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

Phase 1
18 Years
65 Years
Open (Enrolling)
Advanced Solid Tumor

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Trial Information

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

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 .

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose(MTD)

Outcome Time Frame:

2 months

Safety Issue:


Principal Investigator

Jinwan Wang, M.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Institute and Hospital, Chinese Academy of Medical Sciences


China: Food and Drug Administration

Study ID:




Start Date:

June 2009

Completion Date:

Related Keywords:

  • Advanced Solid Tumor
  • Famitinib
  • Advanced Solid tumor
  • Phase I
  • Neoplasms