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NCT00084877 · ClinicalTrials.gov registry record · Phase 1
Irinotecan and 3-AP in Treating Patients With Metastatic or Unresectable Solid Tumors
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT00084877: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00084877 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00084877, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
This phase I trial is studying the side effects and best dose of irinotecan and 3-AP in treating patients with metastatic or unresectable solid tumors. Drugs used in chemotherapy such as irinotecan work in different ways to stop tumor cells from dividing so they stop growing or die. 3-AP may stop the growth of tumor cells by blocking the enzymes necessary for their growth and may help irinotecan kill more tumor cells by making them more sensitive to the drug.
Primary Outcome
Hematologic toxicity measures of thrombocytopenia, neutropenia and leukopenia will be assessed using the continuous variables as the outcome measures (primarily nadir and percent change from baseline values). Nonhematologic toxicities such as diarrhea and stomatitis will be evaluated via the ordinal CTC standard toxicity grading only. Frequency distributions and other descriptive measures will form the basis of the analysis of these variables.
Interventions
- OTHER laboratory biomarker analysis
- OTHER pharmacological study
- DRUG irinotecan hydrochloride
- DRUG triapine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2004-03 |
| Phase | Phase 1 |
What the finished NCT00084877 record still lists
NCT00084877 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 4 interventions - of which laboratory biomarker analysis is the first listed.
NCT00084877 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00084877 about?
NCT00084877 is a clinical study titled "Irinotecan and 3-AP in Treating Patients With Metastatic or Unresectable Solid Tumors". This phase I trial is studying the side effects and best dose of irinotecan and 3-AP in treating patients with metastatic or unresectable solid tumors. Drugs used in chemotherapy such as irinotecan work in different ways to stop tumor cells from dividing so they stop growing or die. 3-AP may stop th...
What is the current status of trial NCT00084877?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2004-03.
What interventions are being tested in trial NCT00084877?
The interventions under investigation include: laboratory biomarker analysis (OTHER), pharmacological study (OTHER), irinotecan hydrochloride (DRUG), triapine (DRUG).
Who is sponsoring clinical trial NCT00084877?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00084877's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 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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