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

Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

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
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 in a few days if the information you need is not here, or contact the researcher named above.
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: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Type
Interventional
Intervention
Drug : BKM120 or Docetaxel, Drug : BKM120 or Docetaxel or Pemetrexed

Study Arm Groups : Squamous, Non-Squamous

Intervention Type
See Interventions above
Primary Outcome Measures
  • Progression Free Survival (PFS) as measured using RECIST 1.1; Every 6 weeks
Secondary Outcome Measures
  • Determine Objective Response Rate (ORR); Every 6 weeks; Determine Time to Response (TTR); Every 6 weeks; Determine Duration of Response; Every 6 weeks; Determine Overall Survival (OS); Every 6 weeks; Characterize safety as measured by frequency and severity of AEs and lab values; Until 30 days after last dose
Publication(s)
Sorry, this information is not available
Result Reports
This is available 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 in a few days if the information you need is not here, or 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 in a few days if the information you need is not here, or 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 in a few days if the information you need is not here, or 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

Apr 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

26 Mar 2015

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