CPI-613 in Treating Patients With Myelodysplastic Syndromes Who Failed Previous Therapy
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|ClinicalTrials.gov Identifier: NCT01902381|
Recruitment Status : Suspended (Drug sponsor has requested to keep this study open until a new study is initiated. The study is being suspended in the interim time period.)
First Posted : July 18, 2013
Last Update Posted : March 25, 2020
|Condition or disease||Intervention/treatment||Phase|
|Previously Treated Myelodysplastic Syndromes||Drug: 6,8-bis(benzylthio)octanoic acid||Phase 2|
I. To evaluate the safety and anti-cancer activities of CPI-613 in myelodysplastic syndrome (MDS) patients who have failed previous agents (such as decitabine [Dacogen], azacitidine [Vidaza], growth factors or lenalidomide).
Patients receive 6, 8-bis (benzylthio) octanoic acid intravenously (IV) over 2 hours on days 1 and 4 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 5 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of CPI-613 in Patients With Myelodysplastic Syndrome Who Have Failed Previous Therapy|
|Actual Study Start Date :||August 2013|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||May 2020|
Experimental: Treatment (6, 8-bis(benzylthio) octanoic acid)
Patients receive treatment 6,8-bis(benzylthio)octanoic acid IV over 2 hours on days 1 and 4 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Drug: 6,8-bis(benzylthio)octanoic acid
- Response rate (RR), defined as the combined rate of complete remission (CR), marrow CR, partial remission (PR), or stable disease (SD), as described by Cheson, et al. (2006) [ Time Frame: Up to 5 years ]Proportion of RR (along with a 95% confidence interval) of patients who respond will be presented.
- Safety profile of CPI-613, based on evaluation of symptoms, vital signs, ECOG performance status and survival, clinical chemistry, hematology, and coagulation, assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0 [ Time Frame: Up to 1 month post-treatment ]Toxicities will be examined by looking at each toxicity identified by grade.
- Progression-free survival (PFS) [ Time Frame: Up to 5 years ]Survival curves for PFS using Kaplan-Meier techniques will be estimated. In addition, the 6 month and 1-year PFS rates for these participants will be estimated.
- Overall survival (OS) [ Time Frame: Up to 5 years ]Survival curves for OS using Kaplan-Meier techniques will be estimated. In addition, the 6 month and 1-year OS rates for these participants will be estimated.
- Number of patients who achieve a reduction in blood transfusion requirements [ Time Frame: Up to 5 years ]
- Number of patients who achieve hematologic improvement (HI), as defined by Cheson, et al. (2006) [ Time Frame: Up to 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01902381
|United States, North Carolina|
|Comprehensive Cancer Center of Wake Forest University|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Timothy Pardee||Wake Forest University Health Sciences|