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NCT01034475 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT01034475 is a Phase 1 study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 26 participants.
The verdict
NCT01034475, a Phase 1 study, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG CPI-613
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2010-03 |
| Est. Completion | 2014-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01034475
The ClinicalTrials.gov registry entry for NCT01034475 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which CPI-613 is the first listed.
NCT01034475 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01034475 about?
NCT01034475 is a clinical study titled "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". 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 d...
What is the current status of trial NCT01034475?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2010-03. Estimated completion is 2014-08.
What interventions are being tested in trial NCT01034475?
The interventions under investigation include: CPI-613 (DRUG).
Who is sponsoring clinical trial NCT01034475?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
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