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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01646125
First received: June 26, 2012
Last updated: March 14, 2014
Last verified: March 2014

June 26, 2012
March 14, 2014
November 2012
October 2015   (final data collection date for primary outcome measure)
Progression Free Survival (PFS) [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01646125 on ClinicalTrials.gov Archive Site
  • Overall Survival (OS) [ Time Frame: from randomization until death up to death ] [ Designated as safety issue: No ]
    OS is defined as the time from the date of randomization to date of death due to any cause. If a death has not been observed by the date of analysis cutoff, then OS will be censored at the last known date patient was alive.
  • Overall Response Rate (ORR) [ Time Frame: baseline, until disease progression up to 24 months ] [ Designated as safety issue: No ]
    ORR will be compared between treatment arms. The ORR will be based on local investigator assessment per RECIST 1.1
  • Disease Control Rate (DCR) [ Time Frame: baseline, until disease progression up to 24 months ] [ Designated as safety issue: No ]
    Duration of DCR will be compared between treatment arms. The duration of DCR will be based on local investigator assessment per RECIST 1.1
  • Time to Response (TRR) [ Time Frame: baseline, until disease progression up to 24 months ] [ Designated as safety issue: No ]
    TTR will be compared between treatment arms. The TTR will be based on local investigator assessment per RECIST 1.1
  • Duration of Response (DOR) [ Time Frame: baseline, until disease progression up to 24 months ] [ Designated as safety issue: No ]
    The DOR will be compared between treatment arms. The DOR will be based on local investigator assessment per RECIST 1.1
  • Rate of Adverse Events (AEs) [ Time Frame: baseline, until disease progression up to 24 months ] [ Designated as safety issue: Yes ]
    To evaluate safety and tolerability of AUY922 compared to chemotherapy agents pemetrexed or docetaxel.
  • Rate of serious Adverse events (SAEs) [ Time Frame: baseline, until disease progression up to 24 months ] [ Designated as safety issue: Yes ]
    To evaluate safety and tolerability of AUY922 compared to chemotherapy agents pemetrexed or docetaxel.
  • Change in laboratory parameters [ Time Frame: baseline, until disease progression up to 24 months ] [ Designated as safety issue: Yes ]
    Changes in hematology and chemistry values, vital signs, electrocardiograms (ECGs), Dose interruptions, reductions and dose intensity.
  • Time to Progression (TTP) [ Time Frame: baseline, until disease progression up to 24 months ] [ Designated as safety issue: No ]
    TTP will be compared between treatment arms. The TTP will be based on local investigator assessment per RECIST 1.1
  • Overall Survival (OS) [ Time Frame: from randomization until death up to 24 months ] [ Designated as safety issue: No ]
    OS is defined as the time from the date of randomization to date of death due to any cause. If a death has not been observed by the date of analysis cutoff, then OS will be censored at the date of last contact.
  • Overall Response Rate (ORR) [ Time Frame: baseline, until disease progression up to 24 months ] [ Designated as safety issue: No ]
    ORR will be compared between treatment arms. The ORR will be based on local investigator assessment per RECIST 1.1
  • Disease Control Rate (DCR) [ Time Frame: baseline, until disease progression up to 24 months ] [ Designated as safety issue: No ]
    Duration of DCR will be compared between treatment arms. The duration of DCR will be based on local investigator assessment per RECIST 1.1
  • Time to Progression (TTP) [ Time Frame: baseline, until disease progression up to 24 months ] [ Designated as safety issue: No ]
    TTP will be compared between treatment arms. The TTP will be based on local investigator assessment per RECIST 1.1
  • Duration of Response (DOR) [ Time Frame: baseline, until disease progression up to 24 months ] [ Designated as safety issue: No ]
    The DOR will be compared between treatment arms. The DOR will be based on local investigator assessment per RECIST 1.1
  • Rate of Adverse Events (AEs) [ Time Frame: baseline, until disease progression up to 24 months ] [ Designated as safety issue: Yes ]
    To evaluate safety and tolerability of AUY922 compared to chemotherapy agents pemetrexed or docetaxel.
  • Rate of serious Adverse events (SAEs) [ Time Frame: baseline, until disease progression up to 24 months ] [ Designated as safety issue: Yes ]
    To evaluate safety and tolerability of AUY922 compared to chemotherapy agents pemetrexed or docetaxel.
  • Change in laboratory parameters [ Time Frame: baseline, until disease progression up to 24 months ] [ Designated as safety issue: Yes ]
    Changes in hematology and chemistry values, vital signs, electrocardiograms (ECGs), Dose interruptions, reductions and dose intensity.
Not Provided
Not Provided
 
An Open-label, Randomized Phase II Study to Evaluate the Efficacy of AUY922 vs Pemetrexed or Docetaxel in NSCLC Patients With EGFR Mutations
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 purpose of this study is to determine if AUY922 has superior efficacy when compared to chemotherapy agents docetaxel or pemetrexed in patients whose tumor have EGFR mutations.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Non Small Cell Lung Cancer (NSCLC)
  • Drug: AUY922
    AUY922 will be given i.v. once weekly at 70 mg/m2 until disease progression, death or any other reason for discontinuation from study treatment
  • Drug: Docetaxel
    Docetaxel will be given i.v. once every 3 weeks at 75 mg/m2 until progression or unacceptable toxicity
    Other Name: TAXOTERE
  • Drug: Pemetrexed
    Pemetrexed will be given once every 3 weeks at 500 mg/m2 until progression or unacceptable toxicity
    Other Name: ALIMTA
  • Experimental: AUY922 arm
    AUY922 will be administered weekly
    Intervention: Drug: AUY922
  • Active Comparator: chemotherapy arm
    docetaxel or pemetrexed will be given once every three weeks
    Interventions:
    • Drug: Docetaxel
    • Drug: Pemetrexed
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
108
October 2015
October 2015   (final data collection date for primary outcome measure)

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. This can be source - documented by one of the following:

    • Provide a pathology report that indicates the patient's tumor had EGFR activating mutation in the past.

    Or:

    • Perform testing (local or central) in an archival tumor or a fresh baseline biopsy tumor tissue to show the presence of EGFR activating mutation.

  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. WHO performance status of 0-1

Exclusion Criteria:

  1. Patients who have received more than two prior lines of antineoplastic therapy for advanced disease. Chemotherapy administered as neoadjuvant or adjuvant treatment more than six months prior to study enrollment is not considered a prior line of therapy for purposes of this study.
  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

Both
18 Years and older
No
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals
United States,   Australia,   France,   Hong Kong,   Italy,   Japan,   Korea, Republic of,   Netherlands,   Norway,   Poland,   Spain,   Taiwan,   United Kingdom
 
NCT01646125
CAUY922A2207, 2012-001050-25
No
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP