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A Phase I Dose Escalation Study of BKM120 With Radiation Therapy and Temozolomide in Patients With Newly Diagnosed Glioblastoma

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Disease Information

Descriptive Information
Brief Title † A Phase I Dose Escalation Study of BKM120 With Radiation Therapy and Temozolomide in Patients With Newly Diagnosed Glioblastoma
Official Title † 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
Brief Summary This clinical study will assess the doses of BKM120 appropriate for patients with newly diagnosed glioblastoma when given in combination with radiotherapy and temozolomide.
Detailed Description
Study Phase Phase 1
Study Type † Interventional
Study Design †
Primary Outcome Measure † Dose Limiting Toxicity (DLT)
Secondary Outcome Measure † No of participants with Adverse events based on abnormal laboratory results, abnormal electrocardiogram (ECG) findings
Condition † Glioblastoma
Intervention † DrugBKM120 + temozolomide
Study Arms / Comparison Groups BKM120 + Temozolomide (Concomitant Phase) Cranial radiation: Days 1 - 5 every 7 days for 42 days60 Gy in 30 fractions; Temozolomide: 75 mg/m2 Daily, orally; BKM120: 0, or 40, or 60, or 80 mg/d Daily, orally or Days 1-5 every 7 days, orally BKM120 + temozolomide with/without radiotherapy Adjuvant phase cycle 1: Temozolomide 150 mg/m2 - Days 1 - 5 every 28 days Daily; BKM120 60, or 80, or 100 mg/d; Adjuvant phase cycle 2+: Temozolomide 200* mg/m2 - Day 1 ~ 5 every 28 days Daily BKM120 0, or 40, or 60, or 80 or 100 mg/d
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 38
Start Date † December 30, 2011
Completion Date May 19, 2017
Primary Completion Date May 19, 2017
Eligibility Criteria † 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 criteria - 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 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
Gender All
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts ††
Location Countries † Australia
Administrative Information
NCT ID † NCT01473901
Organization ID CBKM120E2101
Secondary IDs †† 2011-001157-87
Responsible Party Sponsor
Study Sponsor † Novartis Pharmaceuticals
Collaborators ††
Investigators † Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Information Provided By
Verification Date May 2017
First Received Date † August 18, 2011
Last Updated Date May 4, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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