Safety and Efficacy of MAK683 in Adult Patients With Advanced Malignancies (NCT02900651) | Clinical Trial Compass
TerminatedPhase 1
Safety and Efficacy of MAK683 in Adult Patients With Advanced Malignancies
Stopped: The decision of early termination was made due to business reasons, and was not based on any safety or tolerability concerns for MAK683
United States, Canada, China139 participantsStarted 2016-10-03
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.