advanced malignancies (lymphoma, solid tumors)
Conditions
Interventions
MAK683 is adminitered orally once daily. The starting dose is 10mg.
Sponsors
Novartis Pharma K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2. 2. Patients with relapsed or refractory NHL with measurable disease as determined by Non-Hodgkin's Lymphoma Cheson response criteria (2014). 3. Patients with advanced or recurrent/metastatic malignancies, including nasopharyngeal carcinoma (with presence of p16/CDKN2A gene), castration-resistant prostate cancer, gastric cancer, OCCC and sarcoma, with measurable lesion as determined by RECIST 1.1.
Exclusion criteria
Exclusion criteria: 1. Other malignant diseases than the ones being treated in this study 2. Severe and/or uncontrolled medical conditions that in the investigator's opinion could affect the safety of individual or impair the assessment of study result. 3. B-cell lymphoma patients who have received prior allogeneic stem cell transplant 4. Patient have received anti-cancer therapies within defined time frames prior to the first dose of study treatment 5. Symptomatic central nervous system (CNS) involvement which are neurologically unstable or requiring increasing doses of steroids to control. 6. Unable to stop any prohibited medications, including strong cytochrome P450 (CYP) 3A4 inhibitors or inducers, long acting proton pump inhibitors and drugs with known risk of causing Torsades de pointes (TdP).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety exploratory Phase I: To characterize safety and tolerability and determine the MTD and/or RP2D ofMAK683 Phase II: To assess the anti-tumor activity of MAK683 | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy exploratory pharmacokinetics pharmacodynamics Phase I: -To characterize the anti-tumor activity of MAK683 -To characterize the PK profile of MAK683 -To characterize the pharmacodynamic effect of MAK683 Phase II: -To characterize the anti-tumor activity of MAK683 -To characterize the safety and tolerability of MAK683 -To characterize the PK profile of MAK683 -To characterize the pharmacodynamic effect of MAK683 | — |
Countries
Asia except Japan, Europe, Japan, North America
Contacts
Public ContactTakamitsu Hirano
Novartis Pharma K.K.
Outcome results
None listed