Phase I Study of Chiauranib in Patients With Advanced Solid Tumors

NCT02122809 | Completed Phase 1

• 1 other identifier: CAR101
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this dose-escalation study is to assess the safety and tolerability of treatment with Chiauranib administered orally over a range of doses in patients with advanced solid tumors.

Conditions

Solid Tumors

Keywords

Chiauranib, advanced solid tumors, phase 1 study

Outcome Measures

Primary Outcomes (2)

• dose-limiting toxicity (DLT)

  day 1-28

• Number of Adverse Events

  An expected average of 8 months

Secondary Outcomes (3)

• pharmacokinetic profile of Chiauranib

  On day 1,8,15,22,25,26,27,28

• Evidence of benefit

  An expected average of 8 months

• Pharmacodynamic profile of Chiauranib

  On day 15,28

Study Arms (1)

Chiauranib

EXPERIMENTAL

Patients take a single dose of Chiauranib capsules for the pharmacokinetic study,then off for 5 days before the first cycle begins. In the subsequent treatment cycles, Chiauranib capsules are given orally once daily, 28 days as a cycle.

Drug: Chiauranib

Interventions

Chiauranib DRUG

Take orally

Also known as: CS2164

Chiauranib

Eligibility Criteria

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

You may qualify if:

• Histological or cytological confirmation of advanced solid tumor, including non-small cell lung cancer, colorectal cancer, ovarian cancer, renal cell carcinoma, gastrointestinal stromal tumor, gastric cancer, et al;
• Patients with advanced solid tumors refractory to standard therapy or for which no standard therapy exists;
• Body mass index (BMI) is between 18 and 28;
• Age: 18\~65 years;
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
• Laboratory criteria are as follows:
• Complete blood count: hemoglobin (Hb) ≥100g/L (no blood transfusion within 14 days); absolute neutrophil count (ANC) ≥1.5×109/L ; platelets \>=100×109/L
• Biochemistry test: serum creatinine \<=1.5×upper limit of normal (ULN); total bilirubin≦1.5×ULN; alanine aminotransferase / aspartate aminotransferase≦1.5×ULN; fasting triglyceride (TG) \<= 3.0 mmol/L; total cholesterol \<= 7.75 mmol/L
• Coagulation test: International Normalized Ratio (INR) \< 1.5
• Women of child-bearing potential should be non-lactating patients, and must agree to use effective contraceptive methods prior to study entry, during study participation, and up to 6 months following completion of therapy. A serum or urine pregnancy test within 7 days before enrollment must be negative; Men must agree to use effective contraceptive methods during study participation and up to 6 months following completion of therapy;
• Willingness to sign a written informed consent document

You may not qualify if:

• Life expectation \< 3 months;
• Subjects received anti-cancer therapy (including chemotherapy, radiotherapy, targeted therapy and endocrine therapy, et al) within 4 weeks prior to study entry; Subjects received nitrosoureas or mitomycin chemotherapy within 6 weeks prior to study entry;
• Have uncontrolled or significant cardiovascular disease, including:
• Myocardial infarction (\< the last 12 months)
• Uncontrolled angina (\< the last 6 months)
• Congestive heart failure (\< the last 6 months), or Left Ventricular Ejection Fraction (LVEF) \< 50% prior to study entry
• History of any significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, or TdP)
• History of significant QT interval prolongation, or Corrected QT Interval (QTc) \> 450 ms prior to study entry
• History of cerebrovascular accident
• Symptomatic coronary heart disease requiring treatment with agents
• Uncontrolled hypertension (\> 140/90 mmHg) by single agent;
• Have active bleeding , current thrombotic disease, or patients with bleeding potential receiving anticoagulation therapy;
• 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;

Sponsors & Collaborators

• Chipscreen Biosciences, Ltd.: lead

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

Related Publications (1)

• Sun Y, Yang L, Hao X, Liu Y, Zhang J, Ning Z, Shi Y. Phase I dose-escalation study of chiauranib, a novel angiogenic, mitotic, and chronic inflammation inhibitor, in patients with advanced solid tumors. J Hematol Oncol. 2019 Jan 14;12(1):9. doi: 10.1186/s13045-018-0695-0.

  PMID: 30642372 DERIVED

MeSH Terms

Interventions

chiauranib

Study Officials

• Yuankai Shi

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

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: April 22, 2014
• First Posted: April 25, 2014
• Study Start: February 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 17, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)