Clinical trial NCT01762280: A Phase I Study of Famitinib Malate in Patients With Solid Tumor
Official title: A Phase I Study of Famitinib Malate in Patients With Solid Tumor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumor
Keywords: Famitinib
Advanced Solid tumor
Phase I
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Chinese Academy of Medical Sciences
name: Chinese Academy of Sciences
First posted: 2013-01-07
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 .

Eligibility criteria: 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

Primary outcomes:
measure: Maximum tolerated dose(MTD)
timeFrame: 2 months
measure: Dose-limiting toxicity(DLT)
timeFrame: 2 months
Secondary outcomes:
measure: Pharmacokinetics
timeFrame: 2 months
measure: Objective response rate
timeFrame: 2 months
measure: Number of volunteers with adverse events
timeFrame: 2 months
measure: Pharmacodynamics
timeFrame: 2 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Institute and Hospital Chinese Academy of Medical Sciences
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Jinwan Wang, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Chinese Academy of Science Shanghai Institution of Materia Medica
name: Dafang Zhong, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: