A Phase 2 interventional study of IPI 504 plus Docetaxel and Placebo plus Docetaxel in Non Small Cell Lung Cancer, sponsored by Infinity Pharmaceuticals, Inc.. Completed at 66 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-05-19.
Sponsored by Infinity Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment
The purpose of this study is to compare the impact of IPI-504 in combination with docetaxel to placebo in combination with docetaxel on life expectancy in patients with Non Small Cell Lung cancer (NSCLC). Docetaxel is an approved chemotherapy for NSCLC. An additional goal of the study is to determine the effect of IPI-504, in combination with docetaxel, verses placebo in, combination with docetaxel, on the growth of cancer
This is a Phase 2, double-blind, randomized, placebo-controlled study in patients with previously treated, locally advanced or metastatic Stage IIIb or IV NSCLC designed to compare IPI-504 plus docetaxel versus placebo plus docetaxel. All patients will have at least a 15 pack year smoking history. Tumor samples will be assessed by a central pathology reviewer to confirm pathology that is documented at baseline; this review need not occur in advance of randomization.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 226 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Infinity Pharmaceuticals, Inc. is the lead sponsor of 21 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: IPI-504 plus Docetaxel
Drug: IPI 504 plus Docetaxel
Placebo plus Docetaxel
Drug: Placebo plus Docetaxel
450 mg/m2 (starting dose) IPI-504 or placebo IV (in the vein) day 1, 8 \& 15 during each 21 day cycle 75 mg/m2 in US and EU, 60 mg/m2 in South Korea and Taiwan Docetaxel (Taxotere®) will be administered by IV infusion every 3 weeks (Day 1 of each 21-day cycle)
Also known as: IPI-504, Docetaxel
450 mg/m2 (starting dose) IPI-504 or placebo IV (in the vein) day 1, 8 \& 15 during each 21 day cycle 75 mg/m2 in US and EU, 60 mg/m2 in South Korea and Taiwan Docetaxel (Taxotere®) will be administered by IV infusion every 3 weeks (Day 1 of each 21-day cycle)
Also known as: Docetaxel
Overall Survival
To determine the overall survival rate of patients administered IPI-504 plus docetaxel vs. placebo plus docetaxel
Time frame: Up to three years from last patient study visit
Progression Free Survival
To determine the progression free survival rate from randomization to progression or death whichever occurs first, of all patients and in a subpopulation of patients administered IPI-504 plus docetaxel versus placebo plus docetaxel
Time frame: Up to three years from last patient study visit
Overall Response Rate
To determine partial response or complete response occurring at any point post-treatment
Time frame: Up to three years from last patient study visit
Time to Progression
To identify the amount of time from randomization to progression, of all patients and in a subpopulation of patients administered IPI-504 plus docetaxel versus placebo plus docetaxel
Time frame: Up to three years from last patient study visit
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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Infinity Pharmaceuticals, Inc.