A Phase I Study of Subutinib Maleate Capsules on Toleration and Pharmacokinetics

NCT01806376 | Unknown Phase 1 DMC

• 1 other identifier: SBYN-Ⅰ-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.purpose: to explore the maximum tolerated dose, dose-limiting toxicity of oral Subutinib Maleate capsules and rational dosage regimen for phase Ⅱ study
2. 2.Experimental Design： A phase Ⅰ study of single-center
3. 3.Test drug: Subutinib Maleate capsules
4. 4.Sample size≥20

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Dose-limiting toxicity， maximum tolerated dose.

  2 months

Secondary Outcomes (2)

• Pharmacokinetics

  2 months

• Pharmacodynamics

  2 months

Study Arms (1)

Subutinib Maleate capsules

EXPERIMENTAL

Dose escalation will be dependent on any dose limiting toxicities

Drug: Subutinib Maleate capsules

Interventions

Subutinib Maleate capsules DRUG

Dose escalation will be dependent on any dose limiting toxicities

Subutinib Maleate capsules

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who have histologically or cytologically confirmed solid tumors
• Subjects who have failed standard effective therapy or have a diagnosis for which no standard effective treatment is available;
• Aged 18 to 70 years old; Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2; Life expectancy greater than 3 months;
• If the subject has been given other chemotherapy drugs, it's necessary to discontinue them more than 4 weeks. If the chemotherapy drugs are Nitrosoureas and Mitomycin C, it's necessary to discontinue them more than 6 weeks. If the subject has accepted major surgery, it's necessary to wait more than 4 weeks before the subject participating in this study.
• Blood test: Hb≥100g/L(no blood transfusion within 14 days); ANC≥1.5×109/L, PLT≥100×109/L
• Biochemistry: TBIL and ALT and AST and Cr are in normal range, or creatinine clearance ≥60ml/min; Triglyceride≤3.0mmol/L; Cholesterol ≤7.75mmol/L.
• Doppler ultrasound measurement: LVEF ≥ LLN
• Female subjects should agree to take contraceptives during the study and within 6 months after the study (such as intrauterine device \[IUD\], contraceptive drugs or condoms); within 7 days before they enter the study, their serum or human chorionic gonadotropin should be negative, and must be in the non-lactation period; male subjects should agree to take contraceptives during the study and within 6 months after the study.
• The subject is willing to participate in this study, and he/she has signed the Informed Consent Form, with good compliance.

You may not qualify if:

• The subject has participated in other drug clinical research in the past 4 weeks.
• The subject is accompanied with several factors which will influence the investigational drug administration orally, such as inability to swallow or after gastrointestinal resection or chronic diarrhea or intestinal obstruction.
• Central nervous system metastasis definitely.
• The subject is suffering from hypertension or myocardial ischemia or myocardial infarction or arrhythmia (including QT interval≥440ms) or Grade I heart failure.
• If the subject's systolic BP is over 140mmhg, with diastolic BP over 90mmhg, or the subject's blood pressure is well-controlled, he/she is not permitted to enroll in this study as well.
• The subject's urinalysis displays that urinary protein ≥ ++ , combined with 24-hour urinary protein \> 1.0g.
• The subject's is suffering from wounds or fractures which can not be cured for long time.
• Abnormal coagulation: The subject has bleeding tendency such as active peptic ulcer or the subject is receiving thrombolytic or anticoagulant therapy.
• There are pre-dosing arterial/venous thrombotic events on this subject, such as cerebrovascular accident (including TIA) or deep vein thrombosis or pulmonary embolism.
• The subject is accepting anticoagulants or vitamin K antagonists such as warfarin or heparin or analogue therapy; If the subject's INR ≤ 1.5, he/she is allowed to use small doses of warfarin (1mg oral q d) or small doses of aspirin(less than 100mg each day), and the purpose of the treatment should be prevention.
• Abnormal thyroid function.
• There is history of mental drug abuse occurred in the subject, or the subject is suffering from mental disorders.
• There is history of immunodeficiency occurred in the subject, including HIV positive or other acquired or congenital immunodeficiency diseases, or the subject has accepted organ transplant before.
• Lung squamous cell carcinoma.
• The subject has received small molecule targeted drug therapy of inhibition of VEGFR-2 and PDGFRβ

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead
• Fudan University: collaborator

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Study Officials

• Li jin, doctor

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 1, 2013
• First Posted: March 7, 2013
• Study Start: March 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: March 8, 2013

Record last verified: 2013-03

Locations

CN (1)