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Safety and Efficacy of MAK683 in Adult Patients With Advanced Malignancies

About

Brief Summary

The purpose of this study is to identify the safe dose of MAK683 and how many times a day this can be given to patients. Also, this study hopes to see if the study treatment stops the cells in tumors from growing abnormally.

The study has 2 main phases.

In Phase 1 part, a small group of patients will receive the MAK683 treatment. If no significant problems or side effects are observed, a second group of patients will be given a higher dose of the study treatment. This step-wise increase in doses will continue until the optimum dose of MAK683 is identified. This part of the study will include relapsed or refractory Diffuse large B-cell lymphoma (DLBCL), advanced or metastatic (cancer had been expend to other part of body) Nasopharyngeal carcinoma (NPC) and other advanced solid tumors.

In Phase 2 part, patients will receive the optimum dose of MAK683 that was found to be safe in Phase I part of the study. This part of study will include patients with specific types of cancer.

Subjects will be followed on 28 day cycles taking drug by mouth daily. During the first 2 cycles they will be seen weekly and after they will be seen twice a week for safety assessments (labs, physical exams, scans, etc.).

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase I/II

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Adult subjects with cancer large B cell lymphoma, follicular lymphoma, other B cell lymphoma. For more information about the eligibility criteria for this trial, refer to the Health Professional version.

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.
  • Patient having out of range laboratory values defined as:
  • 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

Join this Trial

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Study Stats
Protocol No.
16-001309
Category
Hematology-Oncology
Oncology
Location
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT02900651
For detailed technical eligibility, visit ClinicalTrials.gov.