Phase 1 Dose Escalation Study of ARQ 087 in Adult Subjects With Advanced Solid Tumors
This is an open-label, Phase 1, dose escalation study of oral ARQ 087 administered to subjects with advanced solid tumors. The study is designed to explore the safety, tolerability, pharmacokinetics, and pharmacodynamics of ARQ 087 and to define a recommended Phase 2 dose.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1 Dose Escalation Study of ARQ 087 in Adult Subjects With Advanced Solid Tumors|
- Assess the safety and tolerability of ARQ 087 in subjects with advanced solid tumors by monitoring frequency and severity of adverse events [ Time Frame: Up to treatment discontinuation + 30 days with an estimated treatment duration of 4 to 24 weeks ] [ Designated as safety issue: Yes ]
- Assess the pharmacokinetic profile of ARQ 087 [ Time Frame: During the first 28 days of treatment for each dose level ] [ Designated as safety issue: No ]Blood sampling to assess the pharmacokinetic profile of ARQ 087.
- Assess pharmacodynamic activity [ Time Frame: Up to treatment discontinuation ] [ Designated as safety issue: No ]Blood and tumor sampling to provide information on fibroblast growth factor (FGF/FGFR) signalling pathway biomarkers.
- Determine preliminary evidence of activity as defined by standard imaging assessments [ Time Frame: Up to treatment discontinuation + 30 days with an estimated treatment duration of 4 to 24 weeks ] [ Designated as safety issue: No ]
- Determine recommended Phase 2 dose [ Time Frame: Up to treatment discontinuation + 30 days with an estimated treatment duration of 4 to 24 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
|Experimental: ARQ 087||
Drug: ARQ 087
Subjects in this study will receive ARQ 087 orally at dose levels specified for their respective dose cohorts. Dosing will begin at 25 mg every other day (QOD) and will escalate until the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) is determined. Cycles will be repeated in four-week (28 day) intervals until progression of disease, unacceptable toxicity, or another discontinuation criterion is met. In the case of toxicity, dose adjustment will be permitted.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01752920
|Contact: ArQule, Inc.||781-994-0300||ClinicalTrials@arqule.com|
|United States, Michigan|
|Detroit, Michigan, United States, 48201|
|United States, Texas|
|San Antonio, Texas, United States, 78229|