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Completed Phase 2 Interventional Results available

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

ClinicalTrials.gov ID: NCT01297491

Public ClinicalTrials.gov record NCT01297491. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 24, 2026, 6:31 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01297491
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Novartis Pharmaceuticals
Industry
Enrollment
63 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 2011 (Type not available)
Primary completion
Oct 2014 (Actual)
Completion
Oct 2014 (Actual)
Last update posted
Mar 11, 2016

2011 – 2014

United States locations

U.S. sites
32
U.S. states
22
U.S. cities
29
Facility City State ZIP Site status
Ironwood Cancer and Research Centers SC Chandler Arizona 85224 —
Arizona Oncology Associates Tucson (Rudasill & La Cholla) Phoenix Arizona — —
Mayo Clinic - Arizona Mayo Scottsdale AZ Scottsdale Arizona 85259 —
Highlands Oncology Group Dept of Highlands Oncology Grp Fayetteville Arkansas 72753 —
Cedars Sinai Medical Center Dept.of Cedars-Sinai Med. Ctr. Los Angeles California 90048 —
University of California at San Diego, Moores Cancer Ctr SC San Diego California 92103 —
University of Colorado Univ CO Aurora Colorado 80045 —
Rocky Mountain Cancer Centers Dept. of Rocky Mountain Cancer Greenwood Village Colorado 80218 —
H. Lee Moffitt Cancer Center & Research Institute H Lee Moffitt Tampa Florida 33612 —
Emory University School of Medicine/Winship Cancer Institute Emory 2 Atlanta Georgia 30322 —
Rush University Medical Center SC Chicago Illinois 60612 —
University of Chicago Medical Center Unvi Chi Chicago Illinois 60637 —
University of Kansas Cancer Center Univ of KS Kansas City Kansas 66160 —
Massachusetts General Hospital Mass General Boston Massachusetts 02114 —
Fallon Clinic at Worcester Medical Center Fallon Clinic Worcester Med Worcester Massachusetts 01608 —
Karmanos Cancer Institute Wayne St Karmanos Detroit Michigan 48201 —
Washington University School of Medicine Washington University (16) St Louis Missouri 63110 —
Hematology Oncology Associates of Northern New Jersey PA DeptofHem-OncofNorthern NJ (2) Morristown New Jersey 07962 —
Overlook Hospital - Carol G Simon Cancer Center Carol G Simon Summit New Jersey 07901 —
Roswell Park Cancer Institute Rosewell Buffalo New York 14263 —
Memorial Sloan Kettering Cancer Center Sloan Kettering New York New York 90033 —
Duke University Medical Center Duke 2 Durham North Carolina 27710 —
MetroHealth Medical Center Dept.ofMetroHealthMedCtr.(2) Cleveland Ohio 44109-1998 —
University of Oklahoma Health Sciences Center Dept. of Oklahoma Univ. HSC Oklahoma City Oklahoma 73104 —
Northwest Cancer Specialists Compass Oncology -BKM Portland Oregon 97210 —
University of Pittsburgh Medical Center SC-2 Pittsburgh Pennsylvania 15213 —
Medical University of South Carolina MUSC Charleston South Carolina 29425 —
Baylor Health Care System/Sammons Cancer Center Baylor Texas Oncology Dallas Texas 75246 —
Texas Oncology South Texas Oncology Dallas Texas 75251 —
U of TX Southwestern Medical Center - SimmonsCompCancerCtr Clinical Research Office Dallas Texas 75390-9151 —
Virginia Oncology Associates VOA - Lake Wright (2) *see Various Departments* Virginia 23502 —
University of Wisconsin Univ WIsc 2 Madison Wisconsin 53792 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 60 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01297491, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 11, 2016 · Synced Oct 24, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01297491 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →