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Alkylating agents
Cisplatin/carboplatin plus etoposide for Small Cell Lung Cancer (REPLATINUM Trial)
Phase 3
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 estimated up to 12 months
Awards & highlights
REPLATINUM Trial Summary
This trial is testing a new treatment for small cell cancer that has gotten worse despite other treatments. The new treatment is a combination of a drug called RRx-001 with standard platinum-based chemotherapy.
Eligible Conditions
- Small Cell Lung Cancer
REPLATINUM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ estimated up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~estimated up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression Free Survival
Secondary outcome measures
Overall Survival
Overall response rate
REPLATINUM Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 1Experimental Treatment2 Interventions
RRx-001 + eLOOP Device 4 mg IV infusion once weekly for 3 weeks
Cisplatin/carboplatin plus etoposide (up to 4 cycles):
Cisplatin or Carboplatin:
Cisplatin initially dosed at 60 mg/m2 on Day 1 every 3 weeks OR
Carboplatin initially dosed at an AUC (area under the curve) of 5 on Day 1 every 3 weeks
Etoposide to be given per the initial approval by the package insert (USPI FDA) at 100 mg/m2 Days 1-3 every 3 weeks
Group II: Arm 2Active Control1 Intervention
Cisplatin/carboplatin plus etoposide (up to 4 cycles):
Cisplatin or Carboplatin:
Cisplatin initially dosed at 60 mg/m2 on Day 1 every 3 weeks OR
Carboplatin initially dosed at an AUC of 5 on Day 1 every 3 weeks
Etoposide to be given per the initial approval by the package insert (USPI FDA) at 100 mg/m2 Days 1-3 every 3 weeks
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Who is running the clinical trial?
EpicentRx, Inc.Lead Sponsor
15 Previous Clinical Trials
1,036 Total Patients Enrolled
Bryan Oronsky, MD, PhDStudy DirectorEpicentRx, Inc.
2 Previous Clinical Trials
187 Total Patients Enrolled
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