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

NCT01762280 | Completed Phase 1 DMC

• 1 other identifier: FMTN-I
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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

Conditions

Advanced Solid Tumor

Keywords

Famitinib; Advanced Solid tumor; Phase I

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose(MTD)

  2 months

• Dose-limiting toxicity(DLT)

  2 months

Secondary Outcomes (4)

• Pharmacokinetics

  2 months

• Objective response rate

  2 months

• Number of volunteers with adverse events

  2 months

• Pharmacodynamics

  2 months

Study Arms (1)

Famitinib Malate

EXPERIMENTAL

Famitinib either at 4,8,13,20,27,36 mg, p.o. once daily

Drug: Famitinib Malate Capsule

Interventions

Famitinib Malate Capsule DRUG

Famitinib Malate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead
• Chinese Academy of Medical Sciences: collaborator
• Chinese Academy of Sciences: collaborator

Study Sites (1)

Cancer Institute and Hospital Chinese Academy of Medical Sciences

Beijing, China

Location

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2012
• First Posted: January 7, 2013
• Study Start: June 1, 2009
• Primary Completion: April 1, 2012
• Study Completion: July 1, 2012
• Last Updated: April 18, 2018

Record last verified: 2013-01

Locations

CN (1)