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

Part of paid clinical trials in Fort Myers, Florida.

Sponsor
SCRI Development Innovations, LLC
Study ID
NCT01487265
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BKM120 and Erlotinib — DRUG
    BKM120 and Erlotinib will be given once daily. Erlotinib 100 mg PO will be administered. During Cycle 1-Week 1 all patients will receive 80 mg PO daily BKM120. After the first week of Cycle 1, the dose of BKM120 will escalate to 100 mg PO daily and treatment will continue as long as there are no unexpected or prohibitive toxicities, or disease progression.

Study Details

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.

Key Dates

First listed
Dec 7, 2011
Start date
Mar 31, 2014
Status verified
Feb 2019
Primary completion
May 31, 2016
Completion
Dec 11, 2017

Study Design

Enrollment
37 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: BKM120 and Erlotinib
    Cycle 1: BKM120 80 mg PO daily; Erlotinib 100mg PO daily Cycles 2 and beyond: BKM120 100 mg PO daily; Erlotinib 100mg PO daily

Primary Outcome Measure

Progression Free Survival at 3 Months [ Time Frame: 3 months ]

Locations (7)

FacilityCityStateZIPSite coordinators
Florida Cancer Specialists SouthFort MyersFlorida33916-
Florida Hospital Cancer InstituteOrlandoFlorida32804-
Florida Cancer Specialists NorthSt. PetersburgFlorida33705-
Florida Cancer Specialists EastWest Palm BeachFlorida33401-
Oncology Hematology Care, Inc.CincinnatiOhio45242-
Tennessee Oncology, PLLCNashvilleTennessee37023-
Center for Cancer and Blood DisordersFort WorthTexas76104-

Find similar trials in Fort Myers, FL

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Florida Cancer Specialists South· Fort Myers, FLFlorida Hospital Cancer Institute· Orlando, FLFlorida Cancer Specialists North· St. Petersburg, FLFlorida Cancer Specialists East· West Palm Beach, FLOncology Hematology Care, Inc.· Cincinnati, OHTennessee Oncology, PLLC· Nashville, TN

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