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

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

Study Overview

• Status: Completed
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: Famitinib Malate Capsule

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 Type: Interventional
• Enrollment (Actual): 55
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Cancer Institute and Hospital Chinese Academy of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Famitinib Malate; Famitinib either at 4,8,13,20,27,36 mg, p.o. once daily	Drug: Famitinib Malate Capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum tolerated dose(MTD)	2 months
Dose-limiting toxicity(DLT)	2 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Collaborators: Cancer Institute and Hospital, Chinese Academy of Medical Sciences; Chinese Academy of Sciences
• Investigators: Principal Investigator: Jinwan Wang, M.D, Cancer Institute and Hospital, Chinese Academy of Medical Sciences; Principal Investigator: Dafang Zhong, Ph.D, Chinese Academy of Science Shanghai Institution of Materia Medica

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2009
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: December 26, 2012
• First Submitted That Met QC Criteria: January 4, 2013
• First Posted (Estimate): January 7, 2013

Study Record Updates

• Last Update Posted (Actual): April 18, 2018
• Last Update Submitted That Met QC Criteria: April 16, 2018
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Phase I; Famitinib; Advanced Solid tumor
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: FMTN-I