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NCT01206465 · ClinicalTrials.gov registry record · Phase 1
Pralatrexate and Fluorouracil in Treating Patients With Recurrent Solid Tumors
A Phase 1 study of Unspecified Adult Solid Tumor, Protocol Specific, sponsored by University of Nebraska.
- Completed
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
- 1
- Study location
NCT01206465: Completed Phase 1 study of Unspecified Adult Solid Tumