Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27012, United States
NCT Number: NCT01034475
Chemotherapy resistance is a major cause of death in patients with advanced hematologic malignancies. The proposed novel mechanism of action, non-cross resistance with chemotherapeutic agents currently used in the clinic, and lack of CPI-613-related myelosuppression preclinically and clinically to date make CPI-613 a suitable candidate for phase I clinical trial in these patients. The current trial is one of several clinical trials of CPI-613. Other clinical trials that are conducted in patients with solid tumors have already been initiated.
The primary objective of this study is to determine the safety and MTD of CPI-613 when administered 2x weekly for 3 consecutive weeks.
The secondary objective is to determine the PKs of CPI-613 following IV administration and to observe the anti-tumor effects of CPI-613, if any occur.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 1
Winston-Salem, North Carolina, 27012, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This is a Phase I open label trial using a 2-stage dose-escalation scheme (single-patient & traditional stages):
Single-Patient Dose-Escalation Stage: In the single-patient stage, a single patient will be accrued per dose level. The starting dose will be 420 mg/m². Dose level will be escalated (by doubling the previous dose) if there is no toxicity or if the toxicity is grade 1 or less. If toxicity is >Grade 1, the traditional dose-escalation stage will be triggered.
Traditional Dose-Escalation: All dose escalations conducted in this Traditional Dose-Escalation stage will be escalated according to the modified Fibonacci Dose-Escalation scheme.
Time frame: 3 weeks
Time frame: 3 weeks
Wake Forest University Health Sciences
Other
An Open Label, Dose-Escalation 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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT01344707
Advanced Hematologic Malignancies, Blood Protein Disorders
Cologne, Germany
View Trial DetailsNCT00943592
Advanced Hematologic Malignancies, Hematologic Diseases
Chicago, Illinois, United States
View Trial DetailsNCT05088356
Acute Leukemia, Advanced Hematologic Malignancies
Stanford, California, United States
View Trial DetailsNCT07444268
Advanced Hematologic Malignancies
Chapel Hill, North Carolina, United States
View Trial Details