Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:01 PM
Ignite Modification Date:
2025-12-24 @ 1:01 PM
NCT ID:
NCT01934361
Eligibility 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 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 treatment with PI3K inhibitors, 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 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.
Other protocol-defined Inclusion/exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01934361
Study Brief:
Protocol Section:
NCT01934361