented CR and the end date was defined as the date of first documented progression of disease, or death. Participants who did not experience progression of disease were censored at last tumor assessment date or at maximum follow-up. | Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months |
| Duration of CR - Time to Event | The start date was the date of first documented CR and the end date was defined as the date of first documented progression of disease, or death. Participants who did not experience progression of disease were censored at last tumor assessment date or at maximum follow-up. Median duration of CR was estimated using the Kaplan-Meier method. | Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months |
| Duration of Overall Response of CR or PR - Percentage of Participants With an Event | The start date was the date of first documented CR or PR and the end date was defined as the date of first documented progression of disease, or death. Participants who did not experience progression of disease were censored at last tumor assessment date or at maximum follow-up. | Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months |
| Duration of Overall Response of CR or PR - Time to Event | The start date was the date of first documented CR or PR and the end date was defined as the date of first documented progression of disease. Participants who did not experience progression of disease were censored at last tumor assessment date or at maximum follow-up. Median duration of CR or PR was estimated using the Kaplan-Meier method. | Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months |
| Duration of Stable Disease - Percentage of Participants With an Event | Stable disease was defined as achieving CR, PR, or SD. The start date was the date of first documented CR, PR, or SD and the end date was defined as the date of first documented progression of disease, or death. Participants who did not experience progression of disease were censored at last tumor assessment date or at maximum follow-up. | Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months |
| Duration of Stable Disease - Time to Event | Stable disease was defined as achieving CR, PR, or SD. The start date was the date of first documented CR, PR, or SD and the end date was defined as the date of first documented progression of disease, or death. Participants who did not experience progression of disease were censored at last tumor assessment date or at maximum follow-up. Median duration of CR, PR, or SD was estimated using the Kaplan-Meier method. | Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months |
| Overall Survival (OS) - Percentage of Participants With an Event | OS was defined as the time from the starting day of the therapy up to death or the last date the participant was known to be alive. | Baseline, every 3 weeks to end-of-treatment, every 3 months during follow-up, to death or end-of-study (maximum of 36 months) |
| OS - Time to Event | The time from the starting day of the therapy up to death or the last date the participant was known to be alive. Median OS was estimated using the Kaplan-Meier method. | Baseline, every 3 weeks to end-of-treatment, every 3 months during follow-up, to death or end-of-study (maximum of 36 months) |
| Time to Treatment Failure (TTF) - Percentage of Participants With an Event | The time from date of start of treatment to the earliest among date of progression, date of death due to any cause, or date of discontinuation due to reason other than 'Protocol Violation' or 'Administrative Problem'. For the participants who did not experience treatment failure, TTF was censored at last adequate tumour assessment. | Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months |
| TTF - Time to Event | The time from date of start of treatment to the earliest among date of progression, date of death due to any cause, or date of discontinuation due to reason other than 'Protocol Violation' or 'Administrative Problem'. For the participants who did not experience treatment failure, TTF was censored at last adequate tumour assessment. Median TTF was estimated using the Kaplan-Meier method. | Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months |
| Time to CR - Percentage of Participants With an Event | The time between date of start of treatment until first documented CR. This analysis included all responders. Participants who did not achieve a confirmed CR were censored at last adequate tumour assessment date or at maximum follow-up. | Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months |
| Time to CR - Time To Event | The time between date of start of treatment until first documented CR. This analysis included all responders. Participants who did not achieve a confirmed CR were censored at last adequate tumour assessment date or at maximum follow-up. Mean time to CR was estimated using the Kaplan-Meier method. | Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months |
| Time to Overall Response of CR or PR - Percentage of Participants With an Event | The time between date of start of treatment until first documented response of CR or PR. This analysis included all responders. Participants who did not achieve a confirmed CR or PR were censored at last adequate tumour assessment date or at maximum follow-up. | Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months |
| Time to Overall Response of CR or PR - Time to Event | The time between date of start of treatment until first documented response of CR or PR. This analysis included all responders. Participants who did not achieve a confirmed CR or PR were censored at last adequate tumor assessment date or at maximum follow-up. Mean time to CR or PR was estimated using the Kaplan-Meier method. | Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months |
| Genova |
| 16132 |
| Italy |
| Milan | 20133 | Italy |
