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An Open-label, Randomized Phase II Study to Evaluate the Efficacy of AUY922 vs Pemetrexed or Docetaxel in NSCLC Patients With EGFR Mutations

NCT01646125 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2019-07-24

Study results available
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Summary

The purpose of this study was to determine if AUY922 had superior efficacy when compared to chemotherapy agents docetaxel or pemetrexed in patients whose tumor had EGFR mutations.

The primary purpose of this study was to compare the efficacy of AUY922, when administered i.v. on a once-weekly schedule at 70 mg/m2, versus docetaxel or pemetrexed in adult patients with advanced NSCLC, whose tumors harbored EGFR activating mutations, and had developed resistance to EGFR TKI.

Conditions

  • Advanced Non Small Cell Lung Cancer (NSCLC)

Interventions

DRUG

AUY922

AUY922 was to be given by i.v. once weekly at 70 mg/m2 until disease progression, death or any other reason for discontinuation from study treatment.

DRUG

Docetaxel

Docetaxel was to be given i.v. once every 3 weeks at 75 mg/m2 until progression or unacceptable toxicity

DRUG

Pemetrexed

Pemetrexed was to be given once every 3 weeks at 500 mg/m2 until progression or unacceptable toxicity

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-23
Primary Completion
2015-11-04
Completion
2015-11-04

Countries

  • United States
  • France
  • Hong Kong
  • Italy
  • Japan
  • Netherlands
  • Norway
  • Poland
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT01646125 on ClinicalTrials.gov