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NCT00953576 · ClinicalTrials.gov registry record · Phase 1
Ketoconazole, Hydrocortisone, Dutasteride and Lapatinib (KHAD-L) in Prostate Cancer
A Phase 1 study, sponsored by Dana-Farber Cancer Institute.
- Terminated
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
NCT00953576: Clinical Trial Phase 1 study, sponsored by Dana-Farber Cancer Institute.
NCT00953576 is a Phase 1 study that was terminated before completion, run by Dana-Farber Cancer Institute. The registered enrollment target is 11 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00953576, a Phase 1 study, was terminated before completion, sponsored by Dana-Farber Cancer Institute.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
The purpose of this research study is to determine the safety of giving ketoconazole, hydrocortisone and dutasteride (KHAD) with lapatinib. Safety is primarily based on dose limiting toxicity (DLT) evaluation at various dose levels (DL). The investigators believe that there is evidence in castrate resistant prostate cancer (CRPC) that two growth factor receptors (EGFR and Her 2/Neu) are increased in prostate cancer (PCa) cells. Both these receptors are turned off by the drug lapatinib. By adding lapatinib, the investigators hope that signaling from the receptors will be turned off and therefore make the participant's cancer more responsive to KHAD treatment.
Primary Outcome
The MTD of lapatinib in combination with KHAD is determined by the number of participants who experience a dose limiting toxicity (DLT) at the various dose levels of lapatinib under evaluation. See subsequent primary outcome measure for the DLT definition. The MTD is defined as the lapatinib dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed, the MTD is not reached and the Recommended Phase II Dose (RP2D) will be based on safety and pharmacokinetic results.
Interventions
- DRUG dutasteride
- DRUG ketoconazole
- DRUG lapatinib
- DRUG hydrocortisone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2009-09-29 |
| Est. Completion | 2013-04-11 |
| Phase | Phase 1 |
Why NCT00953576 stopped before completion
NCT00953576 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 4 interventions - of which dutasteride is the first listed.
NCT00953576 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00953576 about?
NCT00953576 is a clinical study titled "Ketoconazole, Hydrocortisone, Dutasteride and Lapatinib (KHAD-L) in Prostate Cancer". The purpose of this research study is to determine the safety of giving ketoconazole, hydrocortisone and dutasteride (KHAD) with lapatinib. Safety is primarily based on dose limiting toxicity (DLT) evaluation at various dose levels (DL). The investigators believe that there is evidence in castrate r...
What is the current status of trial NCT00953576?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2009-09-29. Estimated completion is 2013-04-11.
What interventions are being tested in trial NCT00953576?
The interventions under investigation include: dutasteride (DRUG), ketoconazole (DRUG), lapatinib (DRUG), hydrocortisone (DRUG).
Who is sponsoring clinical trial NCT00953576?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00953576's enrollment target sits among peer trials
11 1911th of 2000 higher than 88 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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