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Phase I Study of Concurrent Chemoradiotherapy With Famitinib for Patients With Locally Advanced Nasopharyngeal Carcinoma


Phase 1
18 Years
65 Years
Open (Enrolling)
Both
Locally Advanced Nasopharyngeal Carcinoma

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Trial Information

Phase I Study of Concurrent Chemoradiotherapy With Famitinib for Patients With Locally Advanced Nasopharyngeal Carcinoma


Inclusion Criteria:



- 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.

Exclusion Criteria:

- 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

- 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Dose-limiting toxicity (DLT) and maximum tolerated dose (MTD)

Outcome Description:

To evaluate the DLT and MTD in patients with Concurrent Chemoradiotherapy With Famitinib

Outcome Time Frame:

3 weeks

Safety Issue:

Yes

Authority:

China: Food and Drug Administration

Study ID:

FMTN-I-LNPC

NCT ID:

NCT01462474

Start Date:

October 2011

Completion Date:

Related Keywords:

  • Locally Advanced Nasopharyngeal Carcinoma
  • Concurrent Chemoradiotherapy
  • Carcinoma
  • Nasopharyngeal Neoplasms

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