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NCT01393509 · ClinicalTrials.gov registry record · Phase 1
The First-in-human Phase I Trial of PU-H71 in Patients With Advanced Malignancies
A Phase 1 study, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 47
- Enrollment target
NCT01393509: Completed Phase 1 study, sponsored by Memorial Sloan Kettering Cancer Center.
NCT01393509 is a Phase 1 study that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 47 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01393509, a Phase 1 study, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 47 participants
- Enrollment target
Study Summary
NOTE: This study is now recruiting only patients with Myeloproliferative Neoplasms (MPN). Dose escalation has been completed. The purpose of this study is to test a new drug, called PU-H71 for the first time in humans, to find out what effects, good or bad, this new drug has on the patient and the cancer at different dose levels. PU-H71 blocks a protein called Heat Shock Protein-90 (Hsp90). Hsp90 is found in both normal and cancer cells, but may be more important in cancer cells. Attacking Hsp90 can stop the function of certain proteins that are needed for cancer cells to survive. The diseases that are part of this study may be especially sensitive to attacking Hsp90, and the investigators have seen signs of disease control in patients with MPN. This study is currently enrolling a cohort expansion for patients with myeloproliferative neoplasms (MPN).
Primary Outcome
Toxicity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. All patients enrolled who receive study drug will be eligible for these analyses.
Interventions
- DRUG PU-H71
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2011-07-06 |
| Est. Completion | 2023-03-23 |
| Phase | Phase 1 |
What the finished NCT01393509 record still lists
NCT01393509 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% lower).
The record links to 0 conditions, and to 1 intervention - of which PU-H71 is the first listed.
NCT01393509 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01393509 about?
NCT01393509 is a clinical study titled "The First-in-human Phase I Trial of PU-H71 in Patients With Advanced Malignancies". NOTE: This study is now recruiting only patients with Myeloproliferative Neoplasms (MPN). Dose escalation has been completed. The purpose of this study is to test a new drug, called PU-H71 for the first time in humans, to find out what effects, good or bad, this new drug has on the patient and the ...
What is the current status of trial NCT01393509?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 47 participants. The study started on 2011-07-06. Estimated completion is 2023-03-23.
What interventions are being tested in trial NCT01393509?
The interventions under investigation include: PU-H71 (DRUG).
Who is sponsoring clinical trial NCT01393509?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01393509's enrollment target sits among peer trials
47 1053rd of 2000 higher than 943 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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