Multicenter, open-label, dose-escalation and pharmacokinetic study.
Multicenter, open-label, phase 1 study of DpC administered orally to patients with advanced solid tumors. The study will be conducted in two parts. In the first phase successive cohorts of patients (3+3) will receive escalating doses of DpC until the maximum tolerated dose (MTD) is reached. MTD is based on tolerability observed during the first 28 days of treatment. The second part of the study involves treatment of expansion cohorts (10-15 patients each) in specific indications to confirm the tolerability of treatment at the recommended phase 2 dose and schedule and evaluate evidence of anti-tumor activity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
iron chelator
Lifehouse Cancer Treatment Centre
Sydney, New South Wales, Australia
Olivia Newton John Cancer Centre
Heidelberg, Victoria, Australia
Monash Cancer Center
Melbourne, Victoria, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Recommended phase 2 dose as determined by number of participants at each dose level with dose limiting toxicities
Determine recommended phase 2 dose
Time frame: 36 months
Maximum DpC plasma concentration [Cmax] following dosing on Days 1 and 28 based on blood draws taken at 1, 2, 4, 8, and 24 hours after dosing
Maximum DpC plasma concentration
Time frame: 30 months
Area under the DpC plasma concentration vs. time curve [AUC] following dosing on Days 1 and 28 based on blood draws taken at 1, 2, 4, 8, and 24 hours after dosing
DpC area under the plasma concentration vs. time curve
Time frame: 30 months
Number of patients with tumor responses as assessed by RECIST criteria
number of tumor responses by RECIST criteria
Time frame: 36 months
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