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

May 15, 2012 updated by: Esanex Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Pfizer Investigational Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Pfizer Investigational Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • Pfizer Investigational Site
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Single Arm
Drug: SNX-5422
dose escalated; tablets every other day; undetermined duration until disease progression

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
adverse events and other safety assessments
Time Frame: continuous
continuous

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Esanex Inc.

Collaborators

Serenex, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (ACTUAL)

May 1, 2010

Study Completion (ACTUAL)

May 1, 2010

Study Registration Dates

First Submitted

January 7, 2008

First Submitted That Met QC Criteria

January 7, 2008

First Posted (ESTIMATE)

January 16, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

May 17, 2012

Last Update Submitted That Met QC Criteria

May 15, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B1311002
  • SNX-5422-CLN1-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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