Chiauranib Plus Weekly Paclitaxel in Patients with Platinum-refractory or Platinum-resistant Recurrent Ovarian Cancer

NCT04921527 | Recruiting Phase 3 DMC

• 1 other identifier: CAR301
• Study Type: interventional
• Target: 454
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ovarian Cancer; Relapsed or Refractory; Chiauranib; Paclitaxel

Outcome Measures

Primary Outcomes (2)

• progression-free survival (PFS)

  From the first time of treatment until the date of first documented progression or date of death from any cause, whichever comes first (Assessed by IRC)

  assessed up to 1 years

• overall survival (OS)

  OS is defined as the length of time from treatment to death from any cause

  assessed up to 2 years

Secondary Outcomes (6)

• overall response rate (ORR)

  assessed up to 2 years

• duration of response (DOR)

  assessed up to 2 years

• Disease control rate (DCR)

  assessed up to 2 years

• Quality of life (QoL)

  assessed up to 2 years

• Toxicity according to NCI CTCAE v5.0 criteria

  assessed up to 2 years

Study Arms (2)

Chiauranib plus weekly paclitaxel

EXPERIMENTAL

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.

Drug: chiauranib; Drug: Paclitaxel

placebo plus weekly paclitaxel

PLACEBO COMPARATOR

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.

Drug: Placebo; Drug: Paclitaxel

Interventions

chiauranib DRUG

50mg orally once daily

Also known as: CS2164

Chiauranib plus weekly paclitaxel

Placebo DRUG

50mg orally once daily

placebo plus weekly paclitaxel

Paclitaxel DRUG

at the first cycle, 60mg/m2, i.v infusion on day 1, 8 and 15 ; at the begining of the second cycle, after a comprehensive assessment , investigators decide whether to increase the dosage to 80mg/m2, i.v infusion on day 1, 8 and 15 ;

Also known as: Anzatax

Chiauranib plus weekly paclitaxel; placebo plus weekly paclitaxel

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients received vascular endothelial growth factor(VEGF)/vascular endothelial growth factor receptor(VEGFR) inhibitor, like Apatinib, Anlotinib, Fruquintinib, Bevacizumab, etc., or Aurora kinase inhibitors.
• Patients received weekly paclitaxel therapy.
• Has known allegies to Chiauranib, paclitaxel or any of the excipients.
• Biological therapy, immunotherapy, hormonal therapy within 28 days prior to the first dose of study drug.
• prior major surgery or trauma within 14 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer.
• Treatment with an investigational agent/instrument within 28 days prior to first dose of study drug.
• Any ongoing toxicity from prior anti-cancer therapy that is \>Grade 1.
• Patients with prior invasive malignancies in the past five years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or cervical carcinoma in situ.
• History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis.
• clinically significant central/peripheral nervous system disease.
• Have uncontrolled or significant cardiovascular disease, including:
• 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.
• primary cardiomyopathy(dilated cardiomyopathy, hypertrophic cardiomyocyte, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, et,al)
• History of significant QT interval prolongation, or Corrected QT Interval (QTc) \> 470 ms prior to study entry
• Symptomatic coronary heart disease requiring treatment with agents

Sponsors & Collaborators

• Chipscreen Biosciences, Ltd.: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China, 200032, China

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms; Recurrence

Interventions

chiauranib; Paclitaxel

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Xiaohua Wu

  Fudan university Shanghai cancer centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu Chen

CONTACT

8610-56102349; chenyu@chipscreen.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: June 10, 2021
• Study Start: December 20, 2021
• Primary Completion: December 31, 2024
• Study Completion: July 31, 2025
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)