Solid TumorPhase 1NCT01806376
A Phase I Study of Subutinib Maleate Capsules on Toleration and Pharmacokinetics
A Phase 1 study testing Subutinib Maleate capsules in people with Solid Tumor, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
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. Experimental Design： A phase Ⅰ study of single-center 3. Test drug: Subutinib Maleate capsules 4. Sample size≥20 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Subutinib Maleate capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Mar 2013to Sep 2014
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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
- According to the investigator's judgment, there are concomitant diseases which will seriously do harm to the subject's safety or obstruct the subject to complete the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Cao j nin, doctor, 02164175590 ext. 8216, cao_junning@hotmail.com
About this study
- purpose: to explore the maximum tolerated dose, dose-limiting toxicity of oral Subutinib Maleate capsules and rational dosage regimen for phase Ⅱ study
- Experimental Design： A phase Ⅰ study of single-center
- Test drug: Subutinib Maleate capsules
- Sample size≥20
Read the detailed description
The primary objective of this study is to explore the maximum tolerated dose, dose-limiting toxicity of oral Subutinib Maleate capsules and rational dosage regimen for phase Ⅱ study, to investigate the pharmacokinetics of single and multiple oral doses of Subutinib Maleate capsules.
- Conditions
- Solid Tumor
- Being tested
- Subutinib Maleate capsules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subutinib Maleate capsulesDrug
Dose escalation will be dependent on any dose limiting toxicities
| Study group | Role | What they receive |
|---|---|---|
| Subutinib Maleate capsules | Experimental | Dose escalation will be dependent on any dose limiting toxicities Receives: Drug: Subutinib Maleate capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity， maximum tolerated dose.
Measured: 2 months
Secondary outcomes (2)
Pharmacokinetics
Subutinib Maleate pharmacokinetic parameters , include AUC, Cmax, Tmax, and t1/2
Measured: 2 months
Pharmacodynamics
The response of Subutinib Maleate on tumor.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionSep 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fudan University
- Responsible party
- Sponsor
- Investigators
- Li jin, doctor, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01806376
- Sponsor's protocol ID
- SBYN-Ⅰ-01
- Status last verified
- Mar 2013
- First submitted
- 1 Mar 2013
- Last updated
- 8 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes