Brief Summary

The purpose of this study is to determine whether combining ganetespib (STA-9090) with docetaxel is more effective than docetaxel alone in the treatment of subjects with advanced non-small cell lung cancer.

Trial Health

Monitor

Trial Health Score

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

Enrollment

385

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started May 2011

Typical duration for phase_2

Geographic Reach

13 countries

53 active sites

Status

terminated

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

4.4 years study duration

Study Start

First participant enrolled

May 1, 2011

Completed

1 day until next milestone

First Submitted

Initial submission to the registry

May 2, 2011

Completed

3 days until next milestone

First Posted

Study publicly available on registry

May 5, 2011

Completed

2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed

1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed

Last Updated

November 5, 2015

Status Verified

November 1, 2015

Enrollment Period

2.9 years

First QC Date

May 2, 2011

Last Update Submit

November 4, 2015

Conditions

Non-small Cell Lung Cancer Stage IIIB Non-small Cell Lung Cancer Stage IV Non-small Cell Lung Cancer Metastatic

Keywords

Advanced non-small cell lung cancerNSCLCLung cancer

Outcome Measures

Primary Outcomes (1)

Progression-free survival in two co-primary populations
14 months

Secondary Outcomes (7)

Overall Response Rate
14 months
Determine qualitative and quantitative toxicities
14 months
Determine plasma drug concentrations of the combination
14 months
Evaluate Quality of Life
14 months
Disease Control Rate
14 months
+2 more secondary outcomes

Study Arms (2)

Single agent docetaxel

ACTIVE COMPARATOR

Drug: Docetaxel

Combination of ganetespib and docetaxel

EXPERIMENTAL

Drug: Combination of ganetespib and docetaxel

Interventions

DocetaxelDRUG

75 mg/m2 administered on Day 1 of a 3-week treatment cycle by 1-hour intravenous infusion

Single agent docetaxel

Combination of ganetespib and docetaxelDRUG

Ganetespib 150 mg/m2 in combination with docetaxel 75 mg/m2. On Day 1 of each 3-week treatment cycle, ganetespib and docetaxel will be administered as separate 1-hour intravenous infusions. Ganetespib 150 mg/m2 will be administered again on Day 15 of each cycle.

Combination of ganetespib and docetaxel

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

confirmed diagnosis of NSCLC
Stage IIIB or IV NSCLC
ECOG Performance Status 0 or 1
Prior therapy defined as 1 prior systemic therapy for advanced disease
measurable disease
Radiologic evidence of disease progression following most recent prior treatment.
Adequate hematologic, hepatic, renal function

You may not qualify if:

Active or untreated CNS metastases
Active malignancies other than NSCLC within the last 5 years with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin
Serious cardiac illness or medical conditions
Pregnant or lactating women
Uncontrolled intercurrent illness

Contact the study team to confirm eligibility.