A Multi-center, Double-blind, Randomized Phase III Clinical Trial of Chiauranib Plus Weekly Paclitaxel in Patients with Platinum-refractory or Platinum-resistant Recurrent Ovarian Cancer

Who is this study for? Patients with Ovarian Cancer
What treatments are being studied? Paclitaxel
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This randomized, double-blind, 2-arm study will evaluate the efficacy and safety of Chiauranib plus weekly paclitaxel versus placebo plus weekly paclitaxel in patients with Platinum-refractory or Platinum-resistant Recurrent ovarian cancer.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Willingness to sign a written informed consent document .

• Female, age ≥18 yrs and ≤70 yrs.

• Histological or cytological confirmation of epithelial ovarian cancer, carcinoma tube, or primary peritoneal carcinoma.

• Patients with platinum refractory or platinum resistant ovarian cancer:

‣ Platinum refractory: progression during the first platinum-based treatment or within 4 weeks after the first platinum-based primary therapy;

⁃ Platinum resistant: progression during the platinum-based treatment except for platinum refractory, or within 6 months after the last receipt of platinum-based treatment (patients have received platinum containing chemotherapy at least 4 weeks);

⁃ Radiological progression during the last treatment administered;

⁃ no more than 1 prior treatment regimens for recurrent disease.

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

• At least 1 lesion can be accurately measured, as defined by RECIST1.1.

• Laboratory criteria are as follows:

‣ Complete blood count: hemoglobin (Hb) ≥90g/L ; absolute neutrophil count (ANC) ≥1.5×109/L ; platelets ≥90×109/L;

⁃ Biochemistry test: serum creatinine(cr) \<1.5×ULN; total bilirubin\<1.5×ULN; alanine aminotransferase(ALT) ,aspartate aminotransferase(AST)≤2.5×ULN; (ALT,AST≦5×ULN if liver involved) ;

⁃ Coagulation test: International Normalized Ratio (INR) \< 1.5, activeated partial thromboplasting time (APTT) \<1.5×ULN

• Life expectancy of at least 3 months.

Locations
Other Locations
China
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Contact Information
Primary
Yu Chen
chenyu@chipscreen.com
8610-56102349
Time Frame
Start Date: 2021-12-20
Estimated Completion Date: 2025-07-31
Participants
Target number of participants: 454
Treatments
Experimental: Chiauranib plus weekly paclitaxel
Patients receive the combined treatment of chiauranib plus paclitaxel, 21 days for a cycle, 6 cycles at most,Chiauranib is given orally, 50mg once daily. Paclitaxel is given in intravenous infusion on Day 1, 8 and 15. After 6 cycles combined treatment, patients enter the single agent therapy of chiauranib.
Placebo_comparator: placebo plus weekly paclitaxel
Patients receive the combined treatment of placebo plus paclitaxel, 21 days for a cycle, 6 cycles at most,placebo is given orally, 50mg once daily. Paclitaxel is given in intravenous infusion on Day 1, 8 and 15. After 6 cycles combined treatment, patients enter the single agent therapy of placebo.
Authors
Related Therapeutic Areas
Sponsors
Leads: Chipscreen Biosciences, Ltd.

This content was sourced from clinicaltrials.gov

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