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Safety and Efficacy of BKM120 in Patients With Metastatic Non-small Cell Lung Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT01297491•Novartis Pharmaceuticals

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+6 more criteria

Locations (92)

Ironwood Cancer and Research Centers SC

Chandler, Arizona, United States

Arizona Oncology Associates Tucson (Rudasill & La Cholla)

Phoenix, Arizona, United States

Mayo Clinic - Arizona Mayo Scottsdale AZ

Scottsdale, Arizona, United States

Highlands Oncology Group Dept of Highlands Oncology Grp

Fayetteville, Arkansas, United States

Cedars Sinai Medical Center Dept.of Cedars-Sinai Med. Ctr.

Los Angeles, California, United States

University of California at San Diego, Moores Cancer Ctr SC

San Diego, California, United States

University of Colorado Univ CO

Aurora, Colorado, United States

Rocky Mountain Cancer Centers Dept. of Rocky Mountain Cancer

Greenwood Village, Colorado, United States

H. Lee Moffitt Cancer Center & Research Institute H Lee Moffitt

Tampa, Florida, United States

Emory University School of Medicine/Winship Cancer Institute Emory 2

Atlanta, Georgia, United States

Key Dates

Start Date

May 1, 2011

Primary Completion Date

October 1, 2014

Completion Date

October 1, 2014

Last Updated

March 11, 2016

Enrollment

ACTUAL participants

Conditions

Non-small Cell Lung Cancer

Interventions

BKM120

DRUG

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

NCT07190248

Non-small Cell Lung Cancer

View study

RECRUITINGPHASE3

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

NCT06305754

Non-small Cell Lung Cancer (NSCLC)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 11, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)

Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment

Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations

Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)