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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
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The purpose of this study is to investigate the effect of combined topotecan and veliparib (ABT888) treatment in relapsed ovarian cancer with tumor progression and negative or unknown BRCA mutation status.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Veliparib and Topotecan | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Veliparib | Drug | Veliparib (tablet) twice daily on days 1-3, 7-9, and 14-16 in a 28 days cycle. In phase I the starting dose is 30 mg x 2. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase I: Maximum tolerated dose, dose limiting toxicity and thus recommend phase II dose of veliparib | 1 month | |
| Phase II: To investigate response rates (based on either CA125 GCIG or RECIST criteria) of combination topotecan and veliparib (ABT888) in relapsed ovarian cancer with negative or unknown BRCA status | Every three months, up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival of ovarian cancer patients treated with topotecan and veliparib | Every three months up to three years | |
| Overall survival of ovarian cancer patients treated with topotecan and veliparib | Every three months, up to three years |
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Inclusion Criteria:
Histologically confirmed epithelial, primary fallopian or primary peritoneal cancer.
Verified progression by either RECIST criteria and/or GCIG CA125 criteria after previous first line chemotherapy or progression after later lines of cytotoxic treatment.
Platinum resistance or partially platinum sensitive disease
Age ≥ 18 years.
Performance status 0-2.
Measurable disease by RECIST 1.1 or CA125 GCIG criteria
Adequate bone marrow function, liver function, renal function and coagulation parameters (within 7 days prior to enrollment):
Written informed consent.
Tissue available for BRCAness analysis/BRCA mutation analysis.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anders Jakobsen, MD, DMSc | Vejle Hospital | Study Chair |
| Hanne Kanstrup, MD | Vejle Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oncology, Vejle Hospital | Vejle | DK-7100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30104007 | Derived | Hjortkjaer M, Kanstrup H, Jakobsen A, Steffensen KD. Veliparib and topotecan for patients with platinum-resistant or partially platinum-sensitive relapse of epithelial ovarian cancer with BRCA negative or unknown BRCA status. Cancer Treat Res Commun. 2018;14:7-12. doi: 10.1016/j.ctarc.2017.09.001. Epub 2017 Sep 27. No abstract available. |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| C521013 | veliparib |
| D019772 | Topotecan |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Topotecan | Drug | 2 mg/m² iv over 30 minutes on days 2, 8, and 15 in cycles of 28 days. Topotecan is dosed at a maximum body surface area of 2 m². |
|
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |