At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 127 enrolled
Drug / intervention
RX-3117drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1, Open-Label, Dose-Ranging, Safety and Pharmacokinetic Study to Determine the Maximum Tolerated Dose of RX-3117 Administered Orally as a Single-Agent to Subjects With Advanced Malignancies
In Brief
A Phase 2 clinical trial evaluating RX-3117 for Solid Tumor and Metastatic Bladder Cancer. Completed, enrolled 127 participants across 12 sites.
Detailed Summary
The purpose of this study is to determine the maximum tolerated dose of RX-3117 in subjects with advanced or metastatic solid tumors (Phase 1). The purpose of the Phase 2 portion is to estimate anti-tumor activity in subjects with advanced malignancies (relapsed or refractory pancreatic or advanced bladder cancer).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Tumor, Metastatic Bladder Cancer
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartDec 2013
First PostedJan 2014
Primary CompletionJul 2019
Study CompletionDec 2019
TodayJul 2026
First PostedJan 8, 2014
Enrollment StartDec 1, 2013
Primary CompletionJul 1, 2019
Study CompletionDec 1, 2019
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 12.5 years ago
Interventions
RX-3117drug