| Torino | 10126 | Italy |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated. Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated. Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles. Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity. |
|
|
| Secondary | Time to Progression (TTP) - Percentage of Participants With an Event | TTP was defined as the time in days from the date of first study treatment until the date of tumor progression or death. Failure events were defined as occurrence of death or progression of disease. Data for participants who were alive without tumor progression at the end of the study were censured at the end of the observation period. | ITT population; data for 1 participant were not assessable as the participant was discontinued from the study due to a protocol violation. | Posted | Number | percentage of participants | Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months |
|
|
|
| Secondary | TTP - Time to Event | TTP was defined as the time in days from the of first study treatment until the date of tumor progression or death. Failure events were defined as occurrence of death or progression of disease. Data for participants who were alive without tumor progression at the end of the study were censored at the end of the observation period. Median TTP was estimated using the Kaplan-Meier method. | ITT population; data for 1 participant were not assessable as the participant was discontinued from the study due to a protocol violation. | Posted | Median | 95% Confidence Interval | days | Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months |
|
|
|
| Secondary | Duration of CR - Percentage of Participants With an Event | Evaluated only for participants whose best overall response was CR. The start date was the date of first documented CR and the end date was defined as the date of first documented progression of disease, or death. Participants who did not experience progression of disease were censored at last tumor assessment date or at maximum follow-up. | ITT population; only participants with a best overall response of CR were included in the analysis. | Posted | Number | percentage of participants | Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months |
|
|
|
| Secondary | Duration of CR - Time to Event | The start date was the date of first documented CR and the end date was defined as the date of first documented progression of disease, or death. Participants who did not experience progression of disease were censored at last tumor assessment date or at maximum follow-up. Median duration of CR was estimated using the Kaplan-Meier method. | ITT population; only participants with a CR were included in the analysis | Posted | Median | 95% Confidence Interval | days | Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months |
|
|
|
| Secondary | Duration of Overall Response of CR or PR - Percentage of Participants With an Event | The start date was the date of first documented CR or PR and the end date was defined as the date of first documented progression of disease, or death. Participants who did not experience progression of disease were censored at last tumor assessment date or at maximum follow-up. | ITT population; only participants with a best overall response of CR or PR were included in the analysis. | Posted | Number | percentage of participants | Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months |
|
|
|
| Primary | Percentage of Participants With Clinical Benefit of CR, PR, or Stable Disease (SD) | The percentage of participants with an objective response of CR, PR, or SD, as evaluated by RECIST criteria. CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target), PR: at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD. SD: steady state of disease. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for pregressive disease (PD). The clinical benefit was finally assessed by computing absolute frequencies and percentages participants with best overall tumor response equal to CR, PR, or SD. | ITT population; data for 1 participant were not assessable as the participant was discontinued from the study due to a protocol violation. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months |
|
|
|
| Secondary | Duration of Overall Response of CR or PR - Time to Event | The start date was the date of first documented CR or PR and the end date was defined as the date of first documented progression of disease. Participants who did not experience progression of disease were censored at last tumor assessment date or at maximum follow-up. Median duration of CR or PR was estimated using the Kaplan-Meier method. | ITT population; only participants with a best overall response of CR or PR were included in the analysis. | Posted | Median | 95% Confidence Interval | days | Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months |
|
|
|
| Secondary | Duration of Stable Disease - Percentage of Participants With an Event | Stable disease was defined as achieving CR, PR, or SD. The start date was the date of first documented CR, PR, or SD and the end date was defined as the date of first documented progression of disease, or death. Participants who did not experience progression of disease were censored at last tumor assessment date or at maximum follow-up. | ITT population; only participants with a best overall response of CR, PR, or SD were included in the anlaysis. | Posted | Number | percentage of participants | Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months |
|
|
|
| Secondary | Duration of Stable Disease - Time to Event | Stable disease was defined as achieving CR, PR, or SD. The start date was the date of first documented CR, PR, or SD and the end date was defined as the date of first documented progression of disease, or death. Participants who did not experience progression of disease were censored at last tumor assessment date or at maximum follow-up. Median duration of CR, PR, or SD was estimated using the Kaplan-Meier method. | ITT population; only participants with a best overall response of CR, PR, or SD were included in the analysis. | Posted | Median | 95% Confidence Interval | days | Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months |
|
|
|
| Secondary | Overall Survival (OS) - Percentage of Participants With an Event | OS was defined as the time from the starting day of the therapy up to death or the last date the participant was known to be alive. | ITT population | Posted | Number | percentage of participants | Baseline, every 3 weeks to end-of-treatment, every 3 months during follow-up, to death or end-of-study (maximum of 36 months) |
|
|
|
| Secondary | OS - Time to Event | The time from the starting day of the therapy up to death or the last date the participant was known to be alive. Median OS was estimated using the Kaplan-Meier method. | ITT population | Posted | Median | 95% Confidence Interval | days | Baseline, every 3 weeks to end-of-treatment, every 3 months during follow-up, to death or end-of-study (maximum of 36 months) |
|
|
|
| Secondary | Time to Treatment Failure (TTF) - Percentage of Participants With an Event | The time from date of start of treatment to the earliest among date of progression, date of death due to any cause, or date of discontinuation due to reason other than 'Protocol Violation' or 'Administrative Problem'. For the participants who did not experience treatment failure, TTF was censored at last adequate tumour assessment. | ITT Population; data for 1 participant were not assessable as the participant was discontinued from the study due to a protocol violation. | Posted | Number | percentage of participants | Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months |
|
|
|
| Secondary | TTF - Time to Event | The time from date of start of treatment to the earliest among date of progression, date of death due to any cause, or date of discontinuation due to reason other than 'Protocol Violation' or 'Administrative Problem'. For the participants who did not experience treatment failure, TTF was censored at last adequate tumour assessment. Median TTF was estimated using the Kaplan-Meier method. | ITT population; data for 1 participant were not assessable as the participant was discontinued from the study due to a protocol violation. | Posted | Median | 95% Confidence Interval | days | Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months |
|
|
|
| Secondary | Time to CR - Percentage of Participants With an Event | The time between date of start of treatment until first documented CR. This analysis included all responders. Participants who did not achieve a confirmed CR were censored at last adequate tumour assessment date or at maximum follow-up. | ITT Population; data for 1 participant were not assessable as the participant was discontinued from the study due to a protocol violation. | Posted | Number | percentage of participants | Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months |
|
|
|
| Secondary | Time to CR - Time To Event | The time between date of start of treatment until first documented CR. This analysis included all responders. Participants who did not achieve a confirmed CR were censored at last adequate tumour assessment date or at maximum follow-up. Mean time to CR was estimated using the Kaplan-Meier method. | ITT population; only participants with a CR were included in the analysis. | Posted | Mean | Standard Deviation | days | Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months |
|
|
|
| Secondary | Time to Overall Response of CR or PR - Percentage of Participants With an Event | The time between date of start of treatment until first documented response of CR or PR. This analysis included all responders. Participants who did not achieve a confirmed CR or PR were censored at last adequate tumour assessment date or at maximum follow-up. | ITT Population; data for 1 participant were not assessable as the participant was discontinued from the study due to a protocol violation. | Posted | Number | percentage of participants | Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months |
|
|
|
| Secondary | Time to Overall Response of CR or PR - Time to Event | The time between date of start of treatment until first documented response of CR or PR. This analysis included all responders. Participants who did not achieve a confirmed CR or PR were censored at last adequate tumor assessment date or at maximum follow-up. Mean time to CR or PR was estimated using the Kaplan-Meier method. | ITT Population; only participants with a response of CR or PR were included in the analysis. | Posted | Mean | Standard Deviation | days | Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months |
|
|
|
| 4 |
| 20 |
| 18 |
| 20 |
| Metrorrhagia | Reproductive system and breast disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Cataract | Eye disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Gastric dilatation | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Oesophageal achalasia | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Salivary gland mass | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Oedema | General disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
|
| Lymphangitis | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA (11.1) | Non-systematic Assessment |
|
| Alanine aminotransferase | Investigations | MedDRA (11.1) | Non-systematic Assessment |
|
| Aspartate aminotransferase | Investigations | MedDRA (11.1) | Non-systematic Assessment |
|
| Haematocrit decreased | Investigations | MedDRA (11.1) | Non-systematic Assessment |
|
| Red blood cell count decreased | Investigations | MedDRA (11.1) | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Vertebral column mass | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Metrorrhagia | Reproductive system and breast disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
The Study being conducted under this agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request the Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |