RRx-001 in Lung Cancer, Ovarian Cancer and Neuroendocrine Tumors Prior to Re-administration of Platinum Based Doublet Regimens (QUADRUPLE THREAT)
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|ClinicalTrials.gov Identifier: NCT02489903|
Recruitment Status : Recruiting
First Posted : July 3, 2015
Last Update Posted : November 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Small Cell Carcinoma Carcinoma, Non-Small-Cell Lung Neuroendocrine Tumors Ovarian Epithelial Cancer||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||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||213 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||June 2015|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||June 2021|
Experimental: Small Cell Lung Cancer (Arm 1)
RRx-001 weekly for 3 weeks followed by up to 4 cycles of carboplatin or cisplatin plus etoposide and then RRx-001 and carboplatin or cisplatin (for patients with stable disease (SD) or better at discontinuation of platinum).
Active Comparator: Small Cell Lung Cancer (Arm 2)
Carboplatin or cisplatin plus etoposide or irinotecan or vinorelbine until progression or intolerable toxicity
Experimental: Non Small Cell Lung Cancer
RRx-001 weekly for 3 weeks followed by up to 6 cycles of cisplatin or carboplatin plus paclitaxel or nab-paclitaxel or pemetrexed and then RRx-001 maintenance (for patients with stable disease or better at discontinuation of platinum).
Experimental: Neuroendocrine tumors
RRx-001 weekly until progression followed by up to 6 cycles of carboplatin or cisplatin plus etoposide and then RRx-001 maintenance (for patients with stable disease or better at discontinuation of platinum).
Experimental: Ovarian epithelial cancer (Arm 1)
RRx-001 weekly for 2 weeks followed by 2 cycles of Carboplatin chemotherapy and then RRx-001/Carboplatin maintenance (for patients with stable disease or better at discontinuation of platinum).
Active Comparator: Ovarian epithelial cancer (Arm 2)
Carboplatin, Etoposide, Doxil, Gemcitabine or Vinorelbine or Taxane until progression or intolerable toxicity
- Overall Survival [ Time Frame: up to one year ]the time from enrollment until the time of death from any cause or last follow-up. Patients will be followed clinically as outlined in the treatment schedule and will be followed off study for death.
- Overall Response Rate (ORR) [ Time Frame: 12 weeks ]
The proportion of patients who achieve a reduction in the sum of target lesions by 30% following the re-administration of chemotherapy.
Radiographic assessment of disease burden will be evaluated by CT and disease RR will be documented using RECIST v1.1.
- Disease Control Rate (DCR) [ Time Frame: 12weeks ]The percentage of patients who have achieved complete response, partial response and stable disease (as per RECIST v1.1).
- Progression Free Survival (PFS) [ Time Frame: 12 weeks ]the time from enrollment to the time of the first radiographic documentation of objective progression as defined by RECIST v1.1 or death from any cause.
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability of platinum doublet therapy post RRx-001 [ Time Frame: 12 weeks ]
- Changes in the level of serum biomarkers will be calculated and treatment samples will be compared to baseline samples using one-sample tests (e.g., paired t test or Wilcoxon signed rank test). [ Time Frame: 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02489903
|Contact: Scott Caroenfirstname.lastname@example.org|
|United States, California|
|Palo Alto, California, United States, 94304|
|Contact: Melanie San Pedro-Salcedo 650-724-1388 email@example.com|
|Principal Investigator: Sukhmani Padda, MD|
|United States, Connecticut|
|VA Connecticut Cancer Center||Recruiting|
|West Haven, Connecticut, United States, 06516|
|Contact: Jessica Jordan 203-932-5711 ext 3287 firstname.lastname@example.org|
|Principal Investigator: Michal Rose, MD|
|United States, Indiana|
|Memorial Hospital of South Bend||Recruiting|
|South Bend, Indiana, United States, 46601|
|Contact: Amie Lake 574-647-6784 ALake@beaconhealthsystem.org|
|Contact: Mary Jane Danner 574-647-7309 MDanner@beaconhealthsystem.org|
|Principal Investigator: Thomas J Reid, MD, PhD|
|United States, Kentucky|
|Lexington, Kentucky, United States, 40503|
|Contact: Stephanie Cason 859-260-3197 email@example.com|
|Contact: Micheal F Stephens 859-260-6456 micheal.stephens@BHSI.com|
|Principal Investigator: Arvinda Padmanabhan, MD|
|United States, Maryland|
|Walter Reed National Military Medical Center||Recruiting|
|Bethesda, Maryland, United States, 20889|
|Contact: Sonja Skeete 301-319-4599 firstname.lastname@example.org|
|Principal Investigator: Karen Zeman, MD|
|United States, Michigan|
|Henry Ford Allegiance Health||Recruiting|
|Jackson, Michigan, United States, 49201|
|Contact: Kris Strzalkowski, RN 517-205-1522 KSTRZAL1@hfhs.org|
|Contact: Natalie Peterson, RN OCN (517) 205-1549 email@example.com|
|Principal Investigator: Malcolm Trimble, MD|
|United States, Missouri|
|Saint Louis, Missouri, United States, 63110|
|Contact: Dan Blume 314-362-0872 firstname.lastname@example.org|
|Principal Investigator: Daniel Morgensztern, MD|
|United States, Ohio|
|University of Cincinnati Cancer Institute||Recruiting|
|Cincinnati, Ohio, United States, 45267|
|Contact: Lauren Hendricks 513-584-5725 email@example.com|
|Principal Investigator: John C Morris, MD|
|United States, Tennessee|
|University of Tennessee Medical Center||Withdrawn|
|Knoxville, Tennessee, United States, 37920|
|United States, Virginia|
|Virginia Cancer Specialists||Recruiting|
|Fairfax, Virginia, United States, 22031|
|Contact: Karin Choquette, MSN, RN 703-208-9268 Karin.Choquette@USONCOLOGY.COM|
|Principal Investigator: Alexander Spira, MD|
|United States, West Virginia|
|West Virginia University||Recruiting|
|Morgantown, West Virginia, United States, 26506|
|Contact: Carla Ross, RN 304-581-1158 firstname.lastname@example.org|
|Principal Investigator: Patrick Ma, MD|
|Study Director:||Bryan Oronsky, MD, PhD||EpicentRx, Inc.|