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Brief Title: RRx-001 in Lung Cancer, Ovarian Cancer and Neuroendocrine Tumors Prior to Re-administration of Platinum Based Doublet Regimens (QUADRUPLE THREAT)
Official Title: 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)
Study ID: NCT02489903
Brief 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Stanford University, Palo Alto, California, United States
VA Connecticut Cancer Center, West Haven, Connecticut, United States
Memorial Hospital of South Bend, South Bend, Indiana, United States
Baptist Health, Lexington, Kentucky, United States
Walter Reed National Military Medical Center, Bethesda, Maryland, United States
Henry Ford Allegiance Health, Jackson, Michigan, United States
Washington University, Saint Louis, Missouri, United States
University of Cincinnati Cancer Institute, Cincinnati, Ohio, United States
Virginia Cancer Specialists, Fairfax, Virginia, United States
West Virginia University, Morgantown, West Virginia, United States
Name: Bryan Oronsky, MD, PhD
Affiliation: EpicentRx, Inc.
Role: STUDY_DIRECTOR