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Metabolic Inhibitor

CPI-613 + Hydroxychloroquine for Clear Cell Sarcoma

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

Study Summary

This trial will test a new combination of drugs to treat patients with a certain type of cancer that has returned or does not respond to other treatments. The goal is to find the best dose of the new combination and to see if it is effective and safe.

Eligible Conditions
  • Clear Cell Sarcoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
MTD (Phase I)
ORR (Overall Response rate): CR +PR (Phase II)
Toxicity (Phase I)
Secondary outcome measures
DOR (Duration of Response)
OS (Overall Survival)
PFS (Progression Free Survival)

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
13 Previous Clinical Trials
845 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there other instances of using CPI-613 in conjunction with Hydroxychloroquine?

"CPI-613 in conjunction with Hydroxychloroquine was first studied 13 years ago at University of Nebraska Medical Center. There have been a total of 140 completed clinical trials as of now. Additionally, there are 72 active clinical trials taking place, a majority of which are based in Seattle, Washington."

Answered by AI

Are people still being asked to participate in this experiment?

"Yes, the trial is still open for recruitment according to information on clinicaltrials.gov. This specific study was posted on September 1st, 2021 and updated November 10th, 2022. They are currently looking for 59 patients total from 8 different medical sites."

Answered by AI

How does one qualify for participation in this experiment?

"This clinical trial is testing a new medication for patients with clear cell sarcoma. To qualify, applicants must be between 2 and 100 years old. So far, 59 people have been accepted into the study."

Answered by AI

What are the primary conditions that doctors attempt to alleviate with CPI-613 + Hydroxychloroquine?

"Many patients suffering from malaria have found relief through CPI-613 + Hydroxychloroquine. This treatment method is also effective for q fever, rheumatoid arthritis, and sjögren's syndrome."

Answered by AI

Are people of all ages welcome in this particular research project?

"The age range for this particular trial is 2 to 100. There are a total of 167 studies involving patients that are younger and 441 trials with senior citizens."

Answered by AI

Does this study have a broad geographical scope in North America?

"Presently, 8 medical facilities are recruiting patients for this study. The sites are based in Seattle, Winston-Salem, Portland as well as 5 additional places. To limit travel if you take part in this trial, choose the location that is most proximate to where you live."

Answered by AI

What is the highest number of people who can join this research project?

"59 patients that fit the bill are necessary to carry out this study. It will be conducted by Rafael Pharmaceuticals Inc. at various hospitals, such as Seattle Children's Hospital in Seattle, Washington and Atrium Health Wake Forest Baptist in Winston-Salem, North carolina."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
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
2021. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04593758.
~4 spots leftby Apr 2025
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