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A Double-blind Study Evaluating IPI-504 and Docetaxel in Patients With Non-Small Cell Lung Cancer

NCT01362400 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 226

Last updated 2014-05-19

No results posted yet for this study

Summary

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

Conditions

  • Non Small Cell Lung Cancer

Interventions

DRUG

IPI 504 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)

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)

Sponsors & Collaborators

  • Infinity Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Tess Schmalbach, MD · Infinity Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2014-03-31
Completion
2014-04-30

Countries

  • United States
  • Hungary
  • Romania
  • Russia
  • South Korea
  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01362400 on ClinicalTrials.gov