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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01762280

Enrollment

Registered

2013-01-07

Start date

2009-06-30

Completion date

2012-07-31

Last updated

2018-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Tumor

Keywords

Famitinib, Advanced Solid tumor, Phase I

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 .

Interventions

DRUGFamitinib Malate Capsule

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026