A Trial of C-met Kinase Inhibitor HS-10241 in Subjects With Advanced Solid Tumours
NCT ID: NCT02977364
Last Updated: 2016-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
50 participants
INTERVENTIONAL
2016-11-30
2021-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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HS-10241 100mg
HS-10241 100mg daily
HS-10241
HS-10241 200mg
HS-10241 200mg daily
HS-10241
HS-10241 400mg
HS-10241 400mg daily
HS-10241
HS-10241 600mg
HS-10241 600mg daily
HS-10241
HS-10241 800mg
HS-10241 800mg daily
HS-10241
HS-10241 1000mg
HS-10241 1000mg daily
HS-10241
Interventions
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HS-10241
Eligibility Criteria
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Inclusion Criteria
2. c-MET positive patients preferred in dose escalation phase; c-MET of patients must fulfill ICH++\~+++ or FISH≥4 times in dose expansion phase.
3. Confirmed that there are at least 1 can be measured in accordance with the standard RECIST1.1 by CT or MRI.
4. 18 \~65 years of age.
5. ECOG performance status of 0\~1.
6. Life expectancy of at least 3 months.
7. Recovered from toxicities of prior anti-cancer treatment to Grade 1 or less (except alopecia).
8. Acceptable hematologic status (without hematologic supports including hematopoietic factor, blood transfusion) defined below:
* Absolute neutrophil count (ANC) ≥ 1500/μL
* Platelet count ≥ 100000/μL
* Hemoglobin ≥ 9.0 g/dL
9. Acceptable liver function defined below:
* Total bilirubin ≤ 2 times upper limit of normal range (ULN)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 times ULN; however, ≤ 5 times ULN in a subject who has liver metastases
10. Acceptable renal function defined below:
* Serum creatinine ≤ 1.5 times ULN or calculated creatinine clearance (by the Cockcroft-Gault formula) ≥ 60 mL/minutes
11. Acceptable coagulation status defined below:
* Prothrombin time \< 1.5 times ULN
* Partial thrombin time \< 1.5 times UL
12. HIV Ag/Ab(-).
13. HCV Ab(-);or HCV Ab(+) but HCV RNA(-).
14. HBsAg（-）and HBcAb（-）in dose escalation phase；HBV DNA\<1×103copies/ml if HBsAg（+）or HBcAb（+）in dose expansion phase.
15. Ability to understand the purposes and risks of the trial and his/her informed consent using the human research ethics committee (HREC) approved informed consent form was obtained before the entering the trial.
Exclusion Criteria
2. Anti-cancer treatment with radiation therapy（not including non target lesions receiving palliative radiotherapy）, chemotherapy,hormonotherapy or surgery（small surgery, including the implantation of external equipment or fine needle aspiration, at least 7 days; diagnostic or palliative surgery, at least 14 days） within 4 weeks (6 weeks for nitrosoureas or Mitomycin C)prior to trial entry.
3. Medical history of difficulty swallowing, malabsorption or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested product
4. Cardiac disease with New York Heart Association (NYHA) Class III or IV, including congestive heart failure, myocardial infarction within 6 months prior to the trial entry, unstable arrhythmia, or symptomatic peripheral arterial vascular disease.
5. Symptomatic brain metastases or unstable brain metastases (notes: Patients with asymptomatic brain metastases previously treated for the study, but must be kept stable for at least 4 weeks and receive a stable dose of the drug)
6. Obvious neurological and mental disorder.
7. Other previous or concomitant tumors (except for the effective treatment of melanoma, cervical carcinoma in situ, ductal carcinoma in situ or malignant tumor after effective treatment, remission 3 years and considered to have been cured).
8. Active, uncontrolled bacterial, fungal infections, requiring systemic therapy.
9. Recent venous thrombosis (including deep vein thrombosis or pulmonary embolism within 0.5 year of trial entry)
10. History of organ allograft, autologous stem cell transplantation, or allogeneic stem cell transplantation.
11. Participation in an investigational drug or device trial within 4 weeks prior to the trial entry.
12. Anti-cancer treatment with radiation therapy, chemotherapy or immunotherapy within 4 weeks (6 weeks for nitrosoureas or Mitomycin C) prior to trial entry.
13. Major surgery, other than diagnostic surgery, within 4 weeks prior to the trial entry, without complete recovery
14. Taking a medication that is a moderate or strong inhibitor or inducer of CYP2C9; taking a medication that prolongs QT interval and has a risk of Torsades de Pointes .
15. Pregnant (positive serum beta human chorionic gonadotropin \[β-HCG\] test at Screening) or is currently breast-feeding, their partner anticipates becoming pregnant/impregnating during the trial or within 6 months after receiving the last dose of trial treatment.
16. Known drug abuse or alcohol abuse.
17. Concomitant disease or condition that could interfere with the conduct of the trial, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this trial.
18 Years
65 Years
ALL
No
Sponsors
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Jiangsu Hansoh Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Yuankai Shi, MD
Role: primary
Other Identifiers
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HS-10241-101
Identifier Type: -
Identifier Source: org_study_id