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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-003121-25 | EudraCT Number | ||
| KDG-201 | Other Identifier | Kosan |
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The purpose of this study is to determine the anti-tumor activity (via objective response rate) of alvespimycin in patients with breast cancer who have not previously received trastuzumab (except as adjuvant therapy).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alvespimycin | Drug | Solution, IV, Alvespimycin 80 mg/m2, Weekly one hour infusion Days 1, 8, and 15, every 4 weeks thereafter until disease progression or DLT |
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| Measure | Description | Time Frame |
|---|---|---|
| Objective tumor response rate (either RECIST or WHO complete response, partial response or minor response) confirmed by CT and MRI as the preferred methods for tumor assessments and Chest x-ray is acceptable for pulmonary lesions | (all patients were off study by June 2008) | Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events assessed according to the NCI CTCAE (v 3.0) grading system | (all patients were off study by June 2008) | Within 28 days prior to the start of treatment, and for 167 days |
| Laboratory tests assessed according to the NCI CTCAE (v 3.0) grading system |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C448659 | 17-(dimethylaminoethylamino)-17-demethoxygeldanamycin |
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| Within 10 days prior to Cycle 1/1st infusion; within 48 hours of infusion (Cycle 1/Weeks 2/3/4 and Cycle 2+/Week3), or within 72 hours prior to infusion (Cycle 2+/Week 1) |
| Vital signs | (all patients were off study by June 2008) | Within 28 days prior to the start of treatment, Day1 of Weeks 1, 2, and 3 of Cycle 1 (4 weeks long), and prior to each 4-week cycle starting with Cycle 2, for 167 days |
| Karnofsky Performance Status | (all patients were off study by June 2008) | Within 28 days prior to the start of treatment, prior to each 4-week cycle starting with Cycle 2, for 167 days |
| Ocular testing | (all patients were off study by June 2008) | Within 28 days prior to the start of treatment, Cycle 1/Day 10 (3 days +/- 1 day following the 2nd infusion in the first cycle of therapy), prior to Cycle 2, if clinically indicated thereafter, for 167 days |
| Kaplan-Meier estimate of time to progression | (all patients were off study by June 2008) | Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days) |
| Time to progression on the patient's prior cytotoxic chemotherapy compared to the patient's time to progression on alvespimycin | (all patients were off study by June 2008) | Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days) |
| Kaplan-Meier estimate of progression-free survival | (all patients were off study by June 2008) | Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days) |
| Kaplan-Meier estimate of time to response | (all patients were off study by June 2008) | Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days) |
| Kaplan-Meier estimate of duration of response | (all patients were off study by June 2008) | Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days) |
| Kaplan-Meier estimate of time to treatment failure | (all patients were off study by June 2008) | Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days) |
| Kaplan-Meier estimate of overall survival | (all patients were off study by June 2008) | Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days) |
| Changes in tumor markers | Within 28 days prior to the start of treatment, Prior to each 4-week cycle starting with Cycle 2, for 167 days |
| Histopathological and molecular profile of responding and non-responding patients using paraffin-embedded surgical specimens | Specimens were obtained within 28 days prior to the start of treatment |
| D017437 |
| Skin and Connective Tissue Diseases |