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

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

Sponsors

Lead sponsor: Esanex Inc.

Collaborator: National Cancer Institute (NCI)

Source Esanex Inc.
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.

Overall Status Completed
Start Date March 2008
Completion Date September 2010
Primary Completion Date September 2010
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
MTD, safety and toxicity continuous
Secondary Outcome
Measure Time Frame
pharmacokinetic profile of SNX-5422 first cycle
tumor response measured by X-rays or scans after every 2 cycles
Enrollment 32
Condition
Intervention

Intervention type: Drug

Intervention name: SNX-5422 Mesylate Hsp90 inhibitor

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

Arm group label: Single Arm

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Pfizer CT.gov Call Center Study Director Pfizer
Location
facility Pfizer Investigational Site
Location Countries

United States

Verification Date

May 2012

Responsible Party

Name title: Director, Clinical Trial Disclosure Group

Organization: Pfizer, Inc.

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: Single Arm

Arm group type: Experimental

Study Design Info

Allocation: Non-Randomized

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov