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A Phase I, Two-stage, Multi-center, Open Label, Dose-escalation Study of BKM120 in Combination With Adjuvant Temozolomide and With Concomitant Radiation Therapy and Temozolomide in Patients With Newly Diagnosed Glioblastoma

Phase 1
18 Years
Open (Enrolling)

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Trial Information

A Phase I, Two-stage, Multi-center, Open Label, Dose-escalation Study of BKM120 in Combination With Adjuvant Temozolomide and With Concomitant Radiation Therapy and Temozolomide in Patients With Newly Diagnosed Glioblastoma

Inclusion Criteria:

- Patient is ≥ 18 years of age on the day of consent signature

- Patient with histologically demonstrated, previously untreated glioblastoma

- Patient may have received initial treatment for GBM as follows:

- For patients enrolled into Stage I, they must have received at least 75% of
planned radiotherapy (60 Gy) with temozolomide treatment during the concomitant
phase have documentation that the patient's absolute neutrophil count (ANC) is
≥ 1.5 x 109/L, platelet count is ≥ 100 x 109/L, and there was no CTC grade 2 or
above nonhematological toxicity (except for alopecia, nausea, vomiting) during
the concomitant phase treatment be within ≥ 4 weeks but ≤ 6 weeks following the
completion of temozolomide in the concomitant phase

- For patients enrolled into Stage II, they must be within ≥ 2 weeks but ≤ 6 weeks
after primary GBM resection/biopsy The patient must have recovered from the
definitive surgical procedure for GBM

- Patient is able to be assessed by periodic dynamic contrast enhanced magnetic
resonance imaging (DCE-MRI) scan

- Patient has Karnofsky performance status >= 60

- Patient has adequate bone marrow and organ function

Exclusion Criteria:

- Patient has received previous treatment with PI3K and/or mTOR inhibitors for GBM or
for pre-existing neoplasm transformed to GBM. Patient has received any prior
anti-neoplastic therapy for BKM, except for the treatment allowed in inclusion

- Patient has any tumor progression after definitive GBM resection/ biopsy, except for
the transformation from previous low grade glioma. Patient with a concurrent
malignancy or malignancy within 3 years of study enrollment (with the exception of
adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or
curatively resected cervical cancer)

- Patient who had not recovered to grade 1 or better from any adverse events (except
alopecia, nausea, vomiting) related to previous antineoplastic therapy before
screening procedures are initiated, as allowed in inclusion criteria

- Patient has any of the following baseline mood disorders (not attributable to GBM) as
judged by the Investigator or a Psychiatrist, or meets the cut-off score of ≥ 12 in
the PHQ- 9 or a cut-off of ≥ 15 in the GAD-7 mood scale for reasons not attributable
to GBM; or selects a positive response of '1, 2, 3' to question number 9 regarding
potential for suicidal thoughts or ideation in the PHQ-9 (independent of the total
score of the PHQ-9)

- Medically documented history of or active major depressive episode, bipolar disorder
(I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal
attempt or ideation, or homicidal ideation (immediate risk of doing harm to others)

- Active severe personality disorders (defined according to DSM-IV). Note: for patients
with psychotropic treatments ongoing at baseline, the dose and the schedule should
not be modified within the previous 6 weeks prior to start of study drug.

- ≥ CTCAE grade 3 anxiety

- Patient who is concurrently using any other approved or investigational
anti-neoplastic agent

- Patient who has undergone the following invasive procedures: Major surgical
procedure, open biopsy or significant traumatic injury < 14 days prior to starting
study drug or has not recovered from side effects of such therapy, anticipation of
need for invasive surgical procedure during the course of the study, biopsy within 7
days prior to starting study drug

- Patient has poorly controlled diabetes mellitus (HbA1c > 8%)

- Patient is currently receiving increasing or chronic treatment with corticosteroids
or another immunosuppressive agent

- Patient is currently receiving an enzyme inducing anti-epileptic drug. The patient
must have discontinued EIAED therapy for at least two weeks prior to starting study
drug. Non-enzyme inducing anti-epileptic medication is allowed, except those listed
in the protocol

Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose Limiting Toxicity (DLT)

Outcome Description:

Per DLT criteria as defined in protocol

Outcome Time Frame:

Concomitant phase (42 days), adjuvant phase cycle 1 (28-day cycle), adjuvant phase cycles 2 (28-day cycle)

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

December 2011

Completion Date:

July 2014

Related Keywords:

  • Glioblastoma
  • BKM120
  • temozolomide
  • glioblastoma multiforme
  • GBM
  • Newly diagnosed
  • Glioblastoma



Highlands Oncology Group Highlands Fayetteville, Arkansas  72703
Dana Farber Cancer Institute SC (1) Boston, Massachusetts  02115
MD Anderson Cancer Center/University of Texas MD Anderson DeGrout Houston, Texas  77030-4009