Trial | NCT01762280  Report issue

Official Title

A Phase I Study of Famitinib Malate in Patients With Solid Tumor

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    famitinib ...

  • Study Participants

    55
Famitinib is a novel oral multitargeted tyrosine kinase inhibitor with antitumor and antiangiogenic activities. This study is designed to evaluate the safety and tolerability of Famitinib in patients with solid tumor
To evaluate the safety and tolerability of Famitinib, and the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT).
To determine the pharmacokinetic profile of Famitinib and its metabolites .
To assess preliminary antitumor activity .
To determine preliminary dose and regimen for phase II study .
Study Started
Jun 30
2009
Primary Completion
Apr 30
2012
Study Completion
Jul 31
2012
Last Update
Apr 18
2018

Drug Famitinib Malate Capsule

Famitinib Malate Experimental

Famitinib either at 4,8,13,20,27,36 mg, p.o. once daily

Criteria 

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
No Results Posted