Study of MK0869 for the Prevention of Chemotherapy-Induce... | NCT00092196

Studies
Study of MK0869 for the Prevention of Chemotherapy-Induced Nausea and Vomiting (0869-071)(COMPLETED)

NCT00092196

Sponsor

Merck Sharp & Dohme LLC

Status

Completed

Last Update Posted

May 5, 2017Actual

Enrollment

820Actual

Phase

Phase 3

Conditions

Nausea
Vomiting
Breast Neoplasms

Interventions

MK0869, aprepitant / Duration of Treatment: 3 days

Countries

Not provided

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
2004_064

Official Title

Open-label Extension to: A Randomized, Double-Blind, Parallel-Group Study Conducted Under In-House Blinding Conditions to Determine the Efficacy and Tolerability of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting Associated With Moderately Emetogenic Chemotherapy

Status Module

Record Verification Date

May 2017

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

Dec 1, 2002Actual

Primary Completion Date

Dec 1, 2004Actual

Completion Date

Dec 1, 2004Actual

First Submitted Date

Sep 21, 2004

First Submission Date that Met QC Criteria

Sep 23, 2004

First Posted Date

Sep 24, 2004Estimated

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 2, 2017

Last Update Posted Date

May 5, 2017Actual

Description Module

Brief Summary

The purpose of this study is to determine the efficacy and tolerability of an investigational drug for the prevention of chemotherapy-induced nausea and vomiting associated with moderately emetogenic chemotherapy.

Detailed Description

Not provided

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

820Actual

Name	Type	Description	Arm Group Labels	Other Names
MK0869, aprepitant / Duration of Treatment: 3 days	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety and tolerability

Secondary Outcomes

Measure	Description	Time Frame
Assessment of adverse experiences using the National Cancer Institute (NCI) criteria

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient with a diagnosis of breast cancer requiring treatment with non-cisplatin moderately emetogenic chemotherapy.
Patient must have completed participation in the main study for this protocol.

Exclusion Criteria:

Patient has a central nervous system malignancy.
Patient will receive radiation to the abdomen or pelvis.

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

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Medical Monitor	Merck Sharp & Dohme LLC	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16104039	Background	Herrstedt J, Muss HB, Warr DG, Hesketh PJ, Eisenberg PD, Raftopoulos H, Grunberg SM, Gabriel M, Rodgers A, Hustad CM, Horgan KJ, Skobieranda F; Aprepitant Moderately Emetogenic Chemotherapy Study Group. Efficacy and tolerability of aprepitant for the prevention of chemotherapy-induced nausea and emesis over multiple cycles of moderately emetogenic chemotherapy. Cancer. 2005 Oct 1;104(7):1548-55. doi: 10.1002/cncr.21343.
15837996

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D009371	Neoplasms by Site

ID	Term
D000077608	Aprepitant
D000081206	Duration of Therapy

ID	Term
D009025	Morpholines
D010078	Oxazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

ID	Term
D009325	Nausea
D014839	Vomiting
D001943	Breast Neoplasms