NCT02540824

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2 nonsmall-cell-lung-cancer

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 4, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

September 4, 2015

Status Verified

September 1, 2015

Enrollment Period

1.9 years

First QC Date

August 29, 2015

Last Update Submit

September 3, 2015

Conditions

Non-small Cell Lung Cancer

Keywords

ApatinibRETgene fusionNon-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate (ORR)

    To evaluate ORR every 6-8 weeks after initiation of apatinib

    change from baseline in tumor size every 6-8 weeks after the initiation of apatinib, up to 24 months

Secondary Outcomes (4)

  • Progression Free Survival (PFS)

    24 months

  • overall survival (OS)

    24 months

  • Safety and Tolerability as measured by adverse events

    24 months

  • quality of life (QOL, measured by questionnaire)

    24 months

Study Arms (1)

Apatinib single agent arm

EXPERIMENTAL

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

Drug: Apatinib single agent arm

Interventions

Apatinib single agent armDRUG

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

Also known as: YN968D1
Apatinib single agent arm

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Oncology, Shanghai pulmonary hospital

Shanghai, 200433, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

apatinib

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Caicun Zhou, MD,PhD

    Shanghai Pulmonary Hospital, Tongji University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Caicun Zhou, MD,PhD

CONTACT

86-65115006-3050caicunzhoudr@126.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 29, 2015

First Posted

September 4, 2015

Study Start

January 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2017

Last Updated

September 4, 2015

Record last verified: 2015-09

Locations

CN(1)