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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

September 1, 2021

Primary Completion Date

March 9, 2023

Study Completion Date

March 9, 2023

Conditions
Sarcoma, Clear Cell
Interventions
DRUG

CPI-613 + Hydroxychloroquine

"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.~Starting dose of 80% of the maximum tolerated (MTD) identified in patients ≥ 45 kg for patients \< 45 kg"

Trial Locations (8)

27109

Atrium Health Wake Forest Baptist, Winston-Salem

37232

Vanderbilt University Medical Centrer, Nashville

44195

Clevland Clinic, Ohio City

48109

University of Michigan, Ann Arbor

66160

University of Kansas Medical Center, Kansas City

91010

City of Hope, Duarte

97239

Oregon Health and Science University, Portland

98105

Seattle Children's Hospital, Seattle

Sponsors
All Listed Sponsors
lead

Cornerstone Pharmaceuticals

INDUSTRY

NCT04593758 - 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 | Biotech Hunter | Biotech Hunter