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Completed Phase 2 Interventional Results available

Trial of Erlotinib and BKM120 in Patients With Advanced Non Small Cell Lung Cancer Previously Sensitive to Erlotinib

ClinicalTrials.gov ID: NCT01487265

Public ClinicalTrials.gov record NCT01487265. 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 19, 2026, 9:13 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

Phase II Trial of Erlotinib and BKM120 in Patients With Advanced Non Small Cell Lung Cancer Previously Sensitive to Erlotinib

Brief summary

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

Preclinical data in lung cancer cell lines showed that EGFR mutation can potentially be a positive predictor for sensitivity to BKM120. Furthermore, when the erlotinib-resistant model H1975 (LR858 and T790M mutation) was treated with BKM120, significant tumor control was observed (Novartis internal data). Therefore, combining BKM120 with erlotinib could potentially down-modulate PI3K-Akt activity resulting in a synergistic effect on cell growth inhibition and enhancing the response to erlotinib.

Study identification

NCT ID
NCT01487265
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Enrollment
37 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
Mar 2014 (Type not available)
Primary completion
May 31, 2016 (Actual)
Completion
Dec 11, 2017 (Actual)
Last update posted
Mar 6, 2019

2014 – 2017

United States locations

U.S. sites
7
U.S. states
4
U.S. cities
7
Facility City State ZIP Site status
Florida Cancer Specialists South Fort Myers Florida 33916 —
Florida Hospital Cancer Institute Orlando Florida 32804 —
Florida Cancer Specialists North St. Petersburg Florida 33705 —
Florida Cancer Specialists East West Palm Beach Florida 33401 —
Oncology Hematology Care, Inc. Cincinnati Ohio 45242 —
Tennessee Oncology, PLLC Nashville Tennessee 37023 —
Center for Cancer and Blood Disorders Fort Worth Texas 76104 —

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

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01487265, 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 6, 2019 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01487265 live on ClinicalTrials.gov.

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