Phase Ib/II Study of Chiauranib in Patients With Small Cell Lung Cancer

NCT03216343 | Completed Phase 1

• 1 other identifier: CAR105
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Chiauranib , which simultaneously targets against VEGFR/Aurora B/CSF-1R, several key kinases involved in tumor angiogenesis, tumor cell mitosis, and chronic inflammatory microenvironment.

Conditions

Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Objective reponse rate(ORR)

  ORR is defined as the percentage of participants whose best overall response is either complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

  Up to a minimum 24 weeks after the last participant's first dose, or progression, or 75% subjects died.

Secondary Outcomes (6)

• Number of subjects with Adverse Events as a Measure of Safety and Tolerability

  Up to a minimum 28 weeks after the last participant's first dose, or progression, or 75% subjects died.

• Disease-control rate (DCR)

  Up to a minimum 24 weeks after the last participant's first dose, or progression, or 75% subjects died.

• Time to progression(TTP)

  From date of the first dose of study drug until the date of first documented progression NOT including death, assessed up to 24 months

• Duration of response (DOR)

  from the date of first documented objective response until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

• Progression-free survival (PFS)

  From date of the first dose of study drug until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

Other Outcomes (3)

• Median score of immunohistochemical expressed by Aurora B、CSF-1R and Myc protein.

  assessed up to 24 months

• Screening characteristics of ctDNA measurement (single gene analysis).

  assessed up to 24 months

• Screening characteristics of ctDNA measurement (multi-gene analysis).

  assessed up to 24 months

Study Arms (1)

Study Arm

EXPERIMENTAL

Patients take Chiauranib capsules 50mg, orally once daily, 28 days as a cycle until objective disease progression

Drug: Chiauranib

Interventions

Chiauranib DRUG

CS2164

Study Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age ≥ 18 years and ≤75 years;
• Cytologically or histologically confirmed small cell lung cancer;
• Patients have received at least 2 different systemic chemotherapy regimens (contained platinum based regimen) , and progressed or relapsed
• At least one measurable lesion that can be accurately assessed ( RECIST1.1 criteria). If the only site of measurable disease is in a previously irradiated area, the patient must have documented progression of disease in this area.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• Laboratory criteria are as follows:
• Complete blood count: hemoglobin (Hb) ≥80g/L ; absolute neutrophil count (ANC) ≥1.5×109/L ; platelets \>=75×109/L Biochemistry test: total bilirubin≦1.5×ULN; alanine aminotransferase(ALT) ,aspartate aminotransferase(AST)≦2.5×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.
• All patients must have given signed, informed consent prior to registration on study.

You may not qualify if:

• Patients receiving any anti-cancer therapy (including chemotherapy, target therapy, immunotherapy, radiotherapy, and anti-cancer Chinese traditional medicine, et al) within 4 weeks from the last dose prior to study entry; Subjects receiving any supportive treatment for haematology (including transfusion, blood products, or drugs that stimulate blood cells growth like G-CSF, et al) within 2 weeks from the last dose prior to study entry;
• Patients with second primary cancer, except: adequately treated basal cell or squamous cell skin cancer, curatively treated in-situ cancer of the cervix, unless received curative treatment and with documented evidence of no recurrence during the past five years;
• Patients with uncontrolled or significant cardiovascular disease, including:
• A) Grade II or higher Congestive heart failure, unstable angina pectoris, myocardial infarction (NYHA Classification) within 6 months prior to study entry; or arrhythmia requiring treatment, or Left Ventricular Ejection Fraction (LVEF) \< 50% during screening stage.
• B) Primary cardiomyopathy (dilated cardiomyopathy, hypertrophic cardiomyocyte, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, et,al).
• C) History of significant QT interval prolongation, or Corrected QT Interval QTc≥450ms(male),QTc≥470ms（female）at screening.
• D) Symptomatic coronary heart disease requiring treatment. E) Uncontrolled hypertension (\> 140/90 mmHg) with single medication.
• History of active bleeding within 6 months prior to screening; or patients receiving anticoagulation therapy; or patients with upper GI bleeding potential; or patients with active hemoptysis.
• Patients with uncontrolled pleural effusion, pericardial effusion or ascites.
• Patients with untreated central nervous system (CNS) metastasis; or requiring corticosteroids, anticonvulsants for CNS diseases treatment; or with evidence of progression or haemorrhage within 1 month prior to study entry; or clinical evidence of brain stem or leptomeninx involvement.
• History of deep vein thrombosis or pulmonary embolism.
• History of interstitial lung disease(ILD).
• With the exception of alopecia, any ongoing toxicities (\>CTCAE grade 1) caused by previous cancer therapy.
• Patients with factors that could affect oral medication (such as dysphagia，chronic diarrhea, intestinal obstruction etc), or undergone gastrectomy. .
• weeks or less from the last major surgery that involved general anaesthesia, or 2 weeks or less from the last minor surgery prior to screening (excluding placement of vascular access ) .

Sponsors & Collaborators

• Chipscreen Biosciences, Ltd.: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

chiauranib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

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: July 10, 2017
• First Posted: July 13, 2017
• Study Start: November 9, 2017
• Primary Completion: November 4, 2022
• Study Completion: May 15, 2023
• Last Updated: August 30, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)