Phase I/II study of MAK683 single agent in patients with advanced malignancies
- Conditions
- advanced malignancies (lymphoma, solid tumors)
- Registration Number
- JPRN-jRCT2080223438
- Lead Sponsor
- ovartis Pharma K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 14
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.
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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method