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| Name | Class |
|---|---|
| Roche Pharma AG | INDUSTRY |
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This is a single centre, 3+3, dose finding, open label, phase 1b clinical study of carboplatin and cyclophosphamide, in combination with atezolizumab.
The starting dose is carboplatin AUC 5mg/ml*min, cyclophosphamide 600mg/m2 and atezolizumab 840 mg, all administered intravenously. One cycle is 28 days. On day 1 carboplatin, cyclophosphamide and atezolizumab will be administered. On day 15 atezolizumab only will be administered. Patients will be treated until loss of clinical benefit, unacceptable toxicities, or withdrawal of consent. It is expected that 6-12 patients will be enrolled, depending on safety issues observed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| carbo, cyclo, atezolizumab | Experimental | The starting dose is carboplatin AUC 5mg/ml*min (d1), cyclophosphamide 600mg/m2(d1) and atezolizumab 840 mg (D1, 15), all administered intravenously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carbplatin, cyclophophamide, atezolizumab | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity; Incidence of toxicity, graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4.03 | Adverse events will be graded according to NCI Common Toxicity Criteria version 4.03 | up to 30 days after end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | Tumor response will be measured according to the RECIST 1.1 criteria | assessed up to 120 months |
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Inclusion Criteria:
Exclusion Criteria:
Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RN
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antoni van Leeuwenhoek | Amsterdam | Netherlands |
to be determined
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| D010051 | Ovarian Neoplasms |
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C000594389 | atezolizumab |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |