Safety and Efficacy of BKM120 in Relapsed and Refractory NHL

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01693614
First received: September 4, 2012
Last updated: August 15, 2014
Last verified: August 2014
  Purpose

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).


Condition Intervention Phase
Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma
Drug: BKM120
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    Objective Response rate is the number of patients in a cohort who experience either complete response (CR) or partial response (PR) during their follow-up after treatment start divided by the total number of patients included in the corresponding cohort


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    Progression-free survival (PFS) is the time from the date of treatment start to the date of the first documented progressive disease (PD) or death due to any cause

  • 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. ] [ Designated as safety issue: No ]
    Duration of response is the time from the date of first occurrence of complete response (CR) or partial response (PR) to the date of the first documented progressive disease (PD) or death due to any cause

  • 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. ] [ Designated as safety issue: No ]
    Overall survival (OS) is the time from treatment start to the date of death due to any cause

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Continuous, until 30 days after treatment stops ] [ Designated as safety issue: Yes ]
    Safety will be determined by type, frequency and severity of adverse events per CTCAEv4.03 and type, frequency and severity of laboratory toxicities per CTCAEv4.03. Patients will be followed up for the duration of the study


Estimated Enrollment: 66
Study Start Date: February 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diffuse Large B Cell Lymphoma Drug: BKM120
100 mg once a day
Experimental: Mantle Cell Lymphoma Drug: BKM120
100 mg once a day
Experimental: Follicular Lymphoma Drug: BKM120
100 mg once a day

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01693614

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

  Show 28 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01693614     History of Changes
Other Study ID Numbers: CBKM120Z2402, 2012-002208-41
Study First Received: September 4, 2012
Last Updated: August 15, 2014
Health Authority: United States: Food and Drug Administration
Italy: Ethics Committee

Keywords provided by Novartis:
Diffuse large B-cell lymphoma, Mantle cell lymphoma, Follicular lymphoma, PI3K inhibitor, Non-Hodgkin lymphoma, NHL

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Follicular
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on August 21, 2014