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

Primary Purpose

Non-small Cell Lung Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Apatinib single agent arm

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Apatinib, RET, gene fusion, Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Department of Oncology, Shanghai pulmonary hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Apatinib single agent arm

Arm Description

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

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR)

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

Secondary Outcome Measures

Progression Free Survival (PFS)

PFS is evaluated in 24 months since the treatment began

overall survival (OS)

evaluated in the 24th month since the treatment began

Safety and Tolerability as measured by adverse events

Number of Participants with treatment related Adverse Events as Assessed by CTCAE v4.0

quality of life (QOL, measured by questionnaire)

Change from baseline in Pain on the 11 point short pain scale (SPS-11)

Full Information

NCT ID

NCT02540824

First Posted

August 29, 2015

Last Updated

September 3, 2015

Sponsor

Tongji University

1. Study Identification

Unique Protocol Identification Number

NCT02540824

Brief Title

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

Official Title

A Phase II Clinical Trial to Investigate Efficacy and Safety of Apatinib as a Single Agent in RET-fusion Gene Positive Non-small Cell Lung Cancer Who Failed to Previous Treatment.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Unknown status

Study Start Date

January 2015 (undefined)

Primary Completion Date

December 2016 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tongji University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-small Cell Lung Cancer

Keywords

Apatinib, RET, gene fusion, Non-small Cell Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Apatinib single agent arm

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Apatinib single agent arm

Other Intervention Name(s)

YN968D1

Intervention Description

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

Primary Outcome Measure Information:

Title

Objective Response Rate (ORR)

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Progression Free Survival (PFS)

Description

PFS is evaluated in 24 months since the treatment began

Time Frame

24 months

Title

overall survival (OS)

Description

evaluated in the 24th month since the treatment began

Time Frame

24 months

Title

Safety and Tolerability as measured by adverse events

Description

Number of Participants with treatment related Adverse Events as Assessed by CTCAE v4.0

Time Frame

24 months

Title

quality of life (QOL, measured by questionnaire)

Description

Change from baseline in Pain on the 11 point short pain scale (SPS-11)

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Caicun Zhou, MD,PhD

Phone

86-65115006-3050

caicunzhoudr@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Caicun Zhou, MD,PhD

Organizational Affiliation

Shanghai Pulmonary Hospital, Tongji University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Oncology, Shanghai pulmonary hospital

City

Shanghai

ZIP/Postal Code

200433

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Caicun zhou, MD, PhD

Phone

86-65115006-3050

caicunzhoudr@126.com

First Name & Middle Initial & Last Name & Degree

shengxiang Ren, MD,PhD

harry_ren@126.com

First Name & Middle Initial & Last Name & Degree

Shengxiang Ren, MD,PhD

First Name & Middle Initial & Last Name & Degree

Fengying Wu, MD,

First Name & Middle Initial & Last Name & Degree

Xiaoxia Chen, MD,PhD

First Name & Middle Initial & Last Name & Degree

Chunxia Su, MD,PhD

First Name & Middle Initial & Last Name & Degree

Caicun Zhou, MD,PhD

12. IPD Sharing Statement

Learn more about this trial

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

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