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NCT00496600 · ClinicalTrials.gov registry record · Phase 1
Phase I Study of Patupilone and RAD001
A Phase 1 study, sponsored by University of Medicine and Dentistry of New Jersey.
- Completed
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
NCT00496600: Completed Phase 1 study, sponsored by University of Medicine and Dentistry of New Jersey.
NCT00496600 is a Phase 1 study that has completed, run by University of Medicine and Dentistry of New Jersey. The registered enrollment target is 42 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00496600, a Phase 1 study, has completed, sponsored by University of Medicine and Dentistry of New Jersey.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
Study Summary
This is an unblinded, dose escalation study of patupilone in combination with RAD001 in subjects with advanced cancer to find the maximum tolerated dose of each drug. The purpose of this study is to see what doses of RAD001 and patupilone are safe to use when the two drugs are used at the same time. Other goals in this study are to learn about the effect of RAD 001 and patupilone on tumor growth; to find out what amount of RAD001 is present in the blood when it is combined with patupilone; to learn about proteins in the blood that may predict or show an effect of RAD001 or patupilone and to learn if any changes are seen in the tumor with the type of test called a PET scan.Subjects will be assigned to a dosing group. The dose of patupilone and RAD001 a subject gets depends on when they enter onto this study. The initial subjects in the study will take the lowest doses of RAD001 and patupilone. At least 3 subjects will be treated in each dosing group starting with the smallest dose. If there are few or easy to handle side effects, the next group of at least 3 people to enter in the study will get the next higher dose. This continues until the highest dose of the study drug is found that does not cause serious or hard to treat side effects. Both the subjects and the study doctor will know which dose is assigned. In this study, RAD001 will be given as tablets to take with water. RAD001 will be taken for either 7, 14, or 21 days of each 21 day cycle depending on which dosing group is assigned. If taking RAD 001 and patupilone on the same day, then RAD 001 will be taken with water however prior to receiving patupilone.Patupilone will be given by an intravenous injection (through a vein) for 20 minutes on Days 1 or day 6 of the 21-day cycle. The patupilone dose will be based on height and weight. Blood tests (approximately 1-3 teaspoons) will be done every week. Every six weeks a CT scan or MRI will be done to assess the tumor size. Subjects will continue to receive RAD001
Interventions
- DRUG RAD001
- DRUG Patupilone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2007-07 |
| Est. Completion | 2011-02 |
| Phase | Phase 1 |
What the finished NCT00496600 record still lists
NCT00496600 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower).
The record links to 0 conditions, and to 2 interventions - of which RAD001 is the first listed.
NCT00496600 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00496600 about?
NCT00496600 is a clinical study titled "Phase I Study of Patupilone and RAD001". This is an unblinded, dose escalation study of patupilone in combination with RAD001 in subjects with advanced cancer to find the maximum tolerated dose of each drug. The purpose of this study is to see what doses of RAD001 and patupilone are safe to use when the two drugs are used at the same time....
What is the current status of trial NCT00496600?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2007-07. Estimated completion is 2011-02.
What interventions are being tested in trial NCT00496600?
The interventions under investigation include: RAD001 (DRUG), Patupilone (DRUG).
Who is sponsoring clinical trial NCT00496600?
This trial is sponsored by University of Medicine and Dentistry of New Jersey, which has 88 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00496600's enrollment target sits among peer trials
42 1105th of 2000 higher than 876 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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