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NCT00940498 · ClinicalTrials.gov registry record · Phase 1
Study of PF-05212384 (Also Known as PKI-587)Administered Intravenously To Subjects With Solid Tumors
A Phase 1 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 78
- Enrollment target
NCT00940498: Completed Phase 1 study, sponsored by Pfizer.
NCT00940498 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 78 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00940498, a Phase 1 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 78 participants
- Enrollment target
Study Summary
This is a two-part study of a compound called PF-05212384 (also known as PKI-587). The purpose of part 1 is to identify the Maximum Tolerated Dose (MTD) of PF-05212384 using a Continual Reassessment Method (CRM). Part 1 will include subjects with any solid tumor. In Part 2 two cohorts will be enrolled. One cohort will assess safety, tolerability and preliminary efficacy in 20 subjects at the MTD and will include subjects with breast cancer, ovarian cancer, endometrial cancer, colorectal cancer renal cancer or glioblastoma (a type of brain tumor). The other cohort will include 5 to 15 subjects with any type of tumor who consent to provide tumor biopsies while participating in the study.
Primary Outcome
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Cycle
Interventions
- DRUG PF-05212384 (also known as PKI-587)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2010-01 |
| Est. Completion | 2012-10 |
| Phase | Phase 1 |
What the finished NCT00940498 record still lists
NCT00940498 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% higher).
The record links to 0 conditions, and to 1 intervention - of which PF-05212384 (also known as PKI-587) is the first listed.
NCT00940498 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00940498 about?
NCT00940498 is a clinical study titled "Study of PF-05212384 (Also Known as PKI-587)Administered Intravenously To Subjects With Solid Tumors". This is a two-part study of a compound called PF-05212384 (also known as PKI-587). The purpose of part 1 is to identify the Maximum Tolerated Dose (MTD) of PF-05212384 using a Continual Reassessment Method (CRM). Part 1 will include subjects with any solid tumor. In Part 2 two cohorts will be enroll...
What is the current status of trial NCT00940498?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 78 participants. The study started on 2010-01. Estimated completion is 2012-10.
What interventions are being tested in trial NCT00940498?
The interventions under investigation include: PF-05212384 (also known as PKI-587) (DRUG).
Who is sponsoring clinical trial NCT00940498?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00940498's enrollment target sits among peer trials
78 697th of 2000 higher than 1,298 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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