Safety And Pharmacology Of SNX-5422 Mesylate In Subjects... | NCT00595686

Studies
Safety And Pharmacology Of SNX-5422 Mesylate In Subjects With Refractory Hematological Malignancies

NCT00595686

Sponsor

Esanex Inc.

Status

Completed

Last Update Posted

May 17, 2012Estimated

Enrollment

25Actual

Phase

Phase 1

Conditions

Hematologic Neoplasms

Interventions

SNX-5422

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

ID	Type	Description	Link
SNX-5422-CLN1-002

Status Module

Record Verification Date

May 2012

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

Jan 2008

Primary Completion Date

May 2010Actual

Completion Date

May 2010Actual

First Submitted Date

Jan 7, 2008

First Submission Date that Met QC Criteria

Jan 7, 2008

First Posted Date

Jan 16, 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

May 15, 2012

Last Update Posted Date

May 17, 2012Estimated

Name	Class
Serenex, Inc.	INDUSTRY

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

Hsp90 is a chemical in the body that is involved in the promotion of cancer. SNX-5422 is an experimental drug that blocks Hsp90. It is being evaluated for safety and efficacy in patients with 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

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single Arm	Experimental		Drug: SNX-5422

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SNX-5422	Drug	dose escalated; tablets every other day; undetermined duration until disease progression	Single Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
adverse events and other safety assessments		continuous

Secondary Outcomes

Measure	Description	Time Frame
disease response specific to the hematological malignancy		after every 2 cycles

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

>18 years old
Karnofsky performance status > 60
confirmed hematological malignancy
refractory to available therapy or for which no therapy is available
adequate hepatic, renal and hematological function

Exclusion Criteria:

CNS malignancy
at risk for prolonged QT interval
significant GI/liver disease
other serious concurrent illness or medical condition

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
Pfizer CT.gov Call Center	Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Augusta	Georgia	30912	United States
Pfizer Investigational Site

References Module

Citations

Not provided

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases