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Phase I Study of Chiauranib in Patients With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT02122809
Recruitment Status : Completed
First Posted : April 25, 2014
Last Update Posted : June 17, 2016
Sponsor:
Information provided by (Responsible Party):
Chipscreen Biosciences, Ltd.

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.

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: Chiauranib Phase 1

Detailed Description:
The purpose of this study is to assess the tolerability and safety include adverse events, vital signs, laboratory tests ,etc., of a range of doses of Chiauranib in solid tumor patients, and to determine the dose limit toxicity and the maximum tolerable dose.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Safety and Pharmacokinetics Study of Chiauranib in Patients With Advanced Solid Tumors
Study Start Date : February 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : June 2016

Arm Intervention/treatment
Experimental: Chiauranib
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
Take orally
Other Name: CS2164




Primary Outcome Measures :
  1. dose-limiting toxicity (DLT) [ Time Frame: day 1-28 ]
  2. Number of Adverse Events [ Time Frame: An expected average of 8 months ]

Secondary Outcome Measures :
  1. pharmacokinetic profile of Chiauranib [ Time Frame: On day 1,8,15,22,25,26,27,28 ]
  2. Evidence of benefit [ Time Frame: An expected average of 8 months ]
    clinical benefit rate (complete response (CR),partial response (PR),stable disease (SD) > 8 weeks),duration of response (DOR),time to progression (TTP), or tumor marker improvement, if appropriate

  3. Pharmacodynamic profile of Chiauranib [ Time Frame: On day 15,28 ]
    Plasma biomarkers: soluble vascular endothelial growth factor receptors (sVEGFR2), vascular endothelial growth factor (VEGF) Tumor tissue biomarkers: Aurora B, phospho-histone H3



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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;
  2. Patients with advanced solid tumors refractory to standard therapy or for which no standard therapy exists;
  3. Body mass index (BMI) is between 18 and 28;
  4. Age: 18~65 years;
  5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
  6. Laboratory criteria are as follows:

    1. 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
    2. 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
    3. Coagulation test: International Normalized Ratio (INR) < 1.5
  7. 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;
  8. Willingness to sign a written informed consent document

Exclusion Criteria:

  1. Life expectation < 3 months;
  2. 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;
  3. Have uncontrolled or significant cardiovascular disease, including:

    1. Myocardial infarction (< the last 12 months)
    2. Uncontrolled angina (< the last 6 months)
    3. Congestive heart failure (< the last 6 months), or Left Ventricular Ejection Fraction (LVEF) < 50% prior to study entry
    4. History of any significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, or TdP)
    5. History of significant QT interval prolongation, or Corrected QT Interval (QTc) > 450 ms prior to study entry
    6. History of cerebrovascular accident
    7. Symptomatic coronary heart disease requiring treatment with agents
    8. Uncontrolled hypertension (> 140/90 mmHg) by single agent;
  4. Have active bleeding , current thrombotic disease, or patients with bleeding potential receiving anticoagulation therapy;
  5. History of deep vein thrombosis or pulmonary embolism;
  6. Have unsolved toxicities (> grade 1) from prior anti-cancer therapy;
  7. 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;
  8. Have symptomatic brain metastasis;
  9. History of organ transplantation;
  10. Proteinuria positive;
  11. Congenital or acquired immunodeficiency, active infections;
  12. Any mental or cognitive disorder, that would impair the ability to understand the informed consent document or the operation and compliance of study;
  13. Any other condition which is inappropriate for the study in the opinion of the investigators.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02122809


Locations
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China, Beijing
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing, China, 100021
Sponsors and Collaborators
Chipscreen Biosciences, Ltd.
Investigators
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Principal Investigator: Yuankai Shi Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Chipscreen Biosciences, Ltd.
ClinicalTrials.gov Identifier: NCT02122809     History of Changes
Other Study ID Numbers: CAR101
First Posted: April 25, 2014    Key Record Dates
Last Update Posted: June 17, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Chipscreen Biosciences, Ltd.:
Chiauranib, advanced solid tumors, phase 1 study