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NCT00586560 · ClinicalTrials.gov registry record · Phase 1
Karenitecin in Pediatric Patients With Refractory or Recurrent Solid Tumors N10010)
A Phase 1 study, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT00586560 is a Phase 1 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 15 participants.
The verdict
NCT00586560, a Phase 1 study, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
This is a Phase 1, open-label, single-center, dose-escalating study in pediatric patients with refractory or recurrent solid tumors. Patients will be registered into 1 of 2 strata, depending upon the presence bone marrow metastases or previous treatment with intensive myelosuppression therapy. Patients will receive Karenitecin along with cyclophosphamide daily for 5 consecutive days, every 21 days (1 treatment cycle). Treatment may continue for up to 20 cycles, as long as there is continued evidence of clinical benefit and an absence of unacceptable toxicity.
Interventions
- DRUG Kareniticin and cyclophosphamide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2007-02 |
| Est. Completion | 2011-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00586560
The ClinicalTrials.gov registry entry for NCT00586560 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Kareniticin and cyclophosphamide is the first listed.
NCT00586560 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00586560 about?
NCT00586560 is a clinical study titled "Karenitecin in Pediatric Patients With Refractory or Recurrent Solid Tumors N10010)". This is a Phase 1, open-label, single-center, dose-escalating study in pediatric patients with refractory or recurrent solid tumors. Patients will be registered into 1 of 2 strata, depending upon the presence bone marrow metastases or previous treatment with intensive myelosuppression therapy. Patie...
What is the current status of trial NCT00586560?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2007-02. Estimated completion is 2011-01.
What interventions are being tested in trial NCT00586560?
The interventions under investigation include: Kareniticin and cyclophosphamide (DRUG).
Who is sponsoring clinical trial NCT00586560?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
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