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Epigenetic Agent
RRx-001 in Lung Cancer, Ovarian Cancer and Neuroendocrine Tumors Prior to Re-administration of Platinum Based Doublet Regimens (QUADRUPLE THREAT)
Phase 2
Waitlist Available
Research Sponsored by EpicentRx, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to one year
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new drug, RRx-001, given with the patient's own blood and followed by standard chemotherapy. It targets patients with certain cancers who did not respond to previous treatments. The drug works by making cancer cells more sensitive to chemotherapy.
Eligible Conditions
- Neuroendocrine Tumors
- Small Cell Carcinoma
- Cancer
- Ovarian Cancer
- Non-Small Cell Lung Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to one year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall Survival
Secondary study objectives
Disease Control Rate (DCR)
Overall Response Rate (ORR)
Progression Free Survival (PFS)
Side effects data
From 2020 Phase 2 trial • 62 Patients • NCT0209635442%
Fatigue
34%
Infusion related reaction
32%
Diarrhea
24%
Vomiting
24%
Abdominal pain
18%
Disease progression
18%
Back Pain
16%
Hypertension
16%
Insomnia
16%
Constipation
16%
Urinary tract infection
13%
Tachycardia
11%
Hyponatraemia
11%
Small intestinal obstruction
11%
Metastases to liver
11%
Hypokalaemia
11%
Anxiety
8%
Dyspnoea
8%
Anemia
8%
Tumour pseudoprogression
5%
Hypercoagulability
5%
Malignant pleural effusion
5%
Pneumonia
5%
Enterovesical fistula
5%
Liver function test abnormal
5%
Depression
5%
Night sweats
5%
Ascites
5%
Rectal haemorrhage
5%
Infection
5%
Pleural effusion
3%
Acute kidney injury
3%
Spinal fracture
3%
Hepatic encephalopathy
3%
Hyperglycemia
3%
Nausea
3%
Hydrocephalus
3%
Delirium
3%
Mental status changes
3%
Anaemia
3%
Iron deficiency anaemia
3%
Acute Renal Failure
3%
Intestinal obstruction
3%
Myocardial infarction
3%
Dehydration
3%
Systemic inflammatory response syndrome
3%
Biliary sepsis
3%
Influenza
3%
Acute hepatic failure
3%
Bronchial Obstruction
3%
Bacteraemia
3%
Arthralgia
100%
80%
60%
40%
20%
0%
Study treatment Arm
RRx-001 Followed by Irinotecan
Regorafenib Followed by Irinotecan
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
6Treatment groups
Experimental Treatment
Active Control
Group I: Small Cell Lung Cancer (Arm 1)Experimental Treatment4 Interventions
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).
Group II: Ovarian epithelial cancer (Arm 1)Experimental Treatment2 Interventions
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).
Group III: Non Small Cell Lung CancerExperimental Treatment6 Interventions
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).
Group IV: Neuroendocrine tumorsExperimental Treatment4 Interventions
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).
Group V: Ovarian epithelial cancer (Arm 2)Active Control6 Interventions
Carboplatin, Etoposide, Doxil, Gemcitabine or Vinorelbine or Taxane until progression or intolerable toxicity
Group VI: Small Cell Lung Cancer (Arm 2)Active Control5 Interventions
Carboplatin or cisplatin plus etoposide or irinotecan or vinorelbine until progression or intolerable toxicity
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etoposide
2010
Completed Phase 3
~2960
Carboplatin
2014
Completed Phase 3
~6120
Paclitaxel
2011
Completed Phase 4
~5450
Nab-Paclitaxel
2014
Completed Phase 3
~4540
Pemetrexed
2014
Completed Phase 3
~5550
Cisplatin
2013
Completed Phase 3
~3120
RRx-001
2015
Completed Phase 2
~300
Find a Location
Who is running the clinical trial?
EpicentRx, Inc.Lead Sponsor
15 Previous Clinical Trials
903 Total Patients Enrolled
Bryan Oronsky, MD, PhDStudy DirectorEpicentRx, Inc.
2 Previous Clinical Trials
71 Total Patients Enrolled