A Phase I Study of Famitinib Malate in Patients With Soli... | NCT01762280

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

NCT01762280

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Status

Completed

Last Update Posted

Apr 18, 2018Actual

Enrollment

55Actual

Phase

Phase 1

Conditions

Advanced Solid Tumor

Interventions

Famitinib Malate Capsule

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009Actual

Primary Completion Date

Apr 2012Actual

Completion Date

Jul 2012Actual

First Submitted Date

Dec 26, 2012

First Submission Date that Met QC Criteria

Jan 4, 2013

First Posted Date

Jan 7, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2018

Last Update Posted Date

Apr 18, 2018Actual

Name	Class
Chinese Academy of Medical Sciences	OTHER
Chinese Academy of Sciences	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

To evaluate the safety and tolerability of Famitinib, and the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT).
To determine the pharmacokinetic profile of Famitinib and its metabolites .
To assess preliminary antitumor activity .
To determine preliminary dose and regimen for phase II study .

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

55Actual

Label	Type	Description	Intervention Names
Famitinib Malate	Experimental	Famitinib either at 4,8,13,20,27,36 mg, p.o. once daily	Drug: Famitinib Malate Capsule

Name	Type	Description	Arm Group Labels	Other Names
Famitinib Malate Capsule	Drug		Famitinib Malate

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetics	Famitinib pharmacokinetic parameters , include AUC, Cmax, Tmax, and t1/2	2 months
Objective response rate		2 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cancer Institute and Hospital Chinese Academy of Medical Sciences		Beijing			China