An Extension Study for Patients Previously Treated With A... | NCT00622063

Studies
An Extension Study for Patients Previously Treated With ARQ 501

NCT00622063

Sponsor

ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)

Status

Completed

Last Update Posted

Feb 28, 2013Estimated

Enrollment

1Actual

Phase

Phase 1Phase 2

Conditions

Cancer

Interventions

ARQ 501

Countries

United States

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

Feb 2013

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 2006

Primary Completion Date

Sep 2008Actual

Completion Date

Not provided

First Submitted Date

Feb 12, 2008

First Submission Date that Met QC Criteria

Feb 12, 2008

First Posted Date

Feb 22, 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

Feb 21, 2013

Certification/Extension First Submitted that Passed QC Review

Feb 22, 2013

Certification/Extension First Posted Date

Feb 28, 2013Estimated

Last Update Submitted Date

Feb 22, 2013

Last Update Posted Date

Feb 28, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)INDUSTRY

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

To provide ongoing treatment with ARQ 501 for patients who have benefited from prior treatment with ARQ 501

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 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ARQ 501	Drug	Treatment with ARQ 501 or ARQ 501 as combination therapy at the dose and regimen previously received

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To provide ongoing treatment with ARQ 501 for patients who have benefited from prior treatment with ARQ 501		No time frame

Secondary Outcomes

Measure	Description	Time Frame
To collect additional safety and tolerability information for ARQ 501 treatment		No time frame

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed written informed consent
Has previous participated in a clinical trial with ARQ 501 and is eligible for continued treatment

Exclusion Criteria:

Have not received previous treatment with ARQ 501 under a treatment protocol
Uncontrolled intercurrent illness, uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Neil Nathan Senzer, MD	Mary Crowley Medical Research Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mary Crowley Medical Research Center		Dallas	Texas	75246	United States

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C014638	beta-lapachone

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided