Overview

This trial is active, not recruiting.

Condition diffuse large b-cell lymphoma, mantle cell lymphoma, follicular lymphoma
Treatment bkm120
Phase phase 2
Target PI3K
Sponsor Novartis Pharmaceuticals
Start date February 2013
End date December 2016
Trial size 72 participants
Trial identifier NCT01693614, 2012-002208-41, CBKM120Z2402

Summary

This is a phase II study evaluating the safety, tolerability and efficacy of BKM120 in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL) or follicular lymphoma (FL).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
bkm120
100 mg once a day

Primary Outcomes

Measure
Objective Response rate
time frame: Treatment continues in cycles of 28 days until disease progression, intolerable toxicity, other criteria for discontinuation, or 6 months after the last patient in that cohort has started BKM120, whichever comes first.

Secondary Outcomes

Measure
Progression-free survival
time frame: Every 2 cycles until disease progression, new anticancer therapy, lost to follow up, death, consent withdrawal or 6 months after the last patient in that cohort has started the study treatment, whichever comes first.
Duration of response
time frame: Every 2 cycles until disease progression,new anticancer therapy, lost to follow up, death, consent withdrawal or 6 months after the last patient in that cohort has started treatment, whichever comes first.
Overall survival
time frame: Every 2 cycles until disease progression, new anticancer therapy, lost to follow up, death, consent withdrawal, or 6 months after the last patient in that cohort has started treatment, whichever comes first.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
time frame: Continuous, until 30 days after treatment stops

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Patient has a histologically confirmed diagnosis of mantle cell lymphoma, follicular lymphoma, or diffuse large B cell lymphoma. 2. Patient has relapsed or refractory disease and received at least one prior therapy. 3. Patient with diffuse large B cell lymphoma has received or is ineligible for autologous or allogeneic stem cell transplant. 4. Patient has at least one measurable nodal lesion (≥2 cm) according to Cheson criteria (Cheson 2007). In case where the patient has no measurable nodal lesions ≥ 2 cm in the long axis at baseline, then the patient must have at least one measurable extra-nodal lesion. 5. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. 6. Patient has adequate bone marrow and organ function. Exclusion Criteria: 1. Patient has received previous treatment with PI3K inhibitors 2. Patient has evidence of graft versus host disease (GVHD). 3. Patient has active or history of central nervous system (CNS) disease. 4. Patient has a concurrent malignancy or has 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 has a score ≥ 12 on the PHQ-9 questionnaire. 6. Patient has a GAD-7 mood scale score ≥ 15. 7. Pregnant or nursing women 8. Patient who does not use highly effective contraception methods to avoid becoming pregnant or conceiving offspring. Other protocol-defined inclusion/exclusion criteria may apply.

Additional Information

Official title An Open-label Phase II Study of BKM120 in Patients With Relapsed and Refractory Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma and Follicular Lymphoma
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Novartis.