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NCT01670175 · ClinicalTrials.gov registry record · Phase 1
Sirolimus With Cyclophosphamide and Topotecan for Pediatric/Adolescent Relapsed and Refractory Solid Tumors
A Phase 1 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT01670175 is a Phase 1 study that has completed, run by University of California, San Francisco. The registered enrollment target is 21 participants.
The verdict
NCT01670175, a Phase 1 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
Study Summary
This is a Phase I study of the combination of three drugs: sirolimus, cyclophosphamide, and topotecan. This is the first study to evaluate the safety and clinical activity of the combination of oral sirolimus, oral cyclophosphamide and oral topotecan in pediatric and young adult patients with relapsed and refractory solid tumors. In this phase I study, the mTOR inhibitor sirolimus will be administered in combination with oral cyclophosphamide and oral topotecan to children with relapsed or refractory solid tumors. The primary aim of this study is to recommend a phase II dose schedule and describe the toxicity of this combination. Myelosuppression will be a targeted toxicity.
Interventions
- DRUG Sirolimus, Cyclophosphamide, Topotecan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2012-08 |
| Est. Completion | 2016-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01670175
The ClinicalTrials.gov registry entry for NCT01670175 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Sirolimus, Cyclophosphamide, Topotecan is the first listed.
NCT01670175 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01670175 about?
NCT01670175 is a clinical study titled "Sirolimus With Cyclophosphamide and Topotecan for Pediatric/Adolescent Relapsed and Refractory Solid Tumors". This is a Phase I study of the combination of three drugs: sirolimus, cyclophosphamide, and topotecan. This is the first study to evaluate the safety and clinical activity of the combination of oral sirolimus, oral cyclophosphamide and oral topotecan in pediatric and young adult patients with relaps...
What is the current status of trial NCT01670175?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2012-08. Estimated completion is 2016-09.
What interventions are being tested in trial NCT01670175?
The interventions under investigation include: Sirolimus, Cyclophosphamide, Topotecan (DRUG).
Who is sponsoring clinical trial NCT01670175?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
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