Safety and Efficacy of BKM120 in Patients With Metastatic Non-small Cell Lu... | Completed
Safety and Efficacy of BKM120 in Pa... | Completed
Safety and Efficacy of BKM120 in Patients With Metastatic Non-small Cell Lung Cancer
BASALT-1
Trial Source

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Medical Conditions
  • Non-small Cell Lung Cancer
Unfortunately contact details are not available for this trial.
Primary Contact Details
Completed
Recruitment Status
NCT01297491
Primary Trial ID Number

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Summary
The purpose of this two-stage phase II study is to assess the efficacy of BKM120, as measured by determining the progression free survival (PFS), in patients with pretreated metastatic Non-small Cell Lung Cancer (NSCLC) that exhibits PI3K pathway activation. BKM120 will be investigated in two groups of NSCLC patients according to the histology of the cancer: squamous and non-squamous.
Research Details
    Sorry, this information is not available
Phase
Phase 2
Study Design
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Type
Interventional
Intervention
Drug : BKM120

Study Arm Groups : Squamous BKM120 100mg qd, Non-Squamous BKM120 100mg qd

Intervention Type
See Interventions above
Primary Outcome Measures
    Progression Free Survival (PFS) Rate as Per Investigator Local Review Measured Using RECIST 1.1 of Patients at Week 12; Week 12
Secondary Outcome Measures
    Overall Survival (OS) Using Kaplan-Meier Estimates; Every 8 weeks up to 24 months; Overall Response Rate (ORR) Based on Investigator Assessment; Every 6 weeks up to 24 months; Disease Control Rate (DCR); Every 6 weeks up tp 24 months; Time to Response (TTR); Every 6 weeks up to 24 months; Duration of Response (DoR); Every 6 weeks up to 24 months
Publication(s)
Vansteenkiste JF, Canon JL, Braud FD, Grossi F, De Pas T, Gray JE, Su WC, Felip E, Yoshioka H, Gridelli C, Dy GK, Thongprasert S, Reck M, Aimone P, Vidam GA, Roussou P, Wang YA, Di Tomaso E, Soria JC. Safety and Efficacy of Buparlisib (BKM120) in Patients with PI3K Pathway-Activated Non-Small Cell Lung Cancer: Results from the Phase II BASALT-1 Study. J Thorac Oncol. 2015 Sep;10(9):1319-27. doi: 10.1097/JTO.0000000000000607.; 26098748
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant Inclusion Criteria
    Inclusion Criteria:

    - Histologically confirmed NSCLC with activated PI3K pathway

    - Progressive disease after prior systemic antineoplastic treatment(s) for advanced NSCLC

    - Archival or fresh tumor biopsy must be available for profiling

    - Measurable and/or non-measurable disease as per RECIST 1.1 criteria

    - Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

    - Adequate organ function as assessed by laboratory tests

    Exclusion Criteria:

    - Patient has received previous treatment with PI3K inhibitors

    - Patient with squamous NSCLC has received more than one line of chemotherapy treatment for metastatic disease; patient with non-squamous NSCLC has received more than two lines of systemic antineoplastic treatment for metastatic disease

    - Uncontrolled or symptomatic CNS metastases

    - Concurrent use of any other approved or investigational antineoplastic agent

    - Radiotherapy ≤ 28 days prior to starting study drug

    - Major surgery within 28 days prior to starting study drug

    - History of clinically significant cardiac dysfunction, mood disorders, or poorly controlled diabetes mellitus

    - Current treatment with medication that has a known risk to prolong the QT interval or inducing Torsades de Pointes

    - Impairment of gastrointestinal (GI) function

    - Chronic treatment with steroids or another immunosuppressive agent.

    - Concurrent severe and/or uncontrolled medical condition

    - Currently receiving Warfarin or another coumarin derivative

    - Known history of HIV infection

    - Sensory neuropathy with functional impairment (CTC grade 2 neuropathy, regardless of causality)

    - Pregnancy, lactation, or breastfeeding

    - Woman of child-bearing potential

    Other protocol-defined inclusion/exclusion criteria may apply
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Manchester
M20 4BX
Leicester Royal Infirmary
Leicester
England
LE1 5WW
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood
England
HA6 2RN
Guy's Hospital
London
SE1 9RT
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Argentina, Belgium, Brazil, Canada, France, Germany, Hong Kong, Hungary, Italy, Japan, Netherlands, Singapore, Spain, Taiwan, Thailand, Turkey, United Kingdom, United States
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
An Open Label Two-stage Study of Orally Administered BKM120 in Patients With Metastatic Non-small Cell Lung Cancer With Activated PI3K Pathway
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
CBKM120D2201
Sponsor(s)
Novartis Pharmaceuticals
Key Dates

Recruitment Start Date

May 2011

Recruitment End Date

Oct 2014

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

11 Feb 2011

Last Updated

10 Mar 2016