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NCT03099356 · ClinicalTrials.gov registry record · Phase 2
Cyclophosphamide and Sirolimus for the Treatment of Metastatic, RAI-refractory, Differentiated Thyroid Cancer
A Phase 2 study of Metastatic Thyroid Cancer, sponsored by University of Michigan Rogel Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
- 1
- Study location
NCT03099356: Recruiting Phase 2 study of Metastatic Thyroid Cancer, sponsored by University of Michigan Rogel Cancer Center.
NCT03099356 is a Phase 2 study of Metastatic Thyroid Cancer that is actively recruiting participants, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 22 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03099356, a Phase 2 study of Metastatic Thyroid Cancer, is actively recruiting participants, sponsored by University of Michigan Rogel Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will be a non-randomized pilot trial using Cyclophosphamide and Sirolimus for the treatment of metastatic differentiated thyroid cancer. Patients will be treated with Sirolimus 4 mg, PO, days 1-28 as well as Cyclophosphamide 100 mg, PO, days 1-5 and 15-19. Cycle length will be 28 days. Patients will be monitored closely for toxicity and undergo imaging to evaluate efficacy once every 2 cycles.
Primary Outcome
The primary measure of efficacy will be the overall response rate (ORR) which is defined as those achieving either complete response (CR) or partial response (PR). Partial response is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Complete response is defined as Disappearance of all target lesions, determined by two separate observations conducted not less than 4 weeks apart (there can be no appearance of new lesions) and the disappearance of all no
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Sirolimus
Study Locations (1)
Michigan
- University of Michigan Cancer Center - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2017-04-27 |
| Est. Completion | 2026-12 |
| Phase | Phase 2 |
What NCT03099356 shows while recruiting
NCT03099356 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Metastatic Thyroid Cancer appearing as the primary indexed condition, and to 2 interventions - of which Cyclophosphamide is the first listed.
NCT03099356 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT03099356 about?
NCT03099356 is a clinical study titled "Cyclophosphamide and Sirolimus for the Treatment of Metastatic, RAI-refractory, Differentiated Thyroid Cancer". This study will be a non-randomized pilot trial using Cyclophosphamide and Sirolimus for the treatment of metastatic differentiated thyroid cancer. Patients will be treated with Sirolimus 4 mg, PO, days 1-28 as well as Cyclophosphamide 100 mg, PO, days 1-5 and 15-19. Cycle length will be 28 days. Pa...
What is the current status of trial NCT03099356?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2017-04-27. Estimated completion is 2026-12.
What conditions does trial NCT03099356 study?
This clinical trial studies the following conditions: Metastatic Thyroid Cancer.
What interventions are being tested in trial NCT03099356?
The interventions under investigation include: Cyclophosphamide (DRUG), Sirolimus (DRUG).
Who is sponsoring clinical trial NCT03099356?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03099356 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03099356's enrollment target sits among peer trials
22 1790th of 2000 higher than 207 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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