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NCT00195260 · ClinicalTrials.gov registry record · Phase 1
Study Evaluating SKI-606 (Bosutinib) In Advanced Malignant Solid Tumors
A Phase 1 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 151
- Enrollment target
NCT00195260: Completed Phase 1 study, sponsored by Pfizer.
NCT00195260 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 151 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (152% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00195260, a Phase 1 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 151 participants
- Enrollment target
Study Summary
To evaluate the safety and tolerability of oral SKI-606 (bosutinib) administered on a daily schedule to subjects with advanced malignant solid tumors and to define a maximum tolerated dose (MTD) in this subject population.
Primary Outcome
DLT included any grade 3 or 4 clinically-evident non-hematologic toxicity, grade 4 neutropenia of greater than or equal to (\>=) 7-day duration or with fever \>= 38.5 degrees Celsius (febrile neutropenia); grade 4 thrombocytopenia \>= 2-day duration or with bleeding requiring platelet transfusion, any clinically-significant grade \>= 2 toxicity that requires \>=14 days to resolve (to less than or equal to \[=\<\] grade 1) which occurred in first 21 days of study and considered at least possibly
Interventions
- DRUG bosutinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 151 participants |
| Start Date | 2004-10 |
| Est. Completion | 2007-11 |
| Phase | Phase 1 |
What the finished NCT00195260 record still lists
NCT00195260 is an interventional study that assigns participants to a tested intervention. The registered 151 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (152% higher).
The record links to 0 conditions, and to 1 intervention - of which bosutinib is the first listed.
NCT00195260 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00195260 about?
NCT00195260 is a clinical study titled "Study Evaluating SKI-606 (Bosutinib) In Advanced Malignant Solid Tumors". To evaluate the safety and tolerability of oral SKI-606 (bosutinib) administered on a daily schedule to subjects with advanced malignant solid tumors and to define a maximum tolerated dose (MTD) in this subject population.
What is the current status of trial NCT00195260?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 151 participants. The study started on 2004-10. Estimated completion is 2007-11.
What interventions are being tested in trial NCT00195260?
The interventions under investigation include: bosutinib (DRUG).
Who is sponsoring clinical trial NCT00195260?
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 NCT00195260's enrollment target sits among peer trials
151 363rd of 2000 higher than 1,638 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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