Phase Ib Study of Chiauranib in Patients With Ovarian Cancer

NCT03166891 | Completed Phase 1

• 1 other identifier: CAR102
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Chiauranib may stop the growth of tumor cells by blocking Aurora kinase B（Aurora B）、VEGFR/PDGFR/c-Kit、CSF-1R targets. This clinical trial is studying the efficacy and safety of chiauranib(50mg，QD，PO) works in treating patients with relapsed or refractory ovarian cancer, in the meantime, exploring the latent biomarkers accompany with chiauranib, as well as the relevancy of which and clinical benefit.

Conditions

Ovarian Cancer

Keywords

ovarian cancer, relapsed or refractory,chiauranib

Outcome Measures

Primary Outcomes (1)

• Overall response rate(ORR)

  ORR will be calculated from the data obtained from the end visit

  assessed up to 2 years

Secondary Outcomes (6)

• Number of participants with treatment-related adverse events

  measured through 2 years

• Progression-free survival (PFS)

  assessed up to 2 years

• Time to progression(TTP)

  through treatment completion, up to 2 years

• Duration of response (DOR)

  assessed up to 2 years

• Overall survival(OS)

  assessed up to 2 years

Other Outcomes (3)

• immunohistochemical(IHC) staining results of Aurora B、CSF-1R and Myc protein

  assessed up to 2 years

• Any single mutation of oncogene and copy number variation in ctDNA(single gene analysis)

  assessed up to 2 years

• Mutation of polygene and copy number variation in signal pathway(multi-gene analysis)

  assessed up to 2 years

Study Arms (1)

chiauranib

EXPERIMENTAL

Patients take Chiauranib capsules 50mg, orally once daily, 28 days as a cycle.

Drug: Chiauranib

Interventions

Chiauranib DRUG

Take 50mg orally once daily

Also known as: CS2164

chiauranib

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 tubae, or primary peritoneal carcinoma.
• Patients have received platinum containing chemotherapy, a) platinum resistant disease (disease progression within 6 months of the last receipt of platinum-based chemotherapy), the disease has progressed or relapsed after at least 2 different chemotherapy regimens; b) platinum sensitive disease (disease progression after 6 months of the last receipt of platinum-based chemotherapy), the disease has progressed or relapsed at least 2 different chemotherapy regimens, or the patients refuse any chemotherapy.
• At least 1 lesion can be accurately measured, as defined by RECIST1.1.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• Subjects received anti-cancer therapy (including chemotherapy, radiotherapy, immunotherapy and surgical therapy, et al) should beyond 4 weeks prior to study entry; Subjects received mitomycin chemotherapy should beyond 6 weeks prior to study entry.
• 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: total bilirubin≦1.5×ULN; alanine aminotransferase(ALT) ,aspartate aminotransferase(AST)≦1.5×ULN; (ALT,AST≦5×ULN if liver involved) ;serum creatinine(cr)≦1.5×ULN; Coagulation test: International Normalized Ratio (INR) \< 1.5.
• Life expectancy of at least 12 weeks.
• Willingness to sign a written informed consent document.

You may not qualify if:

• Patients with prior invasive malignancies with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or cervical carcinoma in situ, unless received curative treatment and with documented evidence of no recurrence in the past five years;
• 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;
• Have unsolved toxicities (\> grade 1) from prior anti-cancer therapy;
• Have clinical significant gastrointestinal abnormality, e.g., unable to swallow, chronic diarrhea, ileus, that would impair the ingestion,transportation or absorption of oral agents, or patients undergone gastrectomy.
• History of organ transplantation.
• Major surgery within 6 weeks and minor surgery within 2 weeks prior to screening (excluding placement of vascular access or biopsy) that involved general anaesthesia or respiratory assistance.

Sponsors & Collaborators

• Chipscreen Biosciences, Ltd.: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 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

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2017
• First Posted: May 25, 2017
• Study Start: December 15, 2017
• Primary Completion: March 20, 2019
• Study Completion: March 20, 2019
• Last Updated: January 18, 2020

Record last verified: 2019-07

Locations

CN (1)