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

Phase 1

Completed

• Conditions: Advanced Solid Tumor
• Interventions: Drug: Famitinib Malate Capsule

• Registration Number: NCT01762280
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

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

Detailed 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 .

Study Timeline

• Study Start: 2009-06
• Primary Completion: 2012-04
• Study Completion: 2012-07
• Study First Submitted: 2012-12-26
• Status Verified: 2013-01
• Study First Submitted QC: 2013-01-04
• Study First Posted: 2013-01-07
• Last Update Submitted: 2018-04-16
• Last Update Posted: 2018-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Famitinib Malate	Famitinib Malate Capsule	Famitinib either at 4,8,13,20,27,36 mg, p.o. once daily

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose(MTD)	2 months
Dose-limiting toxicity(DLT)	2 months

Secondary Outcome Measures

Name	Time	Method
Number of volunteers with adverse events	2 months
Objective response rate	2 months
Pharmacokinetics	2 months	Famitinib pharmacokinetic parameters , include AUC, Cmax, Tmax, and t1/2
Pharmacodynamics	2 months	The response of Famitinib on tumor.

Trial Locations

Locations (1)

Cancer Institute and Hospital Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China