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

NCT ID: NCT02540824

Last Updated: 2015-09-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2017-12-31

Brief 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.

Detailed Description

To observe objective response rate (ORR) of apatinib in RET fusion positive pre-treated advanced NSCLC.

To observe Progression free survival （PFS）. To assess the overall survival (OS). To assess safety and tolerability. To evaluate quality of life. To explore the relationship between biomarkers and the toxicity/efficacy of apatinib.

Conditions

Non-small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Apatinib single agent arm

Apatinib, single agent, 750mg once daily p.o until disease progression

Group Type: EXPERIMENTAL

Apatinib single agent arm

Intervention Type: DRUG

For RET-fusion positive advanced NSCLC patients who failed to previous treatment,treat with apatinib, single agent, 750mg once daily, p.o until disease progression

Interventions

Apatinib single agent arm

For RET-fusion positive advanced NSCLC patients who failed to previous treatment,treat with apatinib, single agent, 750mg once daily, p.o until disease progression

Intervention Type: DRUG

Other Intervention Names

YN968D1

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tongji University

OTHER

Sponsor Role: lead

Responsible Party

Caicun Zhou

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Caicun Zhou, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Pulmonary Hospital, Tongji University

Locations

Department of Oncology, Shanghai pulmonary hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Caicun Zhou, MD,PhD

Role: CONTACT

caicunzhoudr@126.com

86-65115006-3050

Facility Contacts

Caicun zhou, MD, PhD

Role: primary

caicunzhoudr@126.com

86-65115006-3050

shengxiang Ren, MD,PhD

Role: backup

harry_ren@126.com

Other Identifiers

FK-1407

Identifier Type: -

Identifier Source: org_study_id