Phase Ib/II Study of Buparlisib Plus Carboplatin or Lomustine in Patients With Recurrent Glioblastoma Multiforme
NCT ID: NCT01934361
Last Updated: 2020-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
35 participants
INTERVENTIONAL
2014-02-28
2016-07-07
Brief Summary
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A preliminary assessment for both combinations (buparlisib plus carboplatin or lomustine) demonstrated that there was not enough antitumor activity compared to historical data with single agent carboplatin or lomustine. Based on the overall safety profile, and preliminary anti-tumor activity observed in this study, Novartis decided that no additional patients would be enrolled into this study. As a consequence, the Phase II part of the study was not conducted.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Lomustine+ buparlisib (Phase Ib)
buparlisib
Buparlisib administered orally on a continuous daily schedule. Buparlisib is manufactured as 10mg and 50mg hard gelatin capsules.
lomustine
Lomustine will be administered as a single oral dose of 100 mg/m² every 6 weeks in a 42 day cycles.
carboplatin+ buparlisib (Phase Ib)
buparlisib
Buparlisib administered orally on a continuous daily schedule. Buparlisib is manufactured as 10mg and 50mg hard gelatin capsules.
carboplatin
Carboplatin intravenous infusion will be administered at a dose of AUC 5 in a 21 day cycle (every 3 weeks).
lomustine+ buparlisib (Phase II)
buparlisib
Buparlisib administered orally on a continuous daily schedule. Buparlisib is manufactured as 10mg and 50mg hard gelatin capsules.
lomustine
Lomustine will be administered as a single oral dose of 100 mg/m² every 6 weeks in a 42 day cycles.
lumustine + placebo (Phase II)
lomustine
Lomustine will be administered as a single oral dose of 100 mg/m² every 6 weeks in a 42 day cycles.
placebo
Placebo will be administered orally on a continuous QD dosing schedule for cycles of 42 days. Buparlisib matching placebo is manufactured as 10 mg and 50 mg hard gelatin capsules.
carboplatin+ buparlisib (Phase II)
buparlisib
Buparlisib administered orally on a continuous daily schedule. Buparlisib is manufactured as 10mg and 50mg hard gelatin capsules.
carboplatin
Carboplatin intravenous infusion will be administered at a dose of AUC 5 in a 21 day cycle (every 3 weeks).
Interventions
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buparlisib
Buparlisib administered orally on a continuous daily schedule. Buparlisib is manufactured as 10mg and 50mg hard gelatin capsules.
carboplatin
Carboplatin intravenous infusion will be administered at a dose of AUC 5 in a 21 day cycle (every 3 weeks).
lomustine
Lomustine will be administered as a single oral dose of 100 mg/m² every 6 weeks in a 42 day cycles.
placebo
Placebo will be administered orally on a continuous QD dosing schedule for cycles of 42 days. Buparlisib matching placebo is manufactured as 10 mg and 50 mg hard gelatin capsules.
Eligibility Criteria
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Inclusion Criteria
* Patient has histologically confirmed diagnosis of GBM with documented recurrence after first line treatment including radiotherapy and TMZ (SoC), not suitable for curative surgery or re-irradiation.
* Patient has at least one measurable and/or non-measurable lesion as per RANO criteria
* Patient has recovered (to Grade ≤1) from all clinically significant toxicities related to prior antineoplastic therapies.
* Patient has Karnofsky performance status (KPS) ≥70%.
* Patient has adequate organ and bone marrow functions:
* Absolute Neutrophils Count (ANC) ≥ 1.5 x 109/L
* Platelets ≥ 100 x 109/L (in case of transfusion stable for ≥14 days prior to treatment start)
* Hemoglobin ≥ 9.0 g/dL (in case of transfusion stable for ≥14 days prior to treatment start)
* INR ≤ 1,5
* Serum Creatinine ≤ 1.5 x ULN, or Creatinine Clearance \> 45mL/min
* Potassium and calcium (corrected for albumin), sodium and magnesium within institutional normal limits
* Serum Bilirubin ≤ ULN, AST and ALT ≤ ULN
* HbA1c ≤ 8%
* Fasting plasma glucose (FPG) ≤ 120 mg/dL or ≤ 6.7 mmol/L
* Patient has tumor tissues available (archival or fresh).
Exclusion Criteria
* Patient has received previous antineoplastic treatment for recurrent GBM (e.g. VEGF inhibitors, cytotoxic agents).
* Patient has received more than one line of cytotoxic chemotherapy
* Patient has concurrent use of anti-neoplastic agents including investigational therapy
* Patient is currently receiving warfarin or other coumarin derived anti-coagulant, for treatment, prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin (LMWH), or fondaparinux is allowed.
* Patient is currently receiving treatment with drugs known to be moderate or strong inhibitors or inducers of isoenzyme CYP3A. The patient must have discontinued strong inducers for at least one week and must have discontinued strong inhibitors before the treatment is initiated. Switching to a different medication prior to randomization is allowed.
* Patient is currently receiving an enzyme-inducing anti-epileptic drug (EIAED). The patient must have discontinued EIAED therapy for at least two weeks prior to starting study drug.
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Barrow Neurological Insitute St. Joseph's Hospital
Phoenix, Arizona, United States
Highlands Oncology Group
Fayetteville, Arkansas, United States
Northwestern University
Chicago, Illinois, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
MD Anderson Cancer Center/University of Texas
Houston, Texas, United States
Novartis Investigative Site
Heidelberg, Victoria, Australia
Novartis Investigative Site
Parkville, Victoria, Australia
Novartis Investigative Site
Leuven, , Belgium
Novartis Investigative Site
Toronto, Ontario, Canada
Novartis Investigative Site
Marseille, , France
Novartis Investigative Site
Paris, , France
Novartis Investigative Site
Saint-Herblain, , France
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
L'Hospitalet de Llobregat, Catalonia, Spain
Countries
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References
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Rosenthal M, Clement PM, Campone M, Gil-Gil MJ, DeGroot J, Chinot O, Idbaih A, Gan H, Raizer J, Wen PY, Pineda E, Donnet V, Mills D, El-Hashimy M, Mason W. Buparlisib plus carboplatin or lomustine in patients with recurrent glioblastoma: a phase Ib/II, open-label, multicentre, randomised study. ESMO Open. 2020 Jul;5(4):e000672. doi: 10.1136/esmoopen-2020-000672.
Related Links
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Results for CBMK120E2102 can be found on the Novartis Clinical Trial Results Website
Other Identifiers
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2013-003129-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CBKM120E2102
Identifier Type: -
Identifier Source: org_study_id