Phase Ib/II study of buparlisib plus carboplatin or lomustine in patients with recurrent glioblastoma multiforme

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 184

Inclusion Criteria

Inclusion Criteria: - Patient is an adult ? 18 years old at the time of informed consent. - 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 reirradiation. 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).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 92
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 92

Exclusion Criteria

Exclusion Criteria: - Patient has received previous treatment with lomustine or carboplatin. - 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 two weeks prior to starting study drug. Other protocol-defined Inclusion/exclusion criteria may apply.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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