Status:
TERMINATED
Safety and Efficacy of Buparlisib (BKM120) in Patients With Untreated Squamous Non-small Cell Lung Cancer
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Non-Small Cell Lunch Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
The Phase Ib part of the study aimed to determine the maximum tolerated dose/recommended Phase II dose (MTD/RP2D) of once daily buparlisib in combination with every-three-week carboplatin and paclitax...
Detailed Description
Based on the observation of DLTs and AEs, the safety profile of this investigational treatment was considered challenging requiring dose reductions/interruptions and even the evaluation of an alternat...
Eligibility Criteria
Inclusion
- Patient has histologically and/or cytologically confirmed diagnosis of squamous NSCLC. Diagnosis of mixed squamous with a squamous component will be acceptable for enrollment.
- Patient has archival or new tumor tissue for the analysis of PI3K biomarkers
- Tumor is Stage IV at the time of signed informed consent (UICC/AJCC version 7)
- Patient has measurable or non-measurable disease according to RECIST v1.1 criteria
- • For the Phase II portion, the patient must have measurable disease according to RECIST 1.1 criteria
- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 that the investigator believes is stable at the time of screening
- Patient has adequate bone marrow and organ function
Exclusion
- Patient has received any prior systemic therapies for metastatic NSCLC. Study treatment in this clinical trial must be the patient's first systemic treatment for metastatic NSCLC. Patients are eligible if they received neo-adjuvant or adjuvant systemic therapy followed by a disease-free interval exceeding 12 months.
- Patient has symptomatic CNS metastases
- • Patients with asymptomatic CNS metastases may participate in this trial. The patient must have completed any prior local treatment for CNS metastases ≥ 28 days prior to the start of study treatment (including radiotherapy and/or surgery, or ≥14 days for stereotactic radiosurgery).
- Patient is currently receiving warfarin or other coumadin derived anticoagulant for treatment, prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin (LMWH), or fondaparinux is allowed.
- Patient is currently receiving treatment with drugs known to be strong inhibitors or inducers of isoenzyme CYP3A. The patient must have discontinued strong inducers for at least one week and must have discontinued strong inhibitors before the treatment is initiated. Switching to a different medication prior to randomization is allowed.
- Patient has a medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (e.g. risk of doing harm to self or others) or patients with active severe personality disorders (defined according to DSM- IV) are not eligible. Note: for patients with psychotropic treatments ongoing at baseline, the dose and the schedule should not be modified within the previous 6 weeks prior to start of study drug
- Patient has ≥ CTCAE grade 3 anxiety
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (\> 5 mIU/mL)
- Patient who does not apply highly effective contraception during the study and through the duration as defined below after the final dose of study treatment.
Key Trial Info
Start Date :
September 9 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 18 2014
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01820325
Start Date
September 9 2013
End Date
June 18 2014
Last Update
October 11 2018
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Highlands Oncology Group
Fayetteville, Arkansas, United States, 72703
2
Northwest Cancer Specialists Compass Oncology -BKM
Portland, Oregon, United States, 97210
3
Novartis Investigative Site
Toronto, Ontario, Canada, M5G 1Z6
4
Novartis Investigative Site
Ulm, Germany, 89081