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Safety and Efficacy of BKM120 in Patients With Metastatic Non-small Cell Lung Cancer (BASALT-1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01297491
First received: February 11, 2011
Last updated: March 10, 2016
Last verified: March 2016
Results First Received: October 30, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Non-small Cell Lung Cancer
Intervention: Drug: BKM120

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Squamous BKM120 100mg qd Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
Non-Squamous BKM120 100mg qd Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.

Participant Flow:   Overall Study
    Squamous BKM120 100mg qd   Non-Squamous BKM120 100mg qd
STARTED   30   33 
COMPLETED   0   0 
NOT COMPLETED   30   33 
Adverse Event                11                6 
Physician Decision                3                2 
Progressive disease                11                20 
Patient/Guardian decision                3                4 
Death                2                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis set Stage 1 includes all patients who were enrolled during Stage 1 after meeting eligibility criteria and who have received at least one dose of study drug.

Reporting Groups
  Description
Squamous BKM120 100mg qd Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
Non-Squamous BKM120 100mg qd Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
Total Total of all reporting groups

Baseline Measures
   Squamous BKM120 100mg qd   Non-Squamous BKM120 100mg qd   Total 
Overall Participants Analyzed 
[Units: Participants]
 30   33   63 
Age, Customized 
[Units: Participants]
     
< 65 years   12   19   31 
>= 65 years   18   14   32 
Gender 
[Units: Participants]
     
Female   9   14   23 
Male   21   19   40 


  Outcome Measures
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1.  Primary:   Progression Free Survival (PFS) Rate as Per Investigator Local Review Measured Using RECIST 1.1 of Patients at Week 12   [ Time Frame: Week 12 ]

2.  Secondary:   Overall Survival (OS) Using Kaplan-Meier Estimates   [ Time Frame: Every 8 weeks up to 24 months ]

3.  Secondary:   Overall Response Rate (ORR) Based on Investigator Assessment   [ Time Frame: Every 6 weeks up to 24 months ]

4.  Secondary:   Disease Control Rate (DCR)   [ Time Frame: Every 6 weeks up tp 24 months ]

5.  Secondary:   Time to Response (TTR)   [ Time Frame: Every 6 weeks up to 24 months ]

6.  Secondary:   Duration of Response (DoR)   [ Time Frame: Every 6 weeks up to 24 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300
e-mail: trialandresults.registries@novartis.com


Publications of Results:

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01297491     History of Changes
Other Study ID Numbers: CBKM120D2201
2010-024011-14 ( EudraCT Number )
Study First Received: February 11, 2011
Results First Received: October 30, 2015
Last Updated: March 10, 2016
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: National Health Surveillance Agency
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Italy: National Institute of Health
Japan: Pharmaceuticals and Medical Devices Agency
Singapore: Health Sciences Authority
Spain: Spanish Agency of Medicines
Taiwan: Department of Health
Thailand: Food and Drug Administration
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency