Overview

Anlotinib and Niraparib Dual Therapy Evaluation in Platinum-resistant Recurrent Ovarian Cancer

Status:
Recruiting
Trial end date:
2022-03-31
Target enrollment:
0
Participant gender:
Female
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 can play a synergistic anti-tumor role and achieve good efficacy in platinum-sensitive recurrent ovarian cancer. This study intends to explore the safety and effectiveness of anlotinib and niraparib dual therapy in patients with platinum-resistant recurrent ovarian cancer, fallopian tube cancer, and primary peritoneal cancer (ovarian cancer).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Jihong Liu
Treatments:
Niraparib
Criteria
Inclusion Criteria:

- 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 Criteria:

1. People who are known to be allergic to Niraparib or Anlotinib (or active or inactive
ingredients of drugs with similar chemical structure);

2. Symptomatic, uncontrolled brain or pia mater metastases;

3. Underwent major surgery within 3 weeks before the study began or has not recovered
after surgery;

4. Received palliative radiotherapy of > 20% bone marrow 1 week before enrollment;

5. Have invasive cancer other than ovarian cancer (except fully treated basal or squamous
cell skin cancer) within 2 years before enrollment;

6. Patients with central lung squamous cell carcinoma or at risk for large hemoptysis;

7. Previous or currently diagnosed myelodysplastic syndrome (MDS) or acute myeloid
leukemia (AML);

8. 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;

9. Laboratory abnormalities: hyponatremia; hypokalemia; uncontrollable nail function
abnormalities;

10. Receive platelet or red blood cell transfusions within 4 weeks;

11. Patients who are pregnant or nursing, or who plan to become pregnant during study
treatment;

12. Have previously received any PARP inhibitor treatment.