At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 26 enrolled
Drug / intervention
RRx-001 +5 moredrug
Likely dose
RRx-001 10 mg/m2from 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 I, Open-Label, Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of RRx-001 in Subjects With Advanced Solid Tumors or Lymphomas For Which There Are No Currently Accepted Curative Therapies
In Brief
A Phase 1 clinical trial evaluating RRx-001 for Malignant Solid Tumor and Lymphomas. Completed, enrolled 26 participants across 2 sites.
Detailed Summary
The purpose of this study is to evaluate the safety and pharmacokinetic profile of RRx-001 for injection in subjects with advanced solid tumors or lymphomas for which there are no currently accepted curative therapies. This study will also conduct an exploratory evaluation of objective tumor response using CT or MRI.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalignant Solid Tumor, Lymphomas
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 2011
Enrollment StartSep 2011
Primary CompletionFeb 2015
TodayJul 2026
First PostedMay 25, 2011
Enrollment StartSep 1, 2011
Primary CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 15.1 years ago
Interventions
RRx-001drug
Dose level 1 (10 mg/m2)
RRx-001drug
Dose Level 2 (16.7 mg/m2)
RRx-001drug
Dose Level 3 (24.6 mg/m2)
RRx-001drug
Dose Level 4 (33 mg/m2)
RRx-001drug
Dose Level 5 (55.0 mg/m2)
RRx-001drug
Dose Level 6 (83 mg/m2)