NCT01611623

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 in patients with cancer.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for phase_1 cancer

Timeline
Completed

Started May 2012

Shorter than P25 for phase_1 cancer

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

May 1, 2012

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

May 25, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 5, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

April 2, 2013

Status Verified

March 1, 2013

Enrollment Period

6 months

First QC Date

May 25, 2012

Last Update Submit

March 29, 2013

Conditions

Cancer

Keywords

Solid tumor malignancyHsp90

Outcome Measures

Primary Outcomes (1)

  • Number of patients with dose limiting toxicities

    Number of patients with dose limiting toxicities defined as Grade 3 or higher on the CTCAE version 4.03 clearly related to disease progression in each dose cohort during the first cycle of study drug administration

    First 28 day cycle

Secondary Outcomes (2)

  • Pharmacokinetic profiles of parent drug and metabolite

    Day 1 and Day 21 first cycle

  • Number of patients with adverse events as a measure of tolerability

    Day 28 of each cycle

Study Arms (1)

SNX-5422

EXPERIMENTAL

Open label administration of SNX-5422 tablets every other day for 21 days on a 28 day cycle. Dose escalation based on safety outcomes

Drug: SNX-5422

Interventions

SNX-5422DRUG

Tablets dose every other day; dose escalation based on safety

SNX-5422

Eligibility Criteria

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

You may qualify if:

  • \>18 years old histologically confirmed solid tumor malignancy refractory to available therapy or for which no therapy is available adequate organ function

You may not qualify if:

  • CNS malignancy significant GI disease at risk for prolonged QT interval

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neoplasms

Interventions

SNX-5422

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2012

First Posted

June 5, 2012

Study Start

May 1, 2012

Primary Completion

November 1, 2012

Study Completion

March 1, 2013

Last Updated

April 2, 2013

Record last verified: 2013-03