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

Hengrui Medicine

Status and phase: Completed; Phase 1

Conditions: Advanced Solid Tumor

Treatments: Drug: Famitinib Malate Capsule

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01762280

FMTN-I

Details and patient eligibility

About

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

Full description

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 .

Enrollment: 55 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

Famitinib Malate

Experimental group

Description:

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

Treatment:

Drug: Famitinib Malate Capsule