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Health Condition(s) or Problem
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Non-small Cell Lung Cancer
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Lay Summary
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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.
(from ClinicalTrials.gov)
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Who can enter the trial
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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
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Who cannot enter the trial
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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
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What will happen
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Drug; BKM120 or Docetaxel; Squamous; Drug; BKM120 or Docetaxel or Pemetrexed; Non-Squamous
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Primary aim
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Progression Free Survival (PFS) as measured using RECIST 1.1
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Secondary Aim
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Determine Objective Response Rate (ORR); Every 6 weeks; No; Determine Time to Response (TTR); Every 6 weeks; No; Determine Duration of Response; Every 6 weeks; No; Determine Overall Survival (OS); Every 6 weeks; No; Characterize safety as measured by frequency and severity of AEs and lab values; Until 30 days after last dose; Yes
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Participant Information Sheet
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Sorry, not currently available
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Website
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Sorry, not currently available
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Recruitment Status
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Recruiting
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Nation
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England
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Location
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Northwood, Leicester, London, Manchester
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