Brief Summary

Phase 2 study of subjects with ALK positive, advanced NSCLC who have failed up to 3 prior therapies. The study will take place globally at multiple study centers. Subjects will be enrolled to receive ganetespib one time per week for three weeks followed by a rest week; and will repeat this schedule until the cancer gets worse or the subject is unable to tolerate ganetespib. The primary goal of the study is to determine how ganetespib is tolerated and how active it is in ALK positive NSCLC.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at below P25 for phase_2

Timeline

Completed

Started Apr 2012

Geographic Reach

2 countries

5 active sites

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

2.6 years study duration

First Submitted

Initial submission to the registry

March 14, 2012

Completed

9 days until next milestone

First Posted

Study publicly available on registry

March 23, 2012

Completed

9 days until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed

2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed

Last Updated

May 20, 2015

Status Verified

May 1, 2015

Enrollment Period

2.3 years

First QC Date

March 14, 2012

Last Update Submit

May 18, 2015

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

Objective response rate
1 year

Secondary Outcomes (5)

Duration of Response
1 year
Disease Control Rate
6 weeks and 12 weeks
Adverse events
1 year
Progression Free Survival
From the date of study drug start until the date of first documented progression or date of death from any cause, whichever comes frist, assessed up to 3 years
Overall Survival
1 year

Study Arms (1)

Ganetespib

EXPERIMENTAL

Ganetespib IV infusion once per week for three consecutive weeks followed by a 1 week dose-free interval

Drug: Ganetespib

Interventions

GanetespibDRUG

Ganetespib 200 mg/m2 administered 1 time per week for the first three weeks of a four week treatment cycle (Days 1, 8, and 15 of the 28 Day treatment cycle).

Ganetespib

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Males or females aged 18 years or older
Pathological confirmation of advanced NSCLC
Evidence of a translocation or an inversion event involving the ALK gene locus
ECOG Performance Status 0 or 1

You may not qualify if:

Prior therapy with ALK-targeted agents
Prior treatment with Hsp90 inhibitor
Known EGFR activating mutation
Presence of active or untreated central nervous system (CNS) metastases

Contact the study team to confirm eligibility.