A Prospective Study on Sunitinib as First Line Therapy fo... | NCT02626754

Studies
A Prospective Study on Sunitinib as First Line Therapy for Advanced/Metastatic Renal Cell Carcinoma in Asian Population

NCT02626754

Sponsor

vghtpe user

Status

Terminated

Last Update Posted

Jun 26, 2018Actual

Enrollment

13Actual

Phase

Phase 2

Conditions

Renal Cell Carcinoma

Interventions

Sunitinib malate

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

In most sites had difficult to recruitting subjects.

Expanded Access Info

Start Date

Aug 12, 2015Actual

Primary Completion Date

Jan 2, 2018Actual

Completion Date

Jan 2, 2018Actual

First Submitted Date

Dec 1, 2015

First Submission Date that Met QC Criteria

Dec 7, 2015

First Posted Date

Dec 10, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 21, 2018

Last Update Posted Date

Jun 26, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

vghtpe user, Chief, Division of General Urology, Department of Urology, Taipei Veterans General Hospital, TaiwanSponsor-Investigator

Lead Sponsor

vghtpe userOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a multi-national, phase II, single arm study to explore the safety/efficacy and potential biomarkers on sunitinib 2/1 schedule for Asian patients with advanced renal cell carcinoma.

Detailed Description

Sunitinib 50mg daily on 4/2 dose schedule has been established as standard of care (SOC) for advanced renal cell carcinoma (RCC). However, Asian patients in real world experienced grade III/IV adverse events much more than expected. This multi-national, phase II, single arm study is going to explore more on the safety/efficacy and relevant biomarkers on sunitinib 2/1 dose schedule in Asian people with advanced RCC.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sunitinib	Experimental	Sunitinib malate, 12.5mg/capsule, 50mg/day	Drug: Sunitinib malate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sunitinib malate	Drug	Sunitinib 50mg will be given for 2 consecutive weeks then followed by one week of rest.	Sunitinib

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of treatment-emergent adverse events (safety and tolerability)	To evaluate the safety and tolerance of sunitinib two weeks on, one week off for advanced renal cell carcinoma	24 months

Secondary Outcomes

Measure	Description	Time Frame
Objective Response Rate (ORR)	to evaluate the best response rate of sunitinib 2/1 schedule	24 months
progression free survival (PFS)	to evaluate the progression-free survival of sunitinib 2/1 schedule

Other Outcomes

Measure	Description	Time Frame
single nuclear polymorphism	to explore the relationship between select SNP associated with sunitinib 2/1 schedule	24 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Advanced renal cell carcinoma with histology confirmation
Grade III/IV AEs happen during first cycle of sunitinib 50mg/day 4 weeks on followed by 2 weeks of rest
ECOG performance status 0 or 1
Appropriate vital organ functions

Exclusion Criteria:

Prior systemic treatment of mRCC
Patients treated with any neoadjuvant or adjuvant systemic therapy
Major surgery <4 weeks or radiation therapy <2 weeks of starting the study treatment. Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided there is at least one measurable lesion that has not been irradiated
Pregnant
Allergic history to sunitinib

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yen-Hwa Chang, M.D. Ph.D.	Taipei Veterans General Hospital, Taiwan	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kaohsiung Medical University Chung-HO Memorial Hospital		Kaohsiung City		80756	Taiwan
Kaohsiung Veterans General Hospital

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002292	Carcinoma, Renal Cell

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077210	Sunitinib

Ancestor Terms

ID	Term
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided