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

Primary Purpose

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

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

SNX-5422 Mesylate Hsp90 inhibitor

About this trial

This is an interventional treatment trial for Solid Tumor Malignancy

Eligibility Criteria

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

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

Sites / Locations

Pfizer Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm

Arm Description

Outcomes

Primary Outcome Measures

MTD, safety and toxicity

Secondary Outcome Measures

pharmacokinetic profile of SNX-5422

tumor response measured by X-rays or scans

Full Information

NCT ID

NCT00647764

First Posted

March 27, 2008

Last Updated

May 15, 2012

Sponsor

Esanex Inc.

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00647764

Brief Title

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

Official Title

Phase 1 Study Of SNX-5422 Mesylate In Adults With Refractory Solid Tumor Malignancies And Lymphomas

Study Type

Interventional

2. Study Status

Record Verification Date

May 2012

Overall Recruitment Status

Completed

Study Start Date

March 2008 (undefined)

Primary Completion Date

September 2010 (Actual)

Study Completion Date

September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Esanex Inc.

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

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

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single Arm

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

SNX-5422 Mesylate Hsp90 inhibitor

Intervention Description

dose escalated, tablets twice a week; undetermined duration until disease progression

Primary Outcome Measure Information:

Title

MTD, safety and toxicity

Time Frame

continuous

Secondary Outcome Measure Information:

Title

pharmacokinetic profile of SNX-5422

Time Frame

first cycle

Title

tumor response measured by X-rays or scans

Time Frame

after every 2 cycles

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

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

Bethesda

State/Province

Maryland

ZIP/Postal Code

20892

Country

United States

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1311003&StudyName=Safety%20Study%20Of%20SNX-5422%20To%20Treat%20Solid%20Tumor%20Cancers%20And%20Lymphomas

Description

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

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