At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 139 enrolled
Drug / intervention
RRx-001 +11 moredrug
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 II Study of RRx-001 in Platinum Refractory/Resistant Small Cell Carcinoma, EGFR TKI Resistant EGFR+ T790M Negative Non-Small Cell Lung Cancer, High Grade Neuroendocrine Tumors and Resistant/Refractory Ovarian Cancer Prior to Re-administration of Platinum Based Doublet Regimens (QUADRUPLE THREAT)
In Brief
A Phase 2 clinical trial evaluating RRx-001, Cisplatin, and 10 other interventions for Small Cell Carcinoma and 3 related conditions. Completed, enrolled 139 participants across 10 sites.
Detailed Summary
This study is designed to explore the potential of the epigenetic agent RRx-001 to sensitize patients who previously received and now have failed a platinum based doublet regimen. RRx-001 is administered with autologous blood once weekly followed by or in combination with reintroduction of platinum-based doublet therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmall Cell Carcinoma, Carcinoma, Non-Small-Cell Lung, Neuroendocrine Tumors, Ovarian Epithelial Cancer
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartJun 2015
First PostedJul 2015
Primary CompletionDec 2021
TodayJul 2026
First PostedJul 3, 2015
Enrollment StartJun 1, 2015
Primary CompletionDec 6, 2021
TodayJul 2, 2026
Enrollment to primary: 6.5 yearsPosted 11.0 years ago
Interventions
RRx-001drug
Cisplatindrug
Etoposidedrug
Carboplatindrug
Irinotecandrug
Vinorelbinedrug
Doxildrug
Gemcitabinedrug
Taxanedrug
Paclitaxeldrug
Nab-Paclitaxeldrug
Pemetrexeddrug