A Phase 1 Study Evaluating CB-5083 in Subjects With Lymphoid Hematological Malignancies

Official Title

A Phase 1, Dose-Escalation/Dose-Expansion Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamic Effects of Orally Administered CB-5083 in Subjects With Lymphoid Hematological Malignancies

Summary:

The purpose of this study is to determine the safety, tolerability, dose limiting toxicities, and maximum tolerated dose of CB-5083 in subjects with lymphoid hematological malignancies.

Trial Description

Primary Outcome:

  • To determine the dose limiting toxicities (DLTs) of oral CB-5083 in subjects with lymphoid hematological malignancies
  • To determine the pharmacokinetic (PK) profile of oral CB-5083 in subjects with lymphoid hematological malignancies by measuring the AUC
  • To determine the PK profile of oral CB-5083 in subjects with lymphoid hematological malignancies by measuring the Cmax
  • To determine the PK profile of oral CB-5083 in subjects with lymphoid hematological malignancies by measuring the Cmin
  • To determine the PK profile of oral CB-5083 in subjects with lymphoid hematological malignancies by measuring the Tmax
  • To determine the PK profile of oral CB-5083 in subjects with lymphoid hematological malignancies by measuring the T1/2
  • To confirm the safety and tolerability of oral CB-5083 administered to subjects with relapsed and refractory Multiple Myeloma at the maximum tolerated dose (MTD) at the end of the Dose Escalation Stage
  • To confirm the safety and tolerability of oral CB-5083 administered to subjects with relapsed/refractory DLBCL or Waldenstrom Macroglobulinemia at the MTD
Secondary Outcome:
  • To assess the pharmacodynamic (PD) effects of CB-5083 in peripheral blood cells and cancer cells
  • To further asses the PK profile of oral CB-5083 in subjects by measuring the AUC
  • To further asses the PK profile of oral CB-5083 in subjects by measuring the Cmax
  • To further asses the PK profile of oral CB-5083 in subjects by measuring the Cmin
  • To further asses the PK profile of oral CB-5083 in subjects by measuring the Tmax
  • To further asses the PK profile of oral CB-5083 in subjects by measuring the T1/2
  • To evaluate preliminary efficacy of oral CB-5083 in subjects, using standard response criteria

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society