This clinical trial will evaluate the efficacy and safety of chiauranib added to chemotherapy in patients with relapsed or refractory ovarian cancer, in the meantime, explore the pharmacokinetics characteristic after the combined treatment.
This clinical trial will evaluate the efficacy and safety include adverse events, vital signs, laboratory tests, etc., of chiauranib added to chemotherapy (Paclitaxel/Etoposide) in patients with relapsed or refractory epithelial ovarian, fallopian tube or primary peritoneal cancer, in the meantime, explore the pharmacokinetics characteristic after the combined treatment.
Patients receive the combined treatment of chiauranib plus etoposide, 28 days for a cycle, 6 cycles at most. In the pilot trial, Chiauranib is given orally, 25mg once daily. After patients finish the blood collection for pharmacokinetics(PK), and if the efficacy and safety are acceptable, Chiauranib is given orally, 50mg once daily. Etoposide is given orally, 50mg once daily for 21 days, 7 days off, in the pilot and formal study. After 6 cycles combined treatment, patients enter the single agent therapy of chiauranib.
Patients receive the combined treatment of chiauranib plus paclitaxel, 21 days for a cycle, 6 cycles at most. In the pilot trial, Chiauranib is given orally, 25mg once daily. After patients finish the blood collection for pharmacokinetics(PK), and if the efficacy and safety are acceptable, Chiauranib is given orally, 50mg once daily. Paclitaxel is given in intravenous infusion on Day 1, 8 and 15, in the pilot and formal study. After 6 cycles combined treatment, patients enter the single agent therapy of chiauranib.
Histological or cytological confirmation of epithelial ovarian cancer, carcinoma tube, or primary peritoneal carcinoma.
patients are platinum-sensitive for the first time, then disease progression within 6 months of the last receipt of platinum-based chemotherapy.
Patients have received at least 1 platinum containing chemotherapy (at least 4 cycles), the disease has progressed or relapsed no more than 2 different chemotherapy regimens.
At least 1 lesion can be accurately measured, as defined by RECIST1.1.
The time for participants received anti-cancer therapy (including chemotherapy, radiotherapy, immunotherapy and surgical therapy, et al) should be more than 4 weeks before enrollment; The time for participants received mitomycin chemotherapy should be more than 6 weeks before enrollment.
Coagulation test: International Normalized Ratio (INR) < 1.5.
Willingness to sign a written informed consent document.
Congestive heart failure, unstable angina pectoris, myocardial infarction within 6 months prior to study entry; arrhythmia, or Left Ventricular Ejection Fraction (LVEF) < 50% requiring treatment with agents during screening stage.
Uncontrolled hypertension (≥ 140/90 mmHg) by single agent.
Serologically positive for HIV, hepatitis B or C, or other serious infectious diseases (positive infectious diseases refer to that needed systemic therapy; HIV, hepatitis B or C: qualitative detection priority, quantitative detection if needed).
History of interstitial lung disease (ILD).
Candidate with drug and alcohol abuse (alcohol abuse: alcohol consumption is no more than 5040ml beer or 2100ml wine or 630ml strong wine with alcohol content tops out at 40 percent each week).
Participants of reproductive potential not willing to use adequate contraceptive measures for the duration of the study (both male and female participants).Pregnant or breastfeeding women. Female participants must have a negative urinary or serum pregnancy test when done or have evidence of post-menopausal status (Defined as absence of menstruation for greater than 12 months, bilateral oophorectomy or hysterectomy).
Any other condition which is inappropriate for the study in the opinion of the investigators.
Responsible Party: Chipscreen Biosciences, Ltd.