Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

BKM120 for Patients With PI3K-activated Tumors (SIGNATURE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01833169
Recruitment Status : Completed
First Posted : April 16, 2013
Results First Posted : December 12, 2017
Last Update Posted : October 19, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( 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.

Condition or disease Intervention/treatment Phase
PI3K Pathway Activated Tumors Drug: BKM120 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 146 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Modular Phase II Study to Link Targeted Therapy to Patients With Pathway Activated Tumors: Module 1 - BKM120 for Patients With PI3K-activated Tumors
Actual Study Start Date : March 29, 2013
Actual Primary Completion Date : September 26, 2016
Actual Study Completion Date : September 26, 2016


Arm Intervention/treatment
Experimental: 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
Drug: 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 :
  1. Participant Clinical Benefit Response Rate [ Time Frame: 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 :
  1. 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 [ Time Frame: 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

  2. Progression-Free Survival - Number of Participants With an Event [ Time Frame: 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

  3. Progression-Free Survival (PFS)- Kaplan-Meier Estimates of PFS Timing in Months [ Time Frame: 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

  4. Progression-Free Survival (PFS)- Kaplan-Meier Estimates of PFS Rate in Percentages [ Time Frame: 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.

  5. Overall Survival - Number of Participants With an Event [ Time Frame: 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

  6. Overall Survival (OS)- Kaplan-Meier Estimates of OS Timing in Months [ Time Frame: 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

  7. Overall Survival (OS)- Kaplan-Meier Estimates of OS Rate in Percentages [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01833169


Locations
Show Show 59 study locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Layout table for investigator information
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Layout table for additonal information
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01833169    
Other Study ID Numbers: CBKM120ZUS40
First Posted: April 16, 2013    Key Record Dates
Results First Posted: December 12, 2017
Last Update Posted: October 19, 2018
Last Verified: October 2018
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Solid tumor
malignancy
hematologic malignancy
PI3K pathway activation
P13K activated tumors
BKM120
signature
AML
acute myelogenous leukemia
cervical
ovarian
hepatobiliary
buparlisib
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms