Ovarian Cancer Clinical Trial
Safety and Efficacy of MAK683 in Adult Patients With Advanced Malignancies
The purpose of this Phase I/II study is to establish the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) and to evaluate the safety, antitumor activity and pharmacokinetic (PK) profile of MAK683 in patients with advanced malignancies such as Diffuse Large B cell Lymphoma (DLBCL), nasopharyngeal carcinoma (NPC) or other advanced solid tumors for whom no further effective standard treatment is available.
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.
Eastern Cooperative Oncology Group (ECOG): 0 to 2
Relapsed or refractory diffuse large B cell lymphoma with measurable disease as determined by Non-Hodgkin's Lymphoma Cheson response criteria (2014)
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.
Other malignant diseases than the ones being treated in this study
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.
B-cell lymphoma patients who have received prior allogeneic stem cell transplant
Patient have received anti-cancer therapies within defined time frames prior to the first dose of study treatment
Symptomatic central nervous system (CNS) involvement which are neurologically unstable or requiring increasing doses of steroids to control.
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)
Total bilirubin >1.5 x ULN
Serum creatinine > 1.5 x ULN and/or creatinine clearance ≤ 50 mL/min
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There are 15 Locations for this study
San Francisco California, 94115, United States
Santa Monica California, 90404, United States
Houston Texas, 77030, United States
Toronto Ontario, M5G 2, Canada
Shanghai Shanghai, 20003, China
Chengdu Sichuan, 61004, China
Villejuif Cedex Île-de-France, 94800, France
Freiburg , 79106, Germany
Koeln , 50937, Germany
Hong Kong , , Hong Kong
Milano MI, 20133, Italy
Rozzano MI, 20089, Italy
Fukuoka-city Fukuoka, 811-1, Japan
Sunto Gun Shizuoka, 411 8, Japan
Singapore , 16961, Singapore
Madrid , 28041, Spain
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