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A Multicenter, Open-label, Randomized Phase II Study to Evaluate the Efficacy of AUY922 vs Pemetrexed or Docetaxel in NSCLC Patients With EGFR Mutations Who Have Progressed on Prior EGFR TKI Treatment


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Advanced Non Small Cell Lung Cancer (NSCLC)

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Trial Information

A Multicenter, Open-label, Randomized Phase II Study to Evaluate the Efficacy of AUY922 vs Pemetrexed or Docetaxel in NSCLC Patients With EGFR Mutations Who Have Progressed on Prior EGFR TKI Treatment


The primary purpose of this study is 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 harbor EGFR activating mutations, and have developed
resistance to EGFR TKI.


Inclusion Criteria:



1. Patients with histologically or cytologically documented, locally advanced (stage
IIIB who are not amenable to combined modality treatment) or recurrent or metastatic
(Stage IV) non-small cell lung cancer.

2. Patients must have EGFR gene mutation in their tumors

3. Patients must have documented clinical benefit (CR, PR, or patients with SD for 6
months or greater) on prior EGFR TKI (e.g. erlotinib or gefitinib) followed by
documented progression according to RECIST.

4. Patients must have received prior platinum containing treatment.

5. Patients must be suitable and willing to undergo mandatory baseline biopsy according
to treating institution's own guidelines and requirements for such procedure.

Exclusion Criteria:

1. Patients who have received more than two prior lines of antineoplastic therapy for
advanced disease.

2. Evidence of spinal cord compression or current evidence of CNS metastases. Screening
CT/MRI of the brain is mandatory. Note: Patients who have been treated for CNS
metastases by radiation or gamma knife surgery, who been stable for at least 2 months
and have discontinued high dose corticosteroids will be eligible for protocol
participation

3. Prior treatment with an HSP90 inhibitor

Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival (PFS)

Outcome Description:

To compare PFS between the treatment of AUY922 to comparators Pemetrexed or Docetaxel. PFS will be based on local investigator assessment per RECIST 1.1

Outcome Time Frame:

up to 12 months

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CAUY922A2207

NCT ID:

NCT01646125

Start Date:

November 2012

Completion Date:

February 2015

Related Keywords:

  • Advanced Non Small Cell Lung Cancer (NSCLC)
  • HSP90, AUY922, Pemetrexed, Docetaxel, EGFR TKI, EGFR mutations, NSCLC, non small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Cedars Sinai Medical Center Dept.of Cedars-Sinai Med. Ctr.Los Angeles, California  90048
Associates in Oncology/Hematology, P.C. SCRockville, Maryland  20850
University of California at Los Angeles David Geffen School - UCLALos Angeles, California  90095
Norton Cancer Institute Clinical Research ProgramLouisville, Kentucky  40202
Dana Farber Cancer Institute DFCI AUYBoston, Massachusetts  02115
Arena Oncology Associates, PC SC LocationLake Success, New York  11042
University of Wisconsin / Paul P. Carbone Comp Cancer Center Univ Wisc 5Madison, Wisconsin  53792-6164