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Trial was terminated prematurely because of recruitment difficulties.
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This study will evaluate the efficacy and safety of intravenous Herceptin in patients with metastatic urothelial cancer with disease progression during platinum-based chemotherapy. The anticipated time on study treatment is until disease progression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trastuzumab Monotherapy | Experimental | Participants received an initial dose of trastuzumab 4 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1, followed by weekly doses of 2 mg/kg IV beginning on Day 8 and continuing for up to 37 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| trastuzumab | Drug | Initial dose of 4 mg/kg i.v on Day 1, followed by weekly doses of 2 mg/kg i.v. beginning on Day 8 and continuing for up to 37 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) - Percentage of Participants With an Event | PFS was defined as the time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause. | Screening, every 3 months during treatment (up to 37 weeks), and at end of treatment |
| Progression-Free Survival - Time to Event | The median time, in months, from the first study drug treatment to a PFS event. | Screening, every 3 months during treatment (up to 37 weeks), and at end of treatment |
| Percentage of Participants Progression Free at 12 and 24 Months | Months 12 and 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) - Percentage of Participants With an Event | OS was defined as the time from the start of study treatment to date of death due to any cause. | Screening, every 4 weeks during treatment (up to 37 weeks), at end of treatment, and every 3 months thereafter |
| Overall Survival - Time to Event |
Not provided
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 |
|---|---|---|---|---|---|---|
| Aschersleben | 06449 | Germany | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Trastuzumab Monotherapy | Participants received an initial dose of trastuzumab 4 milligrams per kilogram (mg/kg), intravenously (IV), on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Full analysis set (FAS) includes all participants who received study treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Trastuzumab Monotherapy | Participants received an initial dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor. |
| 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 | Progression-Free Survival (PFS) - Percentage of Participants With an Event | PFS was defined as the time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause. | FAS | Number | percentage of participants | Screening, every 3 months during treatment (up to 37 weeks), and at end of treatment |
|
|
Adverse events (AEs) and serious adverse events (SAEs) were recorded from study start to 30 days after the last dose of study drug.
All enrolled participants were included in the safety analysis.
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 | Trastuzumab Monotherapy | Participants received an initial dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain - stomach | General disorders | NCI CTC, version 2.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain - extremity, limb | General disorders | NCI CTC, version 2.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffman-LaRoche | 800-821-8590 | genentech@druginfo.com |
Not provided
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| ID | Term |
|---|---|
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068878 | Trastuzumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
The median time, in months, from the start of study treatment to an OS event. |
| Screening, every 4 weeks during treatment (up to 37 weeks), at end of treatment, and every 3 months thereafter |
| Percentage of Participants Surviving at 12 and 24 Months | Months 12 and 24 |
| Percentage of Participants by Best Overall Response to Treatment | Per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Complete response (CR) was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal [(short axis less than (<)10 millimeters (mm)]. No new lesions. Partial response (PR) was defined as greater than or equal to (≥)30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. Stable disease (SD) was defined as not qualifying for CR, PR, or progressive disease (PD). | Screening, every 3 months during treatment (up to 37 weeks), and at end of treatment |
| Dessau |
| 06846 |
| Germany |
| Fulda | 36043 | Germany |
| Leipzig | 04103 | Germany |
| Leipzig | 04277 | Germany |
| Marburg | 35043 | Germany |
| Weiden | 92637 | Germany |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Overall Survival (OS) - Percentage of Participants With an Event | OS was defined as the time from the start of study treatment to date of death due to any cause. | FAS | Number | percentage of participants | Screening, every 4 weeks during treatment (up to 37 weeks), at end of treatment, and every 3 months thereafter |
|
|
|
| Secondary | Overall Survival - Time to Event | The median time, in months, from the start of study treatment to an OS event. | FAS | Median | 95% Confidence Interval | months | Screening, every 4 weeks during treatment (up to 37 weeks), at end of treatment, and every 3 months thereafter |
|
|
|
| Secondary | Percentage of Participants Surviving at 12 and 24 Months | FAS | Number | 95% Confidence Interval | percentage of participants | Months 12 and 24 |
|
|
|
| Primary | Progression-Free Survival - Time to Event | The median time, in months, from the first study drug treatment to a PFS event. | FAS | Median | 95% Confidence Interval | months | Screening, every 3 months during treatment (up to 37 weeks), and at end of treatment |
|
|
|
| Secondary | Percentage of Participants by Best Overall Response to Treatment | Per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Complete response (CR) was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal [(short axis less than (<)10 millimeters (mm)]. No new lesions. Partial response (PR) was defined as greater than or equal to (≥)30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. Stable disease (SD) was defined as not qualifying for CR, PR, or progressive disease (PD). | FAS | Number | percentage of participants | Screening, every 3 months during treatment (up to 37 weeks), and at end of treatment |
|
|
|
| Primary | Percentage of Participants Progression Free at 12 and 24 Months | FAS | Number | 95% Confidence Interval | percentage of participants | Months 12 and 24 |
|
|
|
| 2 |
| 5 |
| 5 |
| 5 |
| Obstruction - GU | Renal and urinary disorders | NCI CTC, version 2.0 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | NCI CTC, version 2.0 | Non-systematic Assessment |
|
| Pain - headache | General disorders | NCI CTC, version 2.0 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | NCI CTC, version 2.0 | Non-systematic Assessment |
|
| Hypertension | Cardiac disorders | NCI CTC, version 2.0 | Non-systematic Assessment |
|
| Constitutional symptoms - other (not specified) | General disorders | NCI CTC, version 2.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | NCI CTC, version 2.0 | Non-systematic Assessment |
|
| Infection - other (not specified) | Infections and infestations | NCI CTC, version 2.0 | Non-systematic Assessment |
|
| Infection with unknown absolute neutrophil count (ANC) | Infections and infestations | NCI CTC, version 2.0 | Non-systematic Assessment |
|
| Metabolic/laboratory - other (not specified) | Metabolism and nutrition disorders | NCI CTC, version 2.0 | 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 that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D014570 | Urologic Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Title | Measurements |
|---|
|