BKM120 for Patients With PI3K-activated Tumors
- Registration Number
- NCT01833169
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
The purpose of this signal seeking study was is to determine whether treatment with BKM120 demonstrates sufficient efficacy in select pathway-activated solid tumors and/or hematologic malignancies to warrant further study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 146
- Patient had a confirmed diagnosis of a solid tumor or hematological malignancy with the exception of endometrial cancer, glioblastoma, nonsmall cell lung cancer, prostate cancer or breast cancer.
- Patient's tumor was evaluated and pre-identified to have activation of the PI3K pathway, at a CLIA certified laboratory
- Patient must have received at least one prior treatment for recurrent metastatic and /or locally advanced disease and for whom no standard therapy options was anticipated to result in a durable remission.
- Patient must have had progressive and measurable disease as per RECIST 1.1. or other appropriate hematological guidelines
- Patient had an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
Patient had received previous treatment with BKM120 Patient had symptomatic CNS metastases Patient had mood disorder as outlined in Section 5 Patient had received chemotherapy or other anticancer therapy ≤ 4 weeks (6 weeks for nitrosourea, antibodies or mitomycin-C) prior to starting study drug.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BKM120 BKM120 BKM120 100 mg (oral gelatine capsules) was administered orally once daily starting from cycle 1 day 1 and will be dosed continuously every day for each 28- day cycle
- Primary Outcome Measures
Name Time Method Participant Clinical Benefit Response Rate Week 16 Clinical benefit rate for patients with solid tumors will be assessed using RECIST 1.1 and will include responses of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) at \>=16 weeks. For hematologic tumors other appropriate hematological response criteria was applied. Response criteria: CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm., PR=At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study, PD= At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline
- Secondary Outcome Measures
Name Time Method Progression-Free Survival (PFS)- Kaplan-Meier Estimates of PFS Rate in Percentages baseline up to 24 months Progression free survival (PFS) is defined as the time from the date of first dose to the date of first documented disease progression or relapse or death due to any cause.
Overall Survival - Number of Participants With an Event Every 8 Weeks until death, assessed up to 24 months Overall survival (OS) is defined as the time from the date of first dose to the date of death due to any cause. If a patient is not known to have died, survival time will be censored at the date of the last contact
Overall Survival (OS)- Kaplan-Meier Estimates of OS Timing in Months baseline up to 24 months Overall survival (OS) is defined as the time from the date of first dose to the date of death due to any cause. If a patient is not known to have died, survival time will be censored at the date of the last contact
Overall Response of Partial Response (PR) or Greater. PR=at Least a 30% Decrease in the Sum of Diameters of Target Lesions, Taking as Reference the Baseline Sum Diameters baseline and every 8 weeks until disease progression or end of treatment, assessed up to 24 months Overall Response (OR) of Partial Response (PR) or greater is based on local investigator assessment. For patients with solid tumors, the assessment criteria will be RECIST 1.1 and will include responses of CR and/or PR. For hematologic tumors other appropriate hematological response criteria apply
Progression-Free Survival - Number of Participants With an Event Every 8 Weeks until death, assessed up to 24 months Progression free survival (PFS) is defined as the time from the date of first dose to the date of first documented disease progression or relapse or death due to any cause
Progression-Free Survival (PFS)- Kaplan-Meier Estimates of PFS Timing in Months baseline up to 24 months Progression free survival (PFS) is defined as the time from the date of first dose to the date of first documented disease progression or relapse or death due to any cause
Overall Survival (OS)- Kaplan-Meier Estimates of OS Rate in Percentages baseline up to 30 months Overall survival (OS) is defined as the time from the date of first dose to the date of death due to any cause. If a patient is not known to have died, survival time will be censored at the date of the last contact
Trial Locations
- Locations (59)
Arizona Oncology Associates PC- HAL
🇺🇸Sedona, Arizona, United States
Bend Memorial Clinic Bend Mem. Clinic
🇺🇸Bend, Oregon, United States
Eastern Connecticut Hematology & Oncology Associates The Norwich Cancer Center
🇺🇸Norwich, Connecticut, United States
Abington Hematology Oncology Associates, Inc Abington Hem Onc Assoc (5)
🇺🇸Willow Grove, Pennsylvania, United States
Tyler Cancer Center
🇺🇸Tyler, Texas, United States
Cancer and Hematology Centers of West Michigan Dept. of Oncology
🇺🇸Grand Rapids, Michigan, United States
Texas Oncology, P.A. Texas Oncololgy, P.A. (8)
🇺🇸Fort Worth, Texas, United States
Illinois Cancer Care P.C. IL. Cancer Care
🇺🇸Peoria, Illinois, United States
Southeastern Regional Medical Center
🇺🇸Newnan, Georgia, United States
Salem Health
🇺🇸Salem, Oregon, United States
Illinois Cancer Care P.C.
🇺🇸Peoria, Illinois, United States
University of Iowa Hospitals & Clinics Regulatory Contact 2
🇺🇸Iowa City, Iowa, United States
West Cancer Clinic
🇺🇸Memphis, Tennessee, United States
Northwest Medical Specialties Hematology/Oncology
🇺🇸Tacoma, Washington, United States
Cancer Treatment Centers of America Southwestern Regional Med. Ctr
🇺🇸Schaumburg, Illinois, United States
Cancer Center at Presbyterian
🇺🇸Albuquerque, New Mexico, United States
Sanford University of South Dakota Medical Center Sanford Health
🇺🇸Sioux Falls, South Dakota, United States
Kadlec Clinic Hematology and Oncology Kadlec Clinic Hematology & Onc
🇺🇸Kennewick, Washington, United States
Gettysburg Cancer Center
🇺🇸Gettysburg, Pennsylvania, United States
West Penn Allegheny Oncology Network
🇺🇸Natrona Heights, Pennsylvania, United States
Blue Ridge Research Center at Roanoke Neurological Center McKesson Specialty Care
🇺🇸Roanoke, Virginia, United States
Sarcoma Oncology Center
🇺🇸Santa Monica, California, United States
Florida Cancer Specialists
🇺🇸West Palm Beach, Florida, United States
Lurie Children's Hospital of Chicago Developmental Therapeutics
🇺🇸Chicago, Illinois, United States
Cancer Care Specialists of Central Illinois
🇺🇸Decatur, Illinois, United States
Northern Indiana Cancer Research Consortium No. Indiana Cancer Res.
🇺🇸South Bend, Indiana, United States
New York Oncology Hematology NY Onc Hem
🇺🇸Albany, New York, United States
Mid Ohio Oncology/Hematology Mark H. Zangmeister Center
🇺🇸Columbus, Ohio, United States
Chattanooga Oncology and Hematology Assoicates, PC Chattanooga Oncology
🇺🇸Chattanooga, Tennessee, United States
Texas Oncology Sammons Cancer Center Sammons Cancer Center (10)
🇺🇸Dallas, Texas, United States
University of Pittsburgh Medical Center UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
Virginia Cancer Specialists Virginia Cancer Specialists
🇺🇸Fairfax, Virginia, United States
Texas Oncology P A Round Rock
🇺🇸Dallas, Texas, United States
Minnesota Oncology Hematology, P.A. Minnesota Oncology Hematology
🇺🇸Minneapolis, Minnesota, United States
Oncology Consultants Oncology Group
🇺🇸Houston, Texas, United States
Comprehensive Cancer Centers
🇺🇸Las Vegas, Nevada, United States
Duke University Medical Center Seeley G. Mudd Bldg.
🇺🇸Durham, North Carolina, United States
MD Anderson Cancer Center/University of Texas MD Anderson Cancer Center (3)
🇺🇸Houston, Texas, United States
Cancer Care Centers of South Texas HOAST CCC of So. TX-San Antonio (3)
🇺🇸San Antonio, Texas, United States
Hematology Oncology Associates of Northern New Jersey PA Regional Cancer Care Assoc.
🇺🇸Morristown, New Jersey, United States
Arizona Oncology Associates HOPE Division
🇺🇸Phoenix, Arizona, United States
Highlands Oncology Group
🇺🇸Fayetteville, Arkansas, United States
Rocky Mountain Cancer Centers RMCC - Aurora
🇺🇸Greenwood Village, Colorado, United States
Whittingham Cancer Center Norwalk Hospital
🇺🇸Norwalk, Connecticut, United States
Florida Cancer Specialists Dept of Oncology (2)
🇺🇸Fort Myers, Florida, United States
University Cancer & Blood Center, LLC
🇺🇸Athens, Georgia, United States
Eastern Maine Medical Center Research Center SC
🇺🇸Bangor, Maine, United States
Mount Auburn Hospital
🇺🇸Cambridge, Massachusetts, United States
Waverly Hematology Oncology
🇺🇸Cary, North Carolina, United States
Cleveland Clinic Foundation Cleveland Clinic (19)
🇺🇸Cleveland, Ohio, United States
Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States
Intermountain Medical Center Intermountain Healthcare
🇺🇸Murray, Utah, United States
Florida Hospital Cancer Institute FL Hosp. Cancer Instit.
🇺🇸Orlando, Florida, United States
Nebraska Cancer Specialists Oncology Hematology West
🇺🇸Omaha, Nebraska, United States
Michigan Medicine University of Michigan Int. Medicine Oncology
🇺🇸Ann Arbor, Michigan, United States
University of N C at Chapel Hill Physician Office Building
🇺🇸Chapel Hill, North Carolina, United States
Northwest Cancer Specialists Compass Oncology (36)
🇺🇸Portland, Oregon, United States
Oregon Health and Science University Oregon Health & Science U (56)
🇺🇸Portland, Oregon, United States
Medical College of Wisconsin Cancer Center
🇺🇸Milwaukee, Wisconsin, United States
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