Advanced Solid TumorPhase 1NCT01762280
A Phase I Study of Famitinib Malate in Patients With Solid Tumor
A Phase 1 study testing Famitinib Malate Capsule in people with Advanced Solid Tumor, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- Famitinib Malate Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteChina
- Study dates
- Jun 2009to Jul 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Pregnant or lactating women
- Women of childbearing age do not take effective contraceptive measures
- Allergies, or known allergy history to components of the drug
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Institute and Hospital Chinese Academy of Medical Sciences
Beijing
About this study
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
Read the 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 .
- Conditions
- Advanced Solid Tumor
- Being tested
- Famitinib Malate Capsule
- Keywords
- Famitinib, Advanced Solid tumor, Phase I
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Famitinib Malate CapsuleDrug
| Study group | Role | What they receive |
|---|---|---|
| Famitinib Malate | Experimental | Famitinib either at 4,8,13,20,27,36 mg, p.o. once daily Receives: Drug: Famitinib Malate Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose(MTD)
Measured: 2 months
Dose-limiting toxicity(DLT)
Measured: 2 months
Secondary outcomes (4)
Pharmacokinetics
Famitinib pharmacokinetic parameters , include AUC, Cmax, Tmax, and t1/2
Measured: 2 months
Objective response rate
Measured: 2 months
Number of volunteers with adverse events
Measured: 2 months
Pharmacodynamics
The response of Famitinib on tumor.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2013 (estimated)
- Study startJun 2009
- Primary completionApr 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chinese Academy of Medical Sciences, Chinese Academy of Sciences
- Responsible party
- Sponsor
- Investigators
- Jinwan Wang, M.D, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical SciencesDafang Zhong, Ph.D, Principal investigator, Chinese Academy of Science Shanghai Institution of Materia Medica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01762280
- Sponsor's protocol ID
- FMTN-I
- Status last verified
- Jan 2013
- First submitted
- 26 Dec 2012
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Famitinib Malate in Patients With Solid Tumor
- ClinicalTrials.gov ID
- NCT01762280
- Acronym / sponsor ID
- FMTN-I
- Conditions
- Advanced Solid Tumor
- Keywords
- Famitinib, Advanced Solid tumor, Phase I
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Chinese Academy of Medical Sciences, Chinese Academy of Sciences
- Study start
- Jun 2009 (actual)
- Primary completion
- Apr 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 7 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Famitinib Malate | Experimental | Drug: Famitinib Malate CapsuleFamitinib either at 4,8,13,20,27,36 mg, p.o. once daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Famitinib Malate Capsule | Drug | Famitinib Malate |
Primary outcome
Maximum tolerated dose(MTD)
Time frame: 2 months
Dose-limiting toxicity(DLT)
Time frame: 2 months
4 secondary outcomes
Pharmacokinetics
Time frame: 2 months
Objective response rate
Time frame: 2 months
Number of volunteers with adverse events
Time frame: 2 months
Pharmacodynamics
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jinwan Wang, M.D principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Dafang Zhong, Ph.D principal investigator
Chinese Academy of Science Shanghai Institution of Materia Medica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Famitinib Malate Capsule in people with Advanced Solid Tumor, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose(MTD) (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2018.