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This is a multicenter, open label extension study. Subjects who have completed treatment in the parent study of pertuzumab, either alone or with a combination agent, and who received at least one dose of pertuzumab in the parent study are eligible for inclusion in this trial if they are continuing to receive clinical benefit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pertuzumab | Experimental | Participants received the same dose of pertuzumab that they received in their parent Phase II trial, either 420 mg or 1050 mg, intravenously on Day 1 of every 3 week cycle until disease progression. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pertuzumab | Drug | Pertuzumab was supplied as a single-use liquid formulation. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Experienced an Adverse Event | Baseline to the end of the study (up to 2 years, 5 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD) | A best overall response could occur at any time during the study and was determined by Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target lesions (TL) or the disappearance of all non-TLs and normalization of tumor marker level. A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD. SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since the treatment started for TLs and the persistence of 1 or more non-TL(s) and/or the maintenance of tumor marker level above normal limits. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started or the appearance of one or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mika Derynck, M.D. | Genentech, Inc. | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pertuzumab | Participants received the same dose of pertuzumab that they received in their parent Phase II trial, either 420 mg or 1050 mg, intravenously on Day 1 of every 3 week cycle until disease progression. Pertuzumab: Pertuzumab was supplied as a single-use liquid formulation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Safety population: Participants who received at least 1 dose of pertuzumab.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pertuzumab | Participants received the same dose of pertuzumab that they received in their parent Phase II trial, either 420 mg or 1050 mg, intravenously on Day 1 of every 3 week cycle until disease progression. Pertuzumab: Pertuzumab was supplied as a single-use liquid formulation. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Who Experienced an Adverse Event | Safety population: Participants who received at least 1 dose of pertuzumab. Percentage of participants | Posted | Number | percentage of participants | Baseline to the end of the study (up to 2 years, 5 months) |
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Safety population: Participants who received at least 1 dose of pertuzumab.
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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 | Pertuzumab | Participants received the same dose of pertuzumab that they received in their parent Phase II trial, either 420 mg or 1050 mg, intravenously on Day 1 of every 3 week cycle until disease progression. Pertuzumab: Pertuzumab was supplied as a single-use liquid formulation. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| EJECTION FRACTION DECREASED | Investigations | MedDRA (10.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Genentech, Inc. | 800 821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| C485206 | pertuzumab |
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| Baseline to the end of the study (up to 2 years, 5 months) |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Secondary | Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD) | A best overall response could occur at any time during the study and was determined by Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target lesions (TL) or the disappearance of all non-TLs and normalization of tumor marker level. A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD. SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since the treatment started for TLs and the persistence of 1 or more non-TL(s) and/or the maintenance of tumor marker level above normal limits. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started or the appearance of one or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. | Safety population: Participants who received at least 1 dose of pertuzumab. | Posted | Number | percentage of participants | Baseline to the end of the study (up to 2 years, 5 months) |
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| 0 |
| 3 |
| 1 |
| 3 |
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.
| Title | Measurements |
|---|---|
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| Progressive disease |
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| Unknown |
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