Locally Advanced Nasopharyngeal CarcinomaPhase 1FMTN-I-LNPCNCT01462474
Concurrent Chemoradiotherapy With Famitinib for Patients With Locally Advanced Nasopharyngeal Carcinoma
A Phase 1 study testing Famitinib, Cisplatin and radiation（IMRT） in people with Locally Advanced Nasopharyngeal Carcinoma, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
RATIONALE: Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and Flt3. Phase I study of mono famitinib has shown that the drug's toxicity is manageable. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Locally Advanced Nasopharyngeal Carcinoma
- What is being tested?
- Famitinib, Cisplatin and radiation（IMRT）
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Oct 2011to Jan 2016
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed nasopharyngeal differentiation or undifferentiation carcinoma, WHO II or III
- Newly diagnosed T3-4N1（exception metastatic uni or bil retropharyngeal lymph nodes N1） or any TN2-3(7th UICC/AJCC) locally advanced nasopharyngeal carcinoma
- 18-65 years of age
- ECOG performance status of 0 or 1
- Life expectancy of more than 6 months
- At least one measurable lesion :MRI scan larger than 10 mm in diameter, malignant lymph nodes larger than 10 mm in short axis
- Female: All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 6 months after the last dose of test article. Child bearing potential, a negative urine or serum pregnancy test result before initiating Famitinib. Male: All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 6 months after the last dose of test article.
- Signed and dated informed consent. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.
Who cannot join
- Before or at the same time any second malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- Any factors that influence the usage of oral administration
- Known Spinal Cord compression or diseases of brain or pia mater by CT /MRI Screening
- Imageology shows that tumor lesion less than 5 mm to great vessels(internal carotid and jugular vein)
- Hemoglobin < 90g/L, platelets < 100×10^9/L, neutrophils < 2×10^9/L, total bilirubin ≥ 1.25×the upper limit of normal(ULN), ALT\AST ≥ 1.5x ULN), serum creatine > 1x ULN, creatinine clearance rate < 60ml/min, Cholesterol > 7.75 mmol/L and triglyceride > 3 mmol/L, LVEF: < LLN
- Hypertensive( more than 140/90 mmHg ), more than class I (NCI CTCAE 3.0 ) myocardial ischemia, arrhythmia(including QTcF:male ≥ 450 ms, female ≥470 ms), or cardiac insufficiency
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- URT: urine protein ≥ ++ and > 1.0 g of 24 h
- Long-term untreated wounds or fractures
- PT, APTT, TT, Fbg abnormal, having hemorrhagic tendency (eg. active peptic ulcer disease) or receiving the therapy of thrombolysis or anticoagulation
- Before the first treatment occurs artery / venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism, etc
- Preexisting thyroid dysfunction, even using medical therapy, thyroid function cannot maintain in the normal range
- Abuse of Psychiatric drugs or dysphrenia
- Subject of Viral hepatitis type B or type C
- Subject of immunodeficiency: HIV positive, or other acquired immunodeficiency, congenital immunodeficiency, or organ transplantation
- With drug CYP3A4 inhibitor, inducer, or substrate
- Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Medical Oncology, Cancer Center, Sun Yet-sen University
Guangzhou, Guangdong
About this study
Official title: Phase I Study of Concurrent Chemoradiotherapy With Famitinib for Patients With Locally Advanced Nasopharyngeal Carcinoma
RATIONALE: Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and Flt3. Phase I study of mono famitinib has shown that the drug's toxicity is manageable.
PURPOSE: This phase I trial is studying the safety and tolerance of concurrent chemoradiotherapy with famitinib for patients with locally advanced nasopharyngeal carcinoma.
- Being tested
- Famitinib, Cisplatin, radiation（IMRT）
- Keywords
- Concurrent Chemoradiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FamitinibDrug
Either at 12.5 mg, 16.5 mg、20 mg or 25 mg qd p.o., 2 weeks before concurrent chemoradiotherapy and D1-D49, exception D1, D22, and D43.
CisplatinDrug
100 mg/m2, D1, D22, and D43(q3w)
radiation（IMRT）Radiation
IMRT (Intensity-Modulated Radiation Therapy). Radiation is delivered to GTV at 70 Gy in 32-33 fractions, CTV1 at 60 Gy in 32-33 fractions and CTV2 at 54 Gy in 32-33 fractions
| Study group | Role | What they receive |
|---|---|---|
| Drug: Famitinib | Experimental | Not described Receives: Drug: Famitinib; Drug: Cisplatin; Radiation: radiation（IMRT） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT) and maximum tolerated dose (MTD)
To evaluate the DLT and MTD in patients with Concurrent Chemoradiotherapy With Famitinib
Measured: 3 weeks
Secondary outcomes (8)
ORR (Objective Response Rate)
Measured: 12 weeks after treatment
OS(Overall Survival)
Measured: 2 years and 3 years
DFMR(Distant Free Metastases Rate)
Measured: 2 years and 3 years
DFSR(Disease Free Survival Rate)
Measured: 2 years and 3 years
LFRSR(Local Free Recurrence Survival Rate)
Measured: 2 years and 3 years
Quantitative evaluation of the blood perfusion of the metastatic cervical lymph nodes by dynamic contrast-enhanced ultrasonography after a loading dose of famitinib for 14 days
Measured: 2 weeks
To identify the tumor's molecular profiles in patients with NPCs
Measured: 2 years
To measure the changes of serum c-Kit，VEGF，Filt，KDR，and PDGFR
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionAug 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Nasopharyngeal CarcinomaStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sun Yat-sen University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01462474
- Sponsor's protocol ID
- FMTN-I-LNPC
- Acronym
- FMTN-I-LNPC
- Status last verified
- Nov 2011
- First submitted
- 27 Oct 2011
- 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
- Phase I Study of Concurrent Chemoradiotherapy With Famitinib for Patients With Locally Advanced Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT01462474
- Acronym / sponsor ID
- FMTN-I-LNPC / FMTN-I-LNPC
- Keywords
- Concurrent Chemoradiotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Sun Yat-sen University
- Study start
- Oct 2011
- Primary completion
- Aug 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 31 Oct 2011 (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.
RATIONALE: Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and Flt3. Phase I study of mono famitinib has shown that the drug's toxicity is manageable.
PURPOSE: This phase I trial is studying the safety and tolerance of concurrent chemoradiotherapy with famitinib for patients with locally advanced nasopharyngeal carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Drug: Famitinib | Experimental | Drug: Famitinib, Drug: Cisplatin, Radiation: radiation（IMRT） |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed nasopharyngeal differentiation or undifferentiation carcinoma, WHO II or III
- Newly diagnosed T3-4N1（exception metastatic uni or bil retropharyngeal lymph nodes N1） or any TN2-3(7th UICC/AJCC) locally advanced nasopharyngeal carcinoma
- 18-65 years of age
- ECOG performance status of 0 or 1
- Life expectancy of more than 6 months
Key exclusion criteria (16 listed)
- Before or at the same time any second malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- Any factors that influence the usage of oral administration
- Known Spinal Cord compression or diseases of brain or pia mater by CT /MRI Screening
- Imageology shows that tumor lesion less than 5 mm to great vessels(internal carotid and jugular vein)
- Hemoglobin < 90g/L, platelets < 100×10^9/L, neutrophils < 2×10^9/L, total bilirubin ≥ 1.25×the upper limit of normal(ULN), ALT\AST ≥ 1.5x ULN), serum creatine > 1x ULN, creatinine clearance rate < 60ml/min, Cholesterol > 7.75 mmol/L and triglyceride > 3 mmol/L, LVEF: < LLN
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 |
|---|---|---|
| FamitinibEither at 12.5 mg, 16.5 mg、20 mg or 25 mg qd p.o., 2 weeks before concurrent chemoradiotherapy and D1-D49, exception D1, D22, and D43. | Drug | Drug: Famitinib |
| Cisplatin100 mg/m2, D1, D22, and D43(q3w) | Drug | Drug: Famitinib |
| radiation（IMRT）IMRT (Intensity-Modulated Radiation Therapy). Radiation is delivered to GTV at 70 Gy in 32-33 fractions, CTV1 at 60 Gy in 32-33 fractions and CTV2 at 54 Gy in 32-33 fractions | Radiation | Drug: Famitinib |
Primary outcome
Dose-limiting toxicity (DLT) and maximum tolerated dose (MTD)
Time frame: 3 weeks
To evaluate the DLT and MTD in patients with Concurrent Chemoradiotherapy With Famitinib
8 secondary outcomes
ORR (Objective Response Rate)
Time frame: 12 weeks after treatment
OS(Overall Survival)
Time frame: 2 years and 3 years
DFMR(Distant Free Metastases Rate)
Time frame: 2 years and 3 years
DFSR(Disease Free Survival Rate)
Time frame: 2 years and 3 years
LFRSR(Local Free Recurrence Survival Rate)
Time frame: 2 years and 3 years
Quantitative evaluation of the blood perfusion of the metastatic cervical lymph nodes by dynamic contrast-enhanced ultrasonography after a loading dose of famitinib for 14 days
Time frame: 2 weeks
To identify the tumor's molecular profiles in patients with NPCs
Time frame: 2 years
To measure the changes of serum c-Kit，VEGF，Filt，KDR，and PDGFR
Time frame: 2 years
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.
The record lists no contact. Use the official record to reach the sponsor.
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, Cisplatin and radiation（IMRT） in people with Locally Advanced Nasopharyngeal Carcinoma, 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 16 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?
Dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) (time frame: 3 weeks). 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.