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NCT01391962 · ClinicalTrials.gov registry record · Phase 2
Sunitinib or Cediranib for Alveolar Soft Part Sarcoma
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 34
- Enrollment target
NCT01391962: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT01391962 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 34 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01391962, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 34 participants
- Enrollment target
Study Summary
Background: * Alveolar soft part sarcoma (ASPS) is a rare, highly vascular tumor accounting for less than 1% of soft tissue sarcomas. There is no effective systemic treatment for patients with metastatic ASPS. Little is known with regards to relevant molecular markers as potential therapeutic targets. * Cediranib (AZD2171) and sunitinib (SU011248), oral small molecule inhibitors of vascular endothelial growth factor (VEGF) receptor tyrosine kinases, are showing preliminary evidence of activity in patients with ASPS. Objectives: * Part I: Determine the objective response rate (ORR) of single-agent cediranib and single-agent sunitinib malate in patients with advanced ASPS. * Part II: Determine the ORR of cediranib in patients who progress on the sunitinib arm, and determine the ORR of sunitinib in patients who progress on the cediranib arm. * Determine the progression-free survival (PFS) at 24 weeks for single-agent cediranib and single-agent sunitinib malate in patients with advanced ASPS. Eligibility: * Patients aged greater than or equal to 16 years with histologically or cytologically confirmed metastatic ASPS. * Patients must show evidence of objective disease progression per Response evaluation criteria in solid tumors (RECIST)v1 on scans within the 3-month period immediately preceding enrollment. Both scans used to determine disease progression should have been obtained within this 6-month period. * Patients with newly diagnosed, unresectable, measurable, metastatic ASPS who show clinical evidence of disease progression will be eligible. * Patients must not have received treatment with any VEGF receptor tyrosine kinase inhibitor (e.g., cediranib, sunitinib, pazopanib, sorafenib); however, prior treatment with bevacizumab is allowed. Design: * Part I: Patients will be randomized to receive cediranib (30 mg) or sunitinib malate (37.5 mg) orally, once a day in 28-day cycles. * Part II: At the time of disease progression, patients will cross over to the oth
Interventions
- DRUG Sunitinib
- DRUG Cediranib
- OTHER Prochlorperazine
- OTHER Promethazine
- OTHER Benzodiazepine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2011-07-18 |
| Est. Completion | 2026-01-16 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01391962
The ClinicalTrials.gov registry entry for NCT01391962 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Sunitinib is the first listed.
NCT01391962 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01391962 about?
NCT01391962 is a clinical study titled "Sunitinib or Cediranib for Alveolar Soft Part Sarcoma". Background: * Alveolar soft part sarcoma (ASPS) is a rare, highly vascular tumor accounting for less than 1% of soft tissue sarcomas. There is no effective systemic treatment for patients with metastatic ASPS. Little is known with regards to relevant molecular markers as potential therapeutic targe...
What is the current status of trial NCT01391962?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2011-07-18. Estimated completion is 2026-01-16.
What interventions are being tested in trial NCT01391962?
The interventions under investigation include: Sunitinib (DRUG), Cediranib (DRUG), Prochlorperazine (OTHER), Promethazine (OTHER), Benzodiazepine (OTHER).
Who is sponsoring clinical trial NCT01391962?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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