Protocol Summary
Protocol No.
103706 (ARQ-531; MK-1026-001)
Principal Investigator
Stephens, Deborah
Phase
I/II
Age Group
Adult
ClinicalTrials.Gov
NCT03162536 (Click to jump to clinicaltrials.gov)
Eligibility Detail
Contact
Sheila Martinez
sheila.martinez@hci.utah.edu
Title
Phase 1/2 Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of ARQ 531 in Selected Subjects with Relapsed or Refractory Hematologic Malignancies
Objective
Primary Objectives
The primary objectives of this study are:
* To assess the safety and tolerability of ARQ 531 in selected subjects with relapsed or refractory hematologic malignancies.
* To determine the recommended Phase 2 dose (RP2D) and schedule of ARQ 531 for treatment of selected subjects with relapsed or refractory hematologic malignancies.
Secondary Objectives
The secondary objectives of this study are:
* To assess the PK profile of ARQ 531.
* To assess the pharmacodynamic (PD) activity of ARQ 531 in malignant cells.
* To generate preliminary evidence of anti-tumor activity.
Exploratory Objectives
* To evaluate the association between biomarkers, target inhibition, and clinical activity
Applicable Disease Sites
Experimental Therapeutics; Leukemia; Lymphoma
Participating Institutions
Huntsman Cancer Institute
Status
Open
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