Chiauranib in Combination With Chemotherapy in Patients With Ovarian Cancer

NCT03901118 | Completed Phase 2

• 1 other identifier: CAR201
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ovarian Cancer

Keywords

ovarian cancer, relapsed or refractory; chiauranib, chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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 up to 1 years

Secondary Outcomes (4)

• overall response rate (ORR)

  assessed up to 2 years

• overall survival (OS)

  assessed up to 2 years

• time to progression(TTP)

  assessed up to 2 years

• duration of response (DOR)

  assessed up to 2 years

Study Arms (2)

chiauranib plus etoposide

EXPERIMENTAL

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.

Drug: chiauranib; Drug: etoposide

chiauranib plus paclitaxel

EXPERIMENTAL

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.

Drug: chiauranib; Drug: paclitaxel

Interventions

chiauranib DRUG

in the phase of pilot trial, 25mg orally once daily; in the formal phase, 50mg orally once daily

Also known as: CS2164

chiauranib plus etoposide; chiauranib plus paclitaxel

etoposide DRUG

50mg orally once daily for 21 days, 7 days off, every 28 days for a cycle, 6 cycles at most

Also known as: Lastet

chiauranib plus etoposide

paclitaxel DRUG

60mg/m2, i.v infusion on day 1, 8 and 15, every 21 days for a cycle, 6 cycles at most

Also known as: Anzatax

chiauranib plus 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:

• Female, aged ≥ 18 yrs and ≤70 yrs;
• Histological or cytological confirmation of epithelial ovarian cancer, carcinoma tube, or primary peritoneal carcinoma.
• Patients with platinum-resistant or platinum-refractory ovarian cancer,
• platinum-resistant disease (disease progression within 6 months of the last receipt of platinum-based chemotherapy);
• platinum-refractory disease (disease progression during the period of platinum-based chemotherapy);
• 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.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• 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.
• 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.
• Life expectancy of at least 3 months.

You may not qualify if:

• 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;
• Patients with allergic to Chiauranib, Etoposide and Paclitaxel;
• 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 Etoposide therapy;
• Patients received weekly Paclitaxel therapy ;
• Clinical evidence of central nervous system involvement;
• 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
• Uncontrolled hypertension (≥ 140/90 mmHg) by single agent.
• Have active bleeding current thrombotic disease, patients with bleeding potential ,or receiving anticoagulation therapy; within 2 months prior to screening;
• Proteinuria positive (≥1g/24h).
• History of deep vein thrombosis or pulmonary embolism;

Sponsors & Collaborators

• Chipscreen Biosciences, Ltd.: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

Location

Related Publications (1)

• Li J, Liu J, Yin R, Zou D, Zheng H, Cao J, Chen Z, Sun W, Gao Y, Zhang S, Zeng L, An R, Lu X, Ye S, Wu X. Efficacy and safety of chiauranib in a combination therapy in platinum-resistant or refractory ovarian cancer: a multicenter, open-label, phase Ib and II study. Mol Cancer. 2024 Aug 9;23(1):162. doi: 10.1186/s12943-024-02076-x.

  PMID: 39123210 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms; Recurrence

Interventions

chiauranib; Etoposide; 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)

Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes

Study Officials

• Xiaohua Wu

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2019
• First Posted: April 3, 2019
• Study Start: July 1, 2019
• Primary Completion: December 18, 2020
• Study Completion: December 18, 2020
• Last Updated: March 19, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)