Protocol Summary

Protocol No.

103706 (ARQ-531)

Principal Investigator

Stephens, Deborah

Phase

I

Age Group

Adult

ClinicalTrials.Gov

NCT03162536 (Click to jump to clinicaltrials.gov)

Eligibility Detail

Contact

Kolleen Hicks
Sr Clinical Research Coordinator
+1 801-587-7604
kolleen.hicks@hci.utah.edu

Title

Phase I 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


Clinical trials search powered by Forte Research Systems

FORTE