This is an open-label, Phase I/Ib, dose escalation study of intravenous RXDX-107 administered to subjects with advanced solid tumors. The study is designed to explore the safety, maximum tolerated dose (MTD), pharmacokinetics, pharmacodynamics, and preliminary clinical activity of RXDX-107 and to define a recommended Phase 2 dose (RP2D)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Subjects in this study will receive RXDX-107 intravenously at dose levels specified for their respective dose cohorts. Dosing will begin at 25 mg/m2 on Day 1 and Day 2 of a 28-day cycle and will escalate until the maximum tolerated dose (MTD) or (RP2D) is determined. An additional schedule of administration of RXDX-107 on Day 1 of a 28 day cycle may be assessed. Cycles will be repeated in four-week (28 day) intervals for up to 6 cycles or until progression of disease, unacceptable toxicity, or another discontinuation criterion is met.
Florida Cancer Specialists
Sarasota, Florida, United States
Johns Hopkins Medical Institute
Baltimore, Maryland, United States
Tennessee Oncology, LLC
Nashville, Tennessee, United States
Phase 1: Safety profile of RXDX-107 as characterized by Adverse Events, ECG and laboratory abnormalities
AEs, ECG and Labs assessed according to NCI CTCAE V4.0
Time frame: Approx. 1 year
Phase 1: Maximum observed plasma drug concentration (Cmax)
Plasma concentrations obtained following the dose on Day 1 (and from the dose on Day 2 in patients receiving the Day 1 and Day 2 schedule)
Time frame: Approx. 1 year
Phase 1: Time to Cmax, by inspection (tmax)
Plasma concentrations obtained following the dose on Day 1 (and from the dose on Day 2 in patients receiving the Day 1 and Day 2 schedule)
Time frame: Approx. 1 year
Phase 1: Area under the drug concentration by time curve (AUC)
From time 0 to the time of the last detectable plasma concentration (AUC0-t)
Time frame: Approx. 1 year
Phase 1: Apparent plasma terminal elimination rate constant (λz) and associated terminal half life (t½)
Plasma concentrations obtained following the dose on Day 1 (and from the dose on Day 2 in patients receiving the Day 1 and Day 2 schedule)
Time frame: Approx. 1 year
Phase 1: Plasma clearance (CL)
Plasma concentrations obtained following the dose on Day 1 (and from the dose on Day 2 in patients receiving the Day 1 and Day 2 schedule)
Time frame: Approx. 1 year
Phase 1: Volume of distribution (Vz)
Plasma concentrations obtained following the dose on Day 1 (and from the dose on Day 2 in patients receiving the Day 1 and Day 2 schedule)
Time frame: Approx. 1 year
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Phase 1: Maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D)
Time frame: Approx. 6 months
Phase 1b: Confirm RP2D
Number of participants with Treatment-related AEs, Labs changes from baseline, and QTc interval changes from baseline assessed according to NCI CTCAE V4.0, concomitant medication usage, including all supportive care provided, and preliminary anti-tumor activity per RECIST v1.1 as assessed by Investigator
Time frame: Approx. 1 year
Antitumor activity of RXDX-107 as measured by Objective Response Rate (ORR)
Per RECIST v1.1 as assessed by Investigator
Time frame: Approx. 1 year