A Phase I Study of Famitinib Malate in Patients With Solid Tumor
18 Years
65 Years
Both
Advanced Solid Tumor
Trial Information
A Phase I Study of Famitinib Malate in Patients With Solid Tumor
1. To evaluate the safety and tolerability of Famitinib, and the maximum tolerated dose
(MTD) and dose-limiting toxicity (DLT).
2. To determine the pharmacokinetic profile of Famitinib and its metabolites .
3. To assess preliminary antitumor activity .
4. To determine preliminary dose and regimen for phase II study .
Inclusion Criteria:
- Histological confirmed advanced or metastatic solid tumor，at least one measurable
lesion, larger than 10 mm in diameter by spiral CT scan(scanning layer ≤ 5 mm )
- no standard therapy protocol available according to patients'condition
- both sex, age 18 to 65
- ECOG 0-1
- Life expectancy more than 3 months
- ALT,AST,TB≤1.5(UNL),normal serum creatinine level, normal electrolyte or can be
corrected by medication
- Subjects receiving damage caused by other therapeutic has been restored, the interval
more than six weeks since the last receiving nitroso or mitomycin; more than 4 weeks
since last receiving radiotherapy, other cytotoxic drugs or surgery
- Understand and agree to sign informed consent form.
Exclusion Criteria:
- Peripheral neuropathy ≥ Grade 2(according to NCI-CTC 3.0)
- Preexisting uncontrolled hypertension defined as more than 140/90 mmHg by using
single agent therapy, ＞Grade 1 (NCI-CTCAE 3.0 ) myocardial ischemia,
arrhythmia,cardiac function insufficiency
- PT, APTT, TT, Fbg abnormal(PT>16s,APTT>43s,TT>21s,Fbg<2g/L), or have hemorrhagic
tendency or receiving the therapy of thrombolysis or anticoagulation
- Active peptic ulcer
- Previously medication include sunitinib
- More than 4 weeks since the last clinical trial
- Pregnant or lactating women
- Women of childbearing age do not take effective contraceptive measures
- Allergies, or known allergy history to components of the drug
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maximum tolerated dose(MTD)
Outcome Time Frame:
2 months
Safety Issue:
Yes
Principal Investigator
Jinwan Wang, M.D
Investigator Role:
Principal Investigator
Investigator Affiliation:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Authority:
China: Food and Drug Administration
Study ID:
FMTN-I
NCT ID:
NCT01762280
Start Date:
June 2009
Completion Date:
Related Keywords:
- Advanced Solid Tumor
- Famitinib
- Advanced Solid tumor
- Phase I
- Neoplasms
Name | Location |
|---|
