An Observational Study of CPT-11 Based Regimens and UGT1A... | NCT01039506

Studies
An Observational Study of CPT-11 Based Regimens and UGT1A1 Genotypes in Metastatic Colorectal Cancer (mCRC)

NCT01039506

Sponsor

Daiichi Sankyo Co., Ltd.

Status

Completed

Last Update Posted

May 29, 2019Actual

Enrollment

1,376Actual

Phase

Not provided

Conditions

Metastatic Colorectal Cancer

Interventions

CPT-11 based regimens

Countries

Japan

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
090945	Other Identifier	JAPIC ID

Status Module

Record Verification Date

May 2019

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 15, 2009Actual

Primary Completion Date

Apr 28, 2016Actual

Completion Date

Jul 1, 2016Actual

First Submitted Date

Dec 23, 2009

First Submission Date that Met QC Criteria

Dec 23, 2009

First Posted Date

Dec 25, 2009Estimated

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

May 24, 2019

Last Update Posted Date

May 29, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The purpose of this study is to examine the correlation between UGT1A1 genotypes and the efficacy of CPT-11 based regimens (FOLFIRI, CPT-11+S-1, CPT-11) for patients with metastatic colorectal cancer.

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

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,376Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
UGT1A1 genotyped patients		UGT1A1 genotyped patients receive CPT-11 based regimens	Drug: CPT-11 based regimens

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CPT-11 based regimens	Drug		UGT1A1 genotyped patients	FOLFIRI, CPT-11+S-1, CPT-11

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression free survival	Percentage of participants alive without disease progression	Within 3 years

Secondary Outcomes

Measure	Description	Time Frame
Overall survival	Percentage of participants alive at end of study	At 3 years
Time to treatment failure	Duration of time (in months) from treatment to failure

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Metastatic colorectal cancer (adenocarcinoma)
UGT1A1 genotyped patients
Patients to receiving FOLFIRI, CPT-11+S-1 and CPT-11 alone therapy (with or without molecular targeted agents)

Exclusion Criteria:

Contraindication of CPT-11
Eastern Cooperative Oncology Group (ECOG) Performance Score (PS) 3-4
Patients to receiving CPT-11 as adjuvant chemotherapy
History of pelvic irradiation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with metastatic colorectal cancer treated with CPT-11 based regimens (FOLFIRI, CPT-11+S-1, CPT-11) in clinical practice in Japan

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Clinical Oncology, National Defense Medical College Hospital		Tokorozawa-shi	Saitama	359-8513	Japan

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
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077146	Irinotecan

Ancestor Terms

ID	Term
D002166	Camptothecin
D000470	Alkaloids
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided