Open-label, non-randomized, phase 2 study evaluating efficacy and safety of PQR309 in patients with relapsed or refractory primary CNS lymphoma

PIQUR Therapeutics AG0 sites50 target enrollmentFebruary 10, 2017

Overview

No summary available.

Registry

who.int

Start Date

February 10, 2017

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. \= 18 years of age.
•2\. Patient with histologically/cytologically confirmed PCNSL at first progression.
•3\. Relapsed or refractory PCNSL demonstrated by cranial MRI.
•4\. Presence of at least one lesion of bi\-dimensionally measurable disease on baseline MRI with a contrast\-enhancing tumor of at least 1 cm (10 mm) in the longest diameter.
•5\. Maximum two prior systemic therapy regimens excluding myeloablative therapy at first relapse.
•6\. If receiving corticosteroids, patients must have been on a stable or decreasing dose of corticosteroids and no more than 8 mg dexamethasone (or equivalent) for at least 5 days prior to date of enrollment.
•7\. Karnofsky Performance Score (KPS) \= 70%.
•8\. More than 4 weeks from any investigational agent (at the judgment of the investigator and in agreement with lead investigator and PIQUR).
•9\. Adequate haematological, liver and renal function defined as follows: absolute neutrophil count (ANC) \= 1\.5x10^9/l, platelets \= 100x10^9/l, hemoglobin \= 100g/L. Total bilirubin \= 1\.5 times the upper limit of normal (ULN). Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \= 2\.5 times ULN. Serum Creatinine \= 1\.5 times ULN.
•10\. Able and willing to swallow and retain oral medication.

•1\. Secondary CNS lymphoma or chronic immunosuppresion\-associated CNS lymphoma.
•2\. Previous allogeneic hematopoietic stem cell transplant (HSCT transplant).
•3\. Patients with persisting symptoms from previous whole brain radiotherapy (WBRT).
•4\. Other concomitant anti\-tumor therapy as determined by the study team.
•5\. Patients unable to undergo contrast\-enhanced MRI.
•6\. Prior treatment with a PI3K inhibitor, AKT inhibitor, or mTOR inhibitor.
•7\. Patient is currently using herbal preparations or medications. Patient should stop using herbal medications 7 days prior to the first dose of the study drug.
•8\. 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 (e.g. risk of doing harm to self or others), or patients with active severe personality disorders.
•9\. Anxiety \=CTC AE grade 3\.
•10\. Patient has an uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, known HIV infection, chronic liver disease, chronic renal disease, pancreatitis, chronic pulmonary disease, active cardiac disease or cardiac dysfunction, interstitial lung disease, active autoimmune disease, uncontrolled diabetes, neuropsychiatric or social situations that would limit compliance with the study requirements.