Duration of Treatment With Tyrosine Kinase Inhibitors in... | NCT01585974

Studies
Duration of Treatment With Tyrosine Kinase Inhibitors in the Treatment of Metastatic Renal Cell Carcinoma

NCT01585974

Sponsor

Bayer

Status

Completed

Last Update Posted

Oct 19, 2016Estimated

Enrollment

151Actual

Phase

Not provided

Conditions

Renal Cell Carcinoma

Interventions

No intervention

Countries

Turkey (Türkiye)

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

ID	Type	Description	Link
NX1211TR	Other Identifier	company internal

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Jun 2015Actual

Completion Date

Nov 2015Actual

First Submitted Date

Apr 25, 2012

First Submission Date that Met QC Criteria

Apr 25, 2012

First Posted Date

Apr 26, 2012Estimated

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

Oct 18, 2016

Last Update Posted Date

Oct 19, 2016Estimated

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 study is a prospective, non-interventional, non-controlled, multi-center, observational cohort study. The medication is prescribed within the regular practice of the physician. Duration and dosage of treatment is solely at the discretion of the attending physician. The primary objective of this study is to assess duration of treatment in Turkish renal cell carcinoma patients treated with TKIs (Tyrosine Kinase Inhibitors) who could not tolerate prior cytokine treatment within the first month of treatment.

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

151Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1			Other: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	All dosage, frequency and duration for drugs will be under the decision of the treating physician	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Duration of treatment: from start of tyrosine kinase inhibitor treatment to permanent discontinuation of the product		After 2 years

Secondary Outcomes

Measure	Description	Time Frame
Incidence of treatment-emergent adverse events (TEAE)		After 2 years
Change of Tumor status		Baseline and 2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

To be diagnosed as metastatic renal cell carcinoma
Previous cytokine therapy
To sign informed consent form (ICF)

Exclusion Criteria:

Patients not willing to sign informed consent form or who withdraw their consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients diagnosed as metastatic renal cell carcinoma and could not tolerate previous cytokine therapy within the first month of treatment

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33050804	Derived	Benekli M, Gumus M, Ozkan M, Dane F, Elkiran ET, Cicin I, Sevinc A, Aliustaoglu M, Isikdogan A, Meydan N, Oksuzoglu B, Ozyilkan O, Artac M, Ozdemir F, Kilickap S. Tyrosine kinase inhibitors in the treatment of metastatic renal cell cancer patients with early cytokine intolerance: TURCOS, a Turkish national, prospective observational study. J Oncol Pharm Pract. 2021 Oct;27(7):1623-1630. doi: 10.1177/1078155220963535. Epub 2020 Oct 13.

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