Safety Study Of SNX-5422 To Treat Solid Tumor Cancers And... | NCT00647764

Studies
Safety Study Of SNX-5422 To Treat Solid Tumor Cancers And Lymphomas

NCT00647764

Sponsor

Esanex Inc.

Status

Completed

Last Update Posted

May 17, 2012Estimated

Enrollment

32Actual

Phase

Phase 1

Conditions

Solid Tumor Malignancy
Lymphoid Malignancy (Lymphoma and CLL)
Leukemia
Lymphoma

Interventions

SNX-5422 Mesylate Hsp90 inhibitor

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
PO7318

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

Mar 2008

Primary Completion Date

Sep 2010Actual

Completion Date

Sep 2010Actual

First Submitted Date

Mar 27, 2008

First Submission Date that Met QC Criteria

Mar 31, 2008

First Posted Date

Apr 1, 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
National Cancer Institute (NCI)	NIH

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 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

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single Arm	Experimental		Drug: SNX-5422 Mesylate Hsp90 inhibitor

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SNX-5422 Mesylate Hsp90 inhibitor	Drug	dose escalated, tablets twice a week; undetermined duration until disease progression	Single Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
MTD, safety and toxicity		continuous

Secondary Outcomes

Measure	Description	Time Frame
pharmacokinetic profile of SNX-5422		first cycle
tumor response measured by X-rays or scans		after every 2 cycles

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Solid tumors or lymphoid malignancies refractory to standard therapy
measurable disease
recovery to Grade < 1 toxicity due to prior adverse event or chemotherapy
no chemotherapy within 4 weeks of entering study
Age > 18 years
Karnofsy >= 60%
Life expectancy > 3 months
normal or adequate organ and marrow function

Exclusion Criteria:

receiving other investigational agents
brain metastases
uncontrolled medical illness
HIV+ receiving combination antiretroviral therapy
significant GI disease

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		Bethesda	Maryland	20892	United States

References Module

Citations

Not provided

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases

ID	Term
D008223	Lymphoma
D007938	Leukemia