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Metabolic Inhibitor
To Evaluate Maximally Tolerated Dose (MTD), Safety and Efficacy of CPI-613® (Devimistat) Plus Hydroxychloroquine in Patients With Relapsed or Refractory Clear Cell Sarcoma of Soft Tissue
Phase 1 & 2
Waitlist Available
Research Sponsored by Rafael Pharmaceuticals Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a combination of two drugs, hydroxychloroquine and devimistat, in patients whose Clear Cell Sarcoma of the Soft Tissue has returned or did not respond to previous treatments. Hydroxychloroquine helps make cancer cells more sensitive, while devimistat cuts off their energy supply. The goal is to find the best dose and see how well this combination works.
Eligible Conditions
- Clear Cell Sarcoma
- Clear Cell Sarcoma of Soft Tissue
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
MTD (Phase I)
ORR (Overall Response rate): CR +PR (Phase II)
Toxicity (Phase I)
Secondary study objectives
DOR (Duration of Response)
OS (Overall Survival)
PFS (Progression Free Survival)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: CPI-613 + HydroxychloroquineExperimental Treatment1 Intervention
dosing regimen was 600mg hydroxychloroquine PO followed 2 hours later by 2,000 mg/m2 of CPI-613 by central IV infusion over 2 hours followed by 600 mg hydroxychloroquine PO 12 hours following the initial dose daily on days 1 through 5 of every 28 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CPI-613 + Hydroxychloroquine
2021
Completed Phase 2
~20
Find a Location
Who is running the clinical trial?
Rafael Pharmaceuticals Inc.Lead Sponsor
8 Previous Clinical Trials
780 Total Patients Enrolled
Cornerstone PharmaceuticalsLead Sponsor
14 Previous Clinical Trials
828 Total Patients Enrolled