A Study of AUY922 in Non-small-cell Lung Cancer Patients Who Have Received Previous Two Lines of Chemotherapy.

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01124864
First received: May 14, 2010
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

This study will assess the efficacy of AUY922, when administered weekly at 70 mg/m2, in adult patients with advanced NSCLC, who have received at least two prior lines of chemotherapy. Patients will be retrospectively, and prospectively, stratified based on their molecular tumor etiology. The following strata will be assigned: Patients with EGFR activating mutations, Patients with Kras activating mutations, Patients with EML4-ALK translocations and patients that are both EGFR and Kras wild type.


Condition Intervention Phase
Non-small-cell Lung Cancer
Drug: AUY922
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II, Multi-center, Open-label Study of AUY922 Administered IV on a Once-weekly Schedule in Patients With Advanced Non-small-cell Lung Cancer Who Have Received at Least Two Lines of Prior Chemotherapy

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • To estimate efficacy for each study strata at 18 weeks as assessed by RECIST. [ Time Frame: 18 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Estimate Overall Survival [ Time Frame: Every 3 months after study treatment discontinuation ] [ Designated as safety issue: Yes ]
    Follow up with patient


Enrollment: 153
Study Start Date: October 2010
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EGFR mutant patients Drug: AUY922
Experimental: Kras mutant patients Drug: AUY922
Experimental: EGFR and Kras wild type patients Drug: AUY922
Experimental: Patients with EML4-ALK translocation Drug: AUY922
Experimental: EGFR mutant patients not received many lines of therapy Drug: AUY922

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with histologically or cytologically confirmed advanced (stage IIIB or stage IV) NSCLC who have received at least two prior lines of treatment. Patients who, in the investigators opinion, are deemed unsuitable for the standard 2nd line chemotherapy will be eligible for protocol participation. One of the prior lines must have included a platinum agent. Prior treatment with a platinum agent is not a requirement for EGFR mutant patients and patients with EML4-ALK translocations
  • Patients enrolled to the fifth stratum, modified EGFR mutant, must have documented prior response to EGFR TKI as defined by CR, PR or SD for 6 months or greater unless patient has de novo resistance to EGFR TKI (e.g. exon 20 insertions.)
  • All patients must have at least one measurable lesion as defined by RECIST criteria. Previously irradiated lesions are not measurable unless the lesion is new or has demonstrated clear progression after radiation
  • World Health Organization (WHO) performance status ≤ 2. For patients enrolled to the fifth stratum, modified EGFR mutant, World Health Organization (WHO) performance status ≤ 1
  • Patients enrolled to the fifth stratum, modified EGFR mutant, must be willing and suitable to undergo fresh baseline biopsy prior to study treatment (unless patient had recent biopsy after EGFR TKI progression that concluded resistance to EGFR TKI.)
  • Hematologic:

    • Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L.
    • Hemoglobin (Hgb) ≥ 9 g/dl.
    • Platelets (plt) ≥ 100 x 109/L.

Biochemistry:

  • Total calcium (corrected for serum albumin) within normal limits or correctable with supplements.
  • Magnesium within lower normal limits or correctable with supplements.

Adequate liver function defined as:

  • AST/SGOT and ALT/SGPT ≤ 3.0 x Upper limit of Normal (ULN) or ≤ 5.0 x ULN if liver metastasis are present.
  • Serum bilirubin ≤ 1.5 x ULN.
  • Serum albumin > 2.5 g/dL.
  • Serum creatinine ≤ 1.5 x ULN or 24 hour clearance ≥ 50 mL/min.

Exclusion Criteria:

  • Patients who have received more than four lines of prior treatment. Exception: Patients enrolled to the fifth stratum, modified EGFR mutant, must not have received more than two prior lines of therapy. Chemotherapy administered as adjuvant treatment more than six months prior to study enrollment is not considered a prior line of therapy for purposes of this study.
  • Patients with a history of CNS metastasis. Note: Patients without clinical signs and symptoms of CNS involvement are not required to have MRI of the brain. Exception: Patients with treated brain metastases who are asymptomatic, who has discontinued corticosteroids, and who have been clinically stable for one month will be eligible for protocol participation. This exception is not valid for patients enrolled to the fifth stratum, modified EGFR mutant. These patients must not have CNS involvement.
  • Prior anti-neoplastic treatment with any HSP90 or HDAC inhibitor compound.
  • Patients must not have received:

    • any systemic anti-cancer treatment or radiotherapy within 4 weeks prior to first dose of study treatment and should have recovered to baseline or less than Grade 1 from toxicities of such therapy prior to the first dose of study treatment
    • 2 weeks for palliative radiotherapy to bones, 6 weeks for nitrosoureas and mitomycin
    • 4 weeks for monoclonal antibodies
    • and ≤5 half-life of the agent or active metabolities [if any] for continuous systemic anti-cancer treatment or investigational
  • Patients who do not have either an archival tumor sample available or are unwilling to have a fresh tumor sample collected at baseline.

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01124864

Locations
United States, California
University of California at Los Angeles UCLA - Santa Monica
Los Angeles, California, United States, 90095
United States, Maryland
Associates in Oncology/Hematology, P.C. Dept. of Assoc. Onc/Hem
Rockville, Maryland, United States, 20850
United States, Massachusetts
Dana Farber Cancer Institute DFCI
Boston, Massachusetts, United States, 02115
United States, Pennsylvania
St. Luke's Hospital and Health Network St Luke's
Bethlehem, Pennsylvania, United States
Canada, Alberta
Novartis Investigative Site
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Quebec
Novartis Investigative Site
Montreal, Quebec, Canada, H3T 1E2
France
Novartis Investigative Site
Creteil, France, 94000
Novartis Investigative Site
Marseille cedex 20, France, 13915
Novartis Investigative Site
Villejuif Cedex, France, 94805
Germany
Novartis Investigative Site
Berlin, Germany, 13125
Novartis Investigative Site
Oldenburg, Germany, 26121
Korea, Republic of
Novartis Investigative Site
Seoul, Korea, Korea, Republic of, 135-710
Novartis Investigative Site
Seoul, Korea, Korea, Republic of, 110 744
Novartis Investigative Site
Seoul, Korea, Republic of, 137-701
Novartis Investigative Site
Seoul, Korea, Republic of, 738-736
Netherlands
Novartis Investigative Site
Amsterdam, Netherlands, 1081 HV
Novartis Investigative Site
Groningen, Netherlands, 9713 GZ
Norway
Novartis Investigative Site
Oslo, Norway, NO-0379
Singapore
Novartis Investigative Site
Singapore, Singapore, 119228
Spain
Novartis Investigative Site
Badalona, Catalunya, Spain, 08916
Novartis Investigative Site
Barcelona, Catalunya, Spain, 08035
Turkey
Novartis Investigative Site
Izmir, Turkey, 35040
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01124864     History of Changes
Other Study ID Numbers: CAUY922A2206, 2010-020116-11
Study First Received: May 14, 2010
Last Updated: May 27, 2014
Health Authority: United States: Food and Drug Administration
Netherlands: Medicines Evaluation Board (MEB)
Singapore: Clinical Trials & Epidemiology Research Unit (CTERU)
Canada: Health Canada
Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Norway: Norwegian Medicines Agency
South Korea: Korea Food and Drug Administration (KFDA)
Spain: Ministry of Health
Turkey: Ministry of Health

Keywords provided by Novartis:
Non-small-cell lung cancer
HSP90
2nd to 3rd line treatment

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014