Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
The purpose phase I of this trial is to characterize safety and tolerability and determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of MAK683.
The purpose of the phase II of this trial is to evaluate the anti-tumor activity of MAK683. Phase II part will not be opened.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Eastern Cooperative Oncology Group (ECOG): 0 to 2
2. Relapsed or refractory diffuse large B cell lymphoma with measurable disease as determined by Non-Hodgkin's Lymphoma Cheson response criteria (2014)
3. Advanced or recurrent/metastatic solid tumor, including nasopharyngeal carcinoma, castration-resistant prostate cancer, gastric cancer, ovarian clear cell carcinoma and sarcoma, with measurable disease as determined by RECIST 1.1.
You may not be if
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. Patient having out of range laboratory values defined as:
1\) Insufficient bone marrow function at screening:
Platelets ≤ 50,000/mm3
Hemoglobin (Hgb) ≤ 80 g/L
Absolute neutrophil count (ANC) ≤ 1000/mm3 2) Insufficient hepatic and renal function at screening:
ALP, ALT, and AST \> 3 x ULN (\>5 x ULN if subject has liver metastases)
