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Open-label, cohort study to determine the safety and tolerability of the combination of daily niraparib and daily brivanib for one 28-day cycle in patients with advanced ovarian cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| niraparib and brivanib | Experimental | Subjects will be assigned into niraparib 100mg+brivanib 200mg, niraparib 200mg+brivanib 200mg, niraparib 200mg+brivanib 400mg, niraparib 200mg+brivanib 600mg dose group at the first day of the first cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| niraparib | Drug | Niraparib will be administered as a flat-fixed dose (100mg or 200 mg, daily) depending on the cohort the patient is enrolled to, and not by body weight or body surface area. Each dose should be swallowed whole without chewing. The consumption of water is permissible. Patients should take doses at approximately the same times each day, and record this information in the patient diary. Patients will be provided with a diary in which to record their intake of study drug. However, the actual number of doses taken by the patient must be calculated from the number of tablets dispensed and returned. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose | To determine the maximum tolerated dose of the combination of niraparib and brivanib for the treatment of patients with advanced ovarian cancer. The maximum tolerated dose (MTD) that is defined as the dose level at which less than one-third of patients will experience a dose-limiting toxicity (DLT). | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the toxicity of the combination of niraparib and brivanib in each cohort by number of participants with treatment related adverse events | 1 year |
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Inclusion Criteria:
Signed informed consent .
Female, age ≥ 18 years.
Histologically confirmed diagnosis of ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
Patients must have ovarian cancer and have failed at least 1 prior line of therapy
Life expectancy of more than 16 weeks.
ECOG 0-1.
Patient agrees to blood draws during study for the gBRCA test
Has good organ function, including:
Female patient has a negative serum pregnancy test within 3 days prior to taking study treatment if of childbearing potential and agrees to abstain from activities that could result in pregnancy from screening through 3 months after the last dose of study treatment, or is of non-childbearing potential. Non-childbearing potential is defined as follows (by other than medical reasons):
Is able to adhere to the protocol.
Has recovered from previous chemotherapy induced toxic side effects to ≤ grade 1 CTCAE or basal level, apart from ≤ grade 2 CTCAE peripheral neuropathy or hair loss symptoms at steady state.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Wang | Contact | +86-18908482599 | wangjing189@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jing Wang | Recruiting | Changsha | Hunan | China |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| C545685 | niraparib |
| C509922 | brivanib |
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| Brivanib | Drug | Brivanib will be administered as a flat-fixed dose (200mg, 400 mg, or 600 mg daily) depending on the cohort the patient is enrolled to, and not by body weight or body surface area. |
|
| 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 |