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

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2012-07-31

Brief Summary

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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

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Detailed Description

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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 .

Conditions

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Advanced Solid Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Famitinib Malate

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

Group Type EXPERIMENTAL

Famitinib Malate Capsule

Intervention Type DRUG

Interventions

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Famitinib Malate Capsule

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes