Study of Apatinib in RET Fusion Positive Advanced Non-small Cell Lung Cancer

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

RET fusions are present in 1% to 2% of unselected population of non-small cell lung cancer (NSCLC). Existing US Food and Drug Administration-approved inhibitors of RET tyrosine kinase show promising therapeutic effects in a non-small cell lung cancer patients. Apatinib is an oral multi-kinase inhibitors including RET fusions. This study is designed to evaluate the safety and tolerability of Apatinib in patients with RET fusion positive advanced NSCLC.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tongji University
• Treatments: Apatinib

Criteria

Inclusion Criteria:

• Aged ≥18 and ≤80 years.

• ECOG performance status of 0 to 1.

• Life expectancy of more than 12 weeks.

• At least one measurable lesion exists.(RECIST 1.1)

• Histologically or cytologic confirmed RET fusion positive advanced Non-small cell lung cancer who failed to prior therapies.

• Required laboratory values including following parameters: ANC: ≥ 1.5 x 10^9/L, Platelet count: ≥ 80 x 10^9/L, Hemoglobin: ≥ 90 g/L, Total bilirubin: ≤ 1.5 x upper limit of normal, ULN, ALT and AST: ≤ 1.5 x ULN, BUN and creatine clearance rate: ≥ 50 mL/min LVEF: ≥ 50% QTcF: < 470 ms

• Signed informed consent

• Females of child-bearing potential must have negative serum pregnancy test. Sexually active male and those having childbearing potential must practice contraception during the study.

Exclusion Criteria:

• Squamous carcinoma (including adeno-squamous carcinoma), small cell lung cancer

• Subjects with third space fluid that can not be controled by drainage or other methods.

• Obvious cavity or necrosis formed in the tumor

• Uncontrolled hypertension

• Hymoptysis, more than 2.5ml daily

• Thrombosis in 12 months, including pulmonary thrombosis, stroke, or deep venous thrombosis

• Received big surgery, had bone fracture or ulcer in 4 weeks

• Urine protein >++, or urine protein in 24 hours> 1.0g

• pregnant or lactating woman

• Receiving any other antitumor therapy.

• Known history of hypersensitivity to apatinib or any of it components.