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

Advanced Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01762280
• Other study ID #: FMTN-I
• Status: Completed
• Phase: Phase 1
• First received: December 26, 2012
• Last updated: April 16, 2018
• Start date: June 2009
• Est. completion date: July 2012

Study information

• Verified date: January 2013
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: July 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumor

Intervention

Drug:
• Famitinib Malate Capsule

Locations

Country	Name	City	State
China	Cancer Institute and Hospital Chinese Academy of Medical Sciences	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.	Chinese Academy of Medical Sciences, Chinese Academy of Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose(MTD)		2 months
Primary	Dose-limiting toxicity(DLT)		2 months
Secondary	Pharmacokinetics	Famitinib pharmacokinetic parameters , include AUC, Cmax, Tmax, and t1/2	2 months
Secondary	Objective response rate		2 months
Secondary	Number of volunteers with adverse events		2 months
Secondary	Pharmacodynamics	The response of Famitinib on tumor.	2 months