Status:
UNKNOWN
Anlotinib and Niraparib Dual Therapy Evaluation in Platinum-resistant Recurrent Ovarian Cancer
Lead Sponsor:
Jihong Liu
Conditions:
Platinum-resistant Ovarian Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
Brief Summary
At present, the standard treatment for platinum-resistant ovarian cancer patients is platinum-free chemotherapy, with poor efficacy and tolerance. The combination of anti-angiogenic drugs and PARPi ca...
Detailed Description
The present study is an open, single-center, prospective, single-arm phase II study to investigate the efficacy and safety of nilapalil combined with anrotidine in the treatment of platinum-resistant ...
Eligibility Criteria
Inclusion
- 1\. Subjects understand the trial process, sign informed consent, agree to participate in the study, and have the ability to follow the protocol; 2. 18 \~ 70 years old (inclusive), female; 3. Histologically diagnosed ovarian, fallopian tube, or primary peritoneal cancer; 4. Subjects were initially treated with platinum, and the disease recurrence occurred within 6 months after the end of the previous platinum-containing chemotherapy, that is, platinum resistance relapsed; 5. Life expectancy \> 16 weeks; 6. Patient's ECOG physical status score is 0-1; 7. Subject agrees to take blood samples for gBRCA mutations; 8. Can provide formalin-fixed, paraffin-embedded tumor tissue samples for sBRCA and homologous recombination repair-related genes detection (optional); 9. Good organ function, including:
- Neutrophil count \>= 1500 / μL;
- Platelets \>= 100,000 / μL;
- Hemoglobin \>= 9g / dL;
- Serum creatinine \<= 1.5 times the upper limit of normal value, or creatinine clearance \>= 60mL / min (calculated according to Cockcroft-Gault formula);
- Total bilirubin \<= 1.5 times the upper limit of normal value or direct bilirubin \<= 1.0 times the upper limit of normal value;
- AST and ALT \<= 2.5 times the upper limit of normal value. When liver metastases are present, it must be \<= 5 times the upper limit of normal value.
- 10\. The toxic side effects of any previous chemotherapy have recovered to \<= CTCAE level 1 or baseline levels, except for sensory neuropathy or hair loss with stable symptoms \<= CTCAE level 2.
Exclusion
- People who are known to be allergic to Niraparib or Anlotinib (or active or inactive ingredients of drugs with similar chemical structure);
- Symptomatic, uncontrolled brain or pia mater metastases;
- Underwent major surgery within 3 weeks before the study began or has not recovered after surgery;
- Received palliative radiotherapy of \> 20% bone marrow 1 week before enrollment;
- Have invasive cancer other than ovarian cancer (except fully treated basal or squamous cell skin cancer) within 2 years before enrollment;
- Patients with central lung squamous cell carcinoma or at risk for large hemoptysis;
- Previous or currently diagnosed myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML);
- Severe or uncontrolled diseases, including but not limited to: uncontrollable nausea and vomiting, inability to swallow or gastrointestinal diseases that may interfere with drug absorption and metabolism; active viral infections; mental illnesses that affect patients' signed informed consent History of bleeding tendency and thrombosis; history of severe cardiovascular disease;
- Laboratory abnormalities: hyponatremia; hypokalemia; uncontrollable nail function abnormalities;
- Receive platelet or red blood cell transfusions within 4 weeks;
- Patients who are pregnant or nursing, or who plan to become pregnant during study treatment;
- Have previously received any PARP inhibitor treatment.
Key Trial Info
Start Date :
May 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04376073
Start Date
May 22 2020
End Date
March 31 2022
Last Update
November 25 2020
Active Locations (1)
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1
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China, 510000