A Study to Evaluate the Safety, Tolerability, Pharmacokin... | NCT00750178

Studies
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK0683 in Patients With Advanced Cancer (0683-008)

NCT00750178

Sponsor

Merck Sharp & Dohme LLC

Status

Completed

Last Update Posted

Apr 7, 2017Actual

Enrollment

30Actual

Phase

Phase 1

Conditions

Cancer, Advanced

Interventions

vorinostat (MK0683 )

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

Status Module

Record Verification Date

Apr 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

Nov 1, 2004Actual

Primary Completion Date

Aug 1, 2005Actual

Completion Date

Nov 1, 2005Actual

First Submitted Date

Sep 8, 2008

First Submission Date that Met QC Criteria

Sep 9, 2008

First Posted Date

Sep 10, 2008Estimated

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

Apr 5, 2017

Last Update Posted Date

Apr 7, 2017Actual

Description Module

Brief Summary

This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MK0683 in patients with advanced cancer.

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	MK0683	Drug: vorinostat (MK0683 )

Interventions

Name	Type	Description	Arm Group Labels	Other Names
vorinostat (MK0683 )	Drug	Panel A: vorinostat 400 mg capsules once daily on Days 1, 5, 7-28 Total treatment period is 28 days	A

Measure	Description	Time Frame
Safety, tolerability, and PK of MK0683		28 Days

Measure	Description	Time Frame
Urinary excretion of MK0683		28 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients 18 years or older
Must agree to consume high fat meal and agree to fasting conditions
Limit alcohol consumption

Exclusion Criteria:

Patient has a history of drug or alcohol abuse within 5 years of start of study
Patient is known to have HIV
Patient has participated in another investigational study within 4 weeks of start of study
Patient cannot stop taking certain medications or herbal remedies
Patient will require immunologic, radiation, surgery, or chemotherapy during the study
Patient requires frequent blood transfusions
Female patient is pregnant or nursing
Patient has an active Hepatitis B or C infection

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
17145826	Result	Rubin EH, Agrawal NG, Friedman EJ, Scott P, Mazina KE, Sun L, Du L, Ricker JL, Frankel SR, Gottesdiener KM, Wagner JA, Iwamoto M. A study to determine the effects of food and multiple dosing on the pharmacokinetics of vorinostat given orally to patients with advanced cancer. Clin Cancer Res. 2006 Dec 1;12(23):7039-45. doi: 10.1158/1078-0432.CCR-06-1802.

ID	Term
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds

ID	Type	Description	Link
MK0683-008
2008_544