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

Primary Purpose

Hematologic Neoplasms

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

SNX-5422

About this trial

This is an interventional treatment trial for Hematologic Neoplasms focused on measuring Hematologic Malignancies Hsp90 Hematologic Malignancy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Pfizer Investigational Site
Pfizer Investigational Site
Pfizer Investigational Site
Pfizer Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm

Arm Description

Outcomes

Primary Outcome Measures

adverse events and other safety assessments

Secondary Outcome Measures

disease response specific to the hematological malignancy

Full Information

NCT ID

NCT00595686

First Posted

January 7, 2008

Last Updated

May 15, 2012

Sponsor

Esanex Inc.

Collaborators

Serenex, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00595686

Brief Title

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

Official Title

A Phase 1, Open-label, Dose-Escalation Study Of The Safety And Pharmacokinetics Of SNX-5422 Mesylate In Subjects With Refractory Hematological Malignancies

Study Type

Interventional

2. Study Status

Record Verification Date

May 2012

Overall Recruitment Status

Completed

Study Start Date

January 2008 (undefined)

Primary Completion Date

May 2010 (Actual)

Study Completion Date

May 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Esanex Inc.

Collaborators

Serenex, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hematologic Neoplasms

Keywords

Hematologic Malignancies Hsp90 Hematologic Malignancy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single Arm

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

SNX-5422

Intervention Description

dose escalated; tablets every other day; undetermined duration until disease progression

Primary Outcome Measure Information:

Title

adverse events and other safety assessments

Time Frame

continuous

Secondary Outcome Measure Information:

Title

disease response specific to the hematological malignancy

Time Frame

after every 2 cycles

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30912

Country

United States

Facility Name

Pfizer Investigational Site

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

Facility Name

Pfizer Investigational Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15232

Country

United States

Facility Name

Pfizer Investigational Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1311002&StudyName=Safety%20And%20Pharmacology%20Of%20SNX-5422%20Mesylate%20In%20Subjects%20With%20Refractory%20Hematological%20Malignancies

Description

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

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