NCT00647764

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2008

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

March 27, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 1, 2008

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

May 17, 2012

Status Verified

May 1, 2012

Enrollment Period

2.5 years

First QC Date

March 27, 2008

Last Update Submit

May 15, 2012

Conditions

Solid Tumor MalignancyLymphoid Malignancy (Lymphoma and CLL)LeukemiaLymphoma

Outcome Measures

Primary Outcomes (1)

  • MTD, safety and toxicity

    continuous

Secondary Outcomes (2)

  • pharmacokinetic profile of SNX-5422

    first cycle

  • tumor response measured by X-rays or scans

    after every 2 cycles

Study Arms (1)

Single Arm

EXPERIMENTAL
Drug: SNX-5422 Mesylate Hsp90 inhibitor

Interventions

SNX-5422 Mesylate Hsp90 inhibitorDRUG

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

Single Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Bethesda, Maryland, 20892, United States

Location

Related Links

MeSH Terms

Conditions

LymphomaLeukemia

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHematologic Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 27, 2008

First Posted

April 1, 2008

Study Start

March 1, 2008

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

May 17, 2012

Record last verified: 2012-05

Locations

US(1)