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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01693614 |
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Date of registration:
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04/09/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Safety and Efficacy of BKM120 in Relapsed and Refractory NHL
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Scientific title:
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An Open-label Phase II Study of BKM120 in Subjects With Relapsed and Refractory Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma and Follicular Lymphoma |
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Date of first enrolment:
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February 28, 2013 |
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Target sample size:
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72 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01693614 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Belgium
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Brazil
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France
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Germany
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Italy
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Korea, Republic of
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Spain
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Turkey
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United States
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Contacts
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Name:
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Novartis Pharmaceuticals |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novartis Pharmaceuticals |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Patient had a histologically confirmed diagnosis of mantle cell lymphoma, follicular
lymphoma, or diffuse large B cell lymphoma.
2. Patient had relapsed or refractory disease and received at least one prior therapy.
3. Patient with diffuse large B cell lymphoma had received or was ineligible for
autologous or allogeneic stem cell transplant.
4. Patient had at least one measurable nodal lesion (=2 cm) according to Cheson criteria
(Cheson 2007). In case where the patient had no measurable nodal lesions = 2 cm in the
long axis at baseline, then the patient must have had at least one measurable
extra-nodal lesion.
5. Patient had an Eastern Cooperative Oncology Group (ECOG) performance status = 2.
6. Patient had adequate bone marrow and organ function.
Exclusion Criteria:
1. Patient had received previous treatment with PI3K inhibitors
2. Patient had evidence of graft versus host disease (GVHD).
3. Patient had active or history of central nervous system (CNS) disease.
4. Patient had a concurrent malignancy or had a malignancy within 3 years of study
enrollment (with the exception of adequately treated basal or squamous cell carcinoma
or non-melanomatous skin cancer).
5. Patient had a score = 12 on the PHQ-9 questionnaire.
6. Patient had a GAD-7 mood scale score = 15.
7. Pregnant or nursing women
8. Patient who did not use highly effective contraception methods to avoid becoming
pregnant or conceiving offspring.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma
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Intervention(s)
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Drug: Buparlisib
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Primary Outcome(s)
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Overall Response Rate (ORR) and Disease Control Rate (DCR) Per Investigator at 6 Months (FAS)
[Time Frame: Baseline up to 6 months]
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Secondary Outcome(s)
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Overall Survival - Median (FAS)
[Time Frame: Baseline up approximately 44 months]
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Overall Survival (OS) - Percentage of Participants With OS Events (FAS)
[Time Frame: Baseline up to approximately 44 months]
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Progression- Free Survival (PFS) Based on Investigator Assessment (FAS)
[Time Frame: Baseline up to approximately 44 months]
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Percentage of Participants - Overall Survival- Kaplan Meier Estimates (FAS)
[Time Frame: Baseline up to approximately 18 months]
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Duration of Response for Diffuse Large B-cell Lymphoma (DLBCL), and Follicular Lymphoma (FL) Cohorts (FAS)
[Time Frame: Baseline up to approximately 18 months]
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Secondary ID(s)
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CBKM120Z2402
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2012-002208-41
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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