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NCT00400569 · ClinicalTrials.gov registry record · Phase 2
Phase II Study of Sunitinib Malate for Metastatic and/or Surgically Unresectable Soft Tissue Sarcoma
A Phase 2 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
NCT00400569: Completed Phase 2 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT00400569 is a Phase 2 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 48 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00400569, a Phase 2 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
Study Summary
This is an open label single site Phase II clinical trial to identify a potentially promising therapy dose for Sunitinib malate. The study drug will be taken orally once daily on days 1 through 28 of each 42 day cycle. Treatment will be continued until there is either disease progression or cumulative/acute toxicity. All patients with unresectable or metastatic soft tissue sarcoma (STS): leiomyosarcoma, liposarcoma, fibrosarcoma, and malignant fibrous histiocytoma (MFH) seen at the Moffitt Cancer Center will be screened for eligibility to be enrolled in the study.
Primary Outcome
Objective Radiographic Response Rate. Response assessments were based on the longest diameter tumor measurements in accordance with Response Evaluation Criteria in Solid Tumors (RECIST).
Interventions
- DRUG Sunitinib Malate (SU011248)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2006-11 |
| Est. Completion | 2011-12 |
| Phase | Phase 2 |
What the finished NCT00400569 record still lists
NCT00400569 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 1 intervention - of which Sunitinib Malate (SU011248) is the first listed.
NCT00400569 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00400569 about?
NCT00400569 is a clinical study titled "Phase II Study of Sunitinib Malate for Metastatic and/or Surgically Unresectable Soft Tissue Sarcoma". This is an open label single site Phase II clinical trial to identify a potentially promising therapy dose for Sunitinib malate. The study drug will be taken orally once daily on days 1 through 28 of each 42 day cycle. Treatment will be continued until there is either disease progression or cumulati...
What is the current status of trial NCT00400569?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2006-11. Estimated completion is 2011-12.
What interventions are being tested in trial NCT00400569?
The interventions under investigation include: Sunitinib Malate (SU011248) (DRUG).
Who is sponsoring clinical trial NCT00400569?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00400569's enrollment target sits among peer trials
48 1265th of 2000 higher than 718 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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