NCT02489903

RRx-001 in Lung Cancer, Ovarian Cancer and Neuroendocrine Tumors Prior to Re-administration of Platinum Based Doublet Regimens (QUADRUPLE THREAT)

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 139 (actual)
• Sponsor: EpicentRx, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is an open label, four 'cohort' study for administration of RRx-001 with autologous blood once weekly followed by or in combination with reintroduction of platinum-based doublet therapy according to the treatment schedule listed below. Small cell carcinoma and ovarian cohort participants will be randomized to 1 of 2 treatment arms, respectively. Neuroendocrine and NSCLC patients will be enrolled to single arms. Participants with SCC will receive one of the following; RRx-001 followed by platinum doublet chemotherapy or platinum based chemotherapy alone. HGNEC, RRx-001 followed by platinum doublet chemotherapy. NSCLC, RRx-001 followed by platinum doublet chemotherapy. Participants with Platinum Refractory/Resistant Ovarian and MMMT will receive one of the following, RRx-001 followed by platinum doublet chemotherapy or chemotherapy alone. Approximately 213 participants will be enrolled.

Conditions

• Small Cell Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Neuroendocrine Tumors
• Ovarian Epithelial Cancer

Interventions

Type	Name	Description
DRUG	RRx-001
DRUG	Cisplatin
DRUG	Etoposide
DRUG	Carboplatin
DRUG	Irinotecan
DRUG	Vinorelbine
DRUG	Doxil
DRUG	Gemcitabine
DRUG	Taxane
DRUG	Paclitaxel
DRUG	Nab-Paclitaxel
DRUG	Pemetrexed

Timeline

• Start date: 2015-06-01
• Primary completion: 2021-12-06
• Completion: 2021-12-06
• First posted: 2015-07-03
• Last updated: 2025-03-17
• Results posted: 2025-03-17

Locations

10 sites across 1 country: United States