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NCT01364051 · ClinicalTrials.gov registry record · Phase 1
Cediranib Maleate and Selumetinib Sulfate in Treating Patients With Solid Malignancies
A Phase 1 study of Metastatic Melanoma and Refractory Malignant Solid Neoplasm, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
- 2
- Study locations
NCT01364051: Active Phase 1 study of Metastatic Melanoma and Refractory Malignant Solid Neoplasm, sponsored by National Cancer Institute (NCI).
NCT01364051 is a Phase 1 study of Metastatic Melanoma and Refractory Malignant Solid Neoplasm that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 19 participants, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (77% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01364051, a Phase 1 study of Metastatic Melanoma and Refractory Malignant Solid Neoplasm, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
- 2
- Study locations
Study Summary
This phase I trial studies the side effects and best dose of cediranib maleate and selumetinib sulfate in treating patients with solid malignancies. Cediranib maleate and selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Cediranib maleate may also stop the growth of tumor cells by blocking blood flow to the tumor.
Primary Outcome
MTD will be defined as the dose level below the lowest dose that induces dose limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6 new patients). Graded per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Selumetinib
- DRUG Cediranib
- OTHER Pharmacological Study
- DRUG Cediranib Maleate
Study Locations (2)
Florida
- Mayo Clinic in Florida - Jacksonville
Minnesota
- Mayo Clinic in Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2011-05-25 |
| Est. Completion | 2026-03-19 |
| Phase | Phase 1 |
What the registry record for NCT01364051 still lists
NCT01364051 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (77% lower).
The record links to 4 conditions, with Metastatic Melanoma appearing as the primary indexed condition, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT01364051 reports a single indexed study location in Florida, Minnesota.
Frequently Asked Questions
What is clinical trial NCT01364051 about?
NCT01364051 is a clinical study titled "Cediranib Maleate and Selumetinib Sulfate in Treating Patients With Solid Malignancies". This phase I trial studies the side effects and best dose of cediranib maleate and selumetinib sulfate in treating patients with solid malignancies. Cediranib maleate and selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Cediranib maleate may also...
What is the current status of trial NCT01364051?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2011-05-25. Estimated completion is 2026-03-19.
What conditions does trial NCT01364051 study?
This clinical trial studies the following conditions: Metastatic Melanoma, Refractory Malignant Solid Neoplasm, Unresectable Malignant Solid Neoplasm, Stage IV Cutaneous Melanoma AJCC v6 and v7.
What interventions are being tested in trial NCT01364051?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Selumetinib (DRUG), Cediranib (DRUG), Pharmacological Study (OTHER), Cediranib Maleate (DRUG).
Who is sponsoring clinical trial NCT01364051?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01364051 being conducted?
This trial has 2 study locations across Florida, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01364051's enrollment target sits among peer trials
19 69th of 91 higher than 22 of 91 other Metastatic Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Melanoma 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.
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