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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: Completed Phase 1 study, sponsored by University of California, San Francisco.
NCT01670175 is a Phase 1 study that has completed, run by University of California, San Francisco. The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Define the dose limiting toxicities to recommend a Phase 2 trough concentration of sirolimus when administered on a protracted schedule in combination with oral topotecan and oral cyclophosphamide. Evaluations done during first Cycle to assess/define DLT: Physical exams, vitals, blood tests: CBC, CMB, coagulation-PT, LDH, D-dimer, peripheral smear, urine glucose, performance evaluations. All toxicities observed will be summarized in terms of type (organ affected or laboratory determination),
Interventions
- DRUG Sirolimus, Cyclophosphamide, Topotecan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2012-08 |
| Est. Completion | 2016-09 |
| Phase | Phase 1 |
What the finished NCT01670175 record still lists
NCT01670175 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 1 intervention - of which Sirolimus, Cyclophosphamide, Topotecan is the first listed.
NCT01670175 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01670175's enrollment target sits among peer trials
21 1615th of 2000 higher than 372 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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