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A Study of Niraparib in Combination With Brivanib in Recurrent Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT03895788
Recruitment Status : Recruiting
First Posted : March 29, 2019
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
Hunan Cancer Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: niraparib Drug: Brivanib Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Single-Arm, Phase I Clinical Trial to Evaluate the Safety and Tolerability of ZL-2306 (Niraparib) in Combination With Brivanib in Patients With Recurrent Ovarian Cancer
Actual Study Start Date : January 14, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2020


Arm Intervention/treatment
Experimental: niraparib and brivanib
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.
Drug: niraparib
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.

Drug: Brivanib
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.




Primary Outcome Measures :
  1. Maximum tolerated dose [ Time Frame: 1 year ]
    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).


Secondary Outcome Measures :
  1. Assess the toxicity of the combination of niraparib and brivanib in each cohort by number of participants with treatment related adverse events [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed informed consent .
  2. Female, age ≥ 18 years.
  3. Histologically confirmed diagnosis of ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
  4. Patients must have ovarian cancer and have failed at least 1 prior line of therapy
  5. Life expectancy of more than 16 weeks.
  6. ECOG 0-1.
  7. Patient agrees to blood draws during study for the gBRCA test
  8. Has good organ function, including:

    • Absolute neutrophil count ≥1,500/µL
    • Platelets ≥125,000/µL
    • Hemoglobin ≥10 g/dL
    • Serum creatinine ≤1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥60 mL/min using the Cockcroft-Gault equation
    • Total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤1 x ULN
    • Aspartate aminotransferase and alanine aminotransferase ≤2.5 x ULN unless liver metastases are present, in which case they must be ≤5 x ULN
  9. 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):

    • ≥45 years and <60 years of age and has not had menses for >1 year
    • ≥60 years of age
    • Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation.
  10. Is able to adhere to the protocol.
  11. 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:

  1. Has a known hypersensitivity to the active or inactive ingredients of ZL-2306 (niraparib) or compound which has similar chemical structure to ZL-2306 (niraparib).
  2. Has a known hypersensitivity to the active or inactive ingredients of brivanib or compound which has similar chemical structure to brivanib.
  3. Has symptomatic uncontrolled brain or leptomeningeal metastasis.
  4. Major surgery or chemotherapy within 3 weeks of starting the study or patient has not recovered from any effects of the surgery.
  5. Receive palliative radiotherapy encompassing > 20% of the bone marrow within 1 week of entering the study.
  6. Be diagnosed any invasive cancer other than ovarian cancer (apart from cured basal cell carcinoma and squamous cell carcinoma) within 2 years prior to study enrolment.
  7. Patient must has any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)
  8. Has other serious or uncontrolled disease
  9. Has any disease, treatment and laboratory abnormality that may interfere the study results and affect the fully attendance of study. Or the patient is considered to be not suitable for the study by the investigator. Cannot receive platelet or red blood cell transfusion within 4 weeks of study drug administration.
  10. Pregnant, breastfeeding or expecting to conceive children during the study treatment period.
  11. Corrected QT (QTc) interval > 450 msec.
  12. Prior PARP inhibitor therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03895788


Contacts
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Contact: Jing Wang +86-18908482599 wangjing189@163.com

Locations
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China, Hunan
Jing Wang Recruiting
Changsha, Hunan, China
Contact: Jing Wang, MD    +86-18908482599 ext +8618908482599    wangjing189@163.com   
Sponsors and Collaborators
Hunan Cancer Hospital

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Responsible Party: Hunan Cancer Hospital
ClinicalTrials.gov Identifier: NCT03895788     History of Changes
Other Study ID Numbers: CH1809001
First Posted: March 29, 2019    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Niraparib
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents