CPI-613

DRUG11 trials

Sponsors

Cornerstone Pharmaceuticals, Wake Forest University Health Sciences, Sidney Kimmel Cancer Center at Thomas Jefferson University, Memorial Sloan Kettering Cancer Center

Conditions

Acute Myeloid Leukemia (AML)Adult Acute Myeloid Leukemia With 11q23 (MLL) AbnormalitiesAdult Acute Myeloid Leukemia With Del(5q)Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)Advanced Cancer

Phase 1

A Open Label Phase I/II Clinical Trial to Evaluate CPI-613 in Patients With Advanced Malignancies

CompletedNCT00741403

Cornerstone PharmaceuticalsAdvanced Cancer, Advanced Malignancies, Lymphoma +2

Start: 2008-08-31End: 2016-12-31Updated: 2016-12-29

A Phase I/II Open-Label Dose-Escalation Clinical Trial of CPI-613 in Combination With Gemcitabine in Cancer Patients

TerminatedNCT00907166

Cornerstone PharmaceuticalsCancer, Pancreatic Cancer, Pancreatic Carcinoma

Start: 2009-05-31End: 2017-12-31Updated: 2017-03-21

Study to Evaluate Safety, Tolerability, Maximum Tolerated Dose (MTD), Efficacy, and Pharmacokinetics (PKs) of CPI-613 Given Twice Weekly for Three Consecutive Weeks in Patients With Advanced Hematologic Malignancies

CompletedNCT01034475

Wake Forest University Health SciencesAdvanced Hematologic Malignancies

Start: 2010-03-31End: 2014-08-31Updated: 2018-07-02

CPI-613, Cytarabine, and Mitoxantrone Hydrochloride in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

CompletedNCT01768897

Wake Forest University Health SciencesAdult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) +4

Start: 2013-01-31End: 2016-01-31Updated: 2018-07-03

CPI-613 and Hydroxychloroquine for Patients With High Risk Myelodysplastic Syndrome

WithdrawnNCT03929211

Wake Forest University Health SciencesMyelodysplastic Syndromes, Progressive Disease

Start: 2021-05-31End: 2027-07-31Updated: 2021-04-14

CPI-613 (Devimistat) in Combination With Modified FOLFIRINOX Plus Bevacizumab in Patients With Metastatic Colorectal Cancer

WithdrawnNCT05070104

Cornerstone PharmaceuticalsC04.588.274.476.411.307

Start: 2023-03-30End: 2024-11-01Updated: 2023-09-13

Phase 2

Safety and Effectiveness Study of CPI-613 to Treat Refractory or Relapsed Leukemia and Myelodysplastic Syndrome

WithdrawnNCT01520805

Cornerstone PharmaceuticalsAcute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS)

Start: 2016-01-31End: 2018-12-31Updated: 2016-12-29

Safety and Effectiveness Study of CPI-613 and/or Gemcitabine to Treat Metastatic Pancreatic Cancer

WithdrawnNCT01830322

Cornerstone PharmaceuticalsMetastatic Pancreatic Adenocarcinoma

Start: 2014-01-31End: 2018-12-31Updated: 2013-08-14

Phase 2 Safety, Tolerability and Efficacy Study of CPI-613 in Cancer Patients

TerminatedNCT01832857

Cornerstone PharmaceuticalsCancer

Start: 2013-06-30End: 2016-12-31Updated: 2016-12-29

CPI-613 in Combination With Modified FOLFIRINOX in Patients With Locally Advanced Pancreatic Cancer

WithdrawnNCT03374852

Sidney Kimmel Cancer Center at Thomas Jefferson UniversityPancreatic Ductal Adenocarcinoma

Start: 2018-08-31End: 2020-10-31Updated: 2025-04-29

A Study of CPI-613 for Patients With Relapsed or Refractory Burkitt Lymphoma/Leukemia or High-Grade B-Cell Lymphoma With High-Risk Translocations

CompletedNCT03793140

Memorial Sloan Kettering Cancer CenterLeukemia, Lymphoma

Start: 2018-12-31End: 2026-08-25Updated: 2026-08-27

Related Papers

Novel devimistat results in complete remissions in heavily pretreated Burkitt lymphoma in a phase 2 trial.

2025-11-01

Devimistat Results in a Low Complete Remission Rate in Heavily Pre-Treated Burkitt Lymphoma

Blood2024-11-05

Repurposing the FDA-approved anthelmintic pyrvinium pamoate for pancreatic cancer treatment: study protocol for a phase I clinical trial in early-stage pancreatic ductal adenocarcinoma

BMJ Open2023-10-0111 citations

Complete Remission with Devimistat (CPI-613) in Refractory Burkitt Lymphoma

Blood2021-11-055 citations

PRELIMINARY ACTIVITY OF DEVIMISTAT (CPI 613) IN PATIENTS WITH RELAPSED OR REFRACTORY BURKITT LYMPHOMA/LEUKEMIA

Hematological Oncology2021-06-01

A Phase II Clinical Trial of Cpi-613 (devimistat) in Patients with Relapsed or Refractory Burkitt Lymphoma/Leukemia or High-Grade B-Cell Lymphoma with Rearrangements of MYC and BCL2and/or BCL6

Blood2019-11-136 citations

Activity of the mitochondrial metabolism inhibitor cpi-613 in combination with high dose Ara-C (HDAC) and mitoxantrone in high risk relapsed or refractory acute myeloid leukemia (AML).

Journal of Clinical Oncology2015-05-204 citations

A phase I study of the mitochondrial metabolism inhibitor CPI-613 in combination with high-dose ara-C (HDAC) and mitoxantrone for relapsed or refractory acute myeloid leukemia (AML).

Journal of Clinical Oncology2014-05-201 citations