Trial record 1 of 1 for:    NCT01297491
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Safety and Efficacy of BKM120 in Patients With Metastatic Non-small Cell Lung Cancer

This study is currently recruiting participants.
Verified February 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01297491
First received: February 11, 2011
Last updated: February 17, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Non-small Cell Lung Cancer
Drug: BKM120 or Docetaxel
Drug: BKM120 or Docetaxel or Pemetrexed
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Two-stage Study of Orally Administered BKM120 in Patients With Metastatic Non-small Cell Lung Cancer With Activated PI3K Pathway

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Progression Free Survival (PFS) as measured using RECIST 1.1 [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 122
Study Start Date: May 2011
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Squamous
can receive either BKM120 or Doctaxel
Drug: BKM120 or Docetaxel
Experimental: Non-Squamous
can receive BMK120 or Docetaxel or Pemetrexed
Drug: BKM120 or Docetaxel or Pemetrexed

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01297491

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

  Show 122 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01297491     History of Changes
Other Study ID Numbers: CBKM120D2201, 2010-024011-14
Study First Received: February 11, 2011
Last Updated: February 17, 2014
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
China: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hong Kong: Department of Health
Hungary: National Institute of Pharmacy
Italy: National Institute of Health
Japan: Pharmaceuticals and Medical Devices Agency
Korea: Food and Drug Administration
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
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

Keywords provided by Novartis:
NSCLC,
PI3K

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Pemetrexed
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on April 14, 2014