Safety and Efficacy of BKM120 in Patients With Metastatic Non-small Cell Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01297491
First received: February 11, 2011
Last updated: July 15, 2014
Last verified: July 2014

February 11, 2011
July 15, 2014
May 2011
February 2015   (final data collection date for primary outcome measure)
Progression Free Survival (PFS) as measured using RECIST 1.1 [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01297491 on ClinicalTrials.gov Archive Site
  • Determine Objective Response Rate (ORR) [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
  • Determine Time to Response (TTR) [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
  • Determine Duration of Response [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
  • Determine Overall Survival (OS) [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
  • Characterize safety as measured by frequency and severity of AEs and lab values [ Time Frame: Until 30 days after last dose ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of BKM120 in Patients With Metastatic Non-small Cell Lung Cancer
An Open Label Two-stage Study of Orally Administered BKM120 in Patients With Metastatic Non-small Cell Lung Cancer With Activated PI3K Pathway

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-small Cell Lung Cancer
  • Drug: BKM120 or Docetaxel
  • Drug: BKM120 or Docetaxel or Pemetrexed
  • Experimental: Squamous
    can receive either BKM120 or Doctaxel
    Intervention: Drug: BKM120 or Docetaxel
  • Experimental: Non-Squamous
    can receive BMK120 or Docetaxel or Pemetrexed
    Intervention: Drug: BKM120 or Docetaxel or Pemetrexed
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
63
February 2015
February 2015   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Belgium,   Brazil,   Canada,   France,   Germany,   Hong Kong,   Hungary,   Italy,   Japan,   Netherlands,   Singapore,   Spain,   Taiwan,   Thailand,   Turkey,   United Kingdom
 
NCT01297491
CBKM120D2201, 2010-024011-14
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
July 2014

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