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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-001157-87 | EudraCT Number |
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This clinical study will assess the doses of BKM120 appropriate for patients with newly diagnosed glioblastoma when given in combination with radiotherapy and temozolomide.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BKM120 + Temozolomide (Concomitant Phase) | Experimental | 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 |
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| BKM120 + temozolomide with/without radiotherapy | Experimental | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BKM120 + temozolomide | Drug | The investigational drug, BKM120, will be supplied as 10-mg and 50-mg hard gelatin capsules. BKM120 will be administered on a once daily dosing schedule at a dose of 40 mg, or 60 mg, or 80 mg, or 100 mg (p.o.), in combination with the approved dosing of temozolomide and SoC delivery of cranial irradiation for GBM. The patient will be dosed with BKM120 on a flat scale of mg/day and the dose of BKM120 will not be adjusted to body weight or body surface area. Patients should not eat for 2 hours after the administration of BKM120. Temozolomide in 5 mg, 20 mg, 100 mg, 140 mg, 180 mg or 250 mg capsules will be administered in combination with the investigational drug BKM120. |
| Measure | Description | Time Frame |
|---|---|---|
| Dose Limiting Toxicity (DLT) | Per DLT criteria as defined in protocol | Concomitant phase (42 days), adjuvant phase cycle 1 (28-day cycle), adjuvant phase cycles 2 (28-day cycle) |
| Measure | Description | Time Frame |
|---|---|---|
| No of participants with Adverse events based on abnormal laboratory results, abnormal electrocardiogram (ECG) findings | Per common terminology criteria for adverse events (CTCAE) criteria (version 4.0) | Baseline, 30 days post the last BKM120 treatment |
| Objective response rate (ORR) |
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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:
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:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Highlands Oncology Group Highlands Oncology | Fayetteville | Arkansas | 72703 | United States | ||
| Dana Farber Cancer Institute SC (1) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32661186 | Derived | Wen PY, Rodon JA, Mason W, Beck JT, DeGroot J, Donnet V, Mills D, El-Hashimy M, Rosenthal M. Phase I, open-label, multicentre study of buparlisib in combination with temozolomide or with concomitant radiation therapy and temozolomide in patients with newly diagnosed glioblastoma. ESMO Open. 2020 Jul;5(4):e000673. doi: 10.1136/esmoopen-2020-000673. |
| Label | URL |
|---|---|
| Results for CBKM120E2101 can be found on the Novartis Clinical Trial Results Website | View source |
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| BKM120 +temozolomide with/without radiotherapy | Drug | The investigational drug, BKM120, will be supplied as 10-mg and 50-mg hard gelatin capsules. BKM120 will be administered on a continuous once daily dosing schedule at a dose of 40 mg, or 60 mg, or 80 mg, or 100 mg (p.o.), in combination with the approved dosing of temozolomide and SoC delivery of cranial irradiation for GBM. The patient will be dosed with BKM120 on a flat scale of mg/day and the dose of BKM120 will not be adjusted to body weight or body surface area. Patients should not eat for 2 hours after the administration of BKM120. Temozolomide in 5 mg, 20 mg, 100 mg, 140 mg, 180 mg or 250 mg capsules will be administered in combination with the investigational drug BKM120. |
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Antitumor activity will be assessed using the Neuro-Oncology Working Group updated response assessment criteria for high grade gliomas - per RANO criteria. |
| Baseline, 18 months after first BKM120 treatment |
| Progression free survival (PFS) | Per patient survival follow up feedbacks | at 12 months and at 18 months |
| Overall survival (OS) | Per patient survival follow up feedbacks | Until death or consent withdrawal |
| Plasma concentration-time profiles and basic pharmacokinetic parameters of BKM120 and temozolomide (Cmax, tmas, AUC, half-life) | Standard bioanalytical-pharmacokinetic (PK) analysis on PK samples for BKM120 and temozolomide. | baseline, Day 1, 8, 15, 28 in concomitant phase, Cycle 1 Day 1, 5 and Cycle 2 Day1, 5 at adjuvant phase (28-day per cycle) |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| University of Texas/MD Anderson Cancer Center MD Anderson DeGrout | Houston | Texas | 77030-4009 | United States |
| Novartis Investigative Site | Melbourne | Victoria | 3000 | Australia |
| Novartis Investigative Site | Hamilton | Ontario | L8V 5C2 | Canada |
| Novartis Investigative Site | Toronto | Ontario | M5G 1Z6 | Canada |
| Novartis Investigative Site | Barcelona | Catalonia | 08035 | Spain |
| Novartis Investigative Site | Madrid | 28040 | Spain |
| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| C571178 | NVP-BKM120 |
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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