Clinical trial · Interventional
A Phase I Study of Famitinib Malate in Patients With Solid Tumor
NCT01762280CI-TRIAL-00032578completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Famitinib Malate Capsule | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Famitinib Malate
- description
- Famitinib either at 4,8,13,20,27,36 mg, p.o. once daily
- interventionNames
- Drug: Famitinib Malate Capsule
Primary outcomes (2)
- measure
- Maximum tolerated dose(MTD)
- timeFrame
- 2 months
- measure
- Dose-limiting toxicity(DLT)
- timeFrame
- 2 months
Secondary outcomes (4)
- measure
- Pharmacokinetics
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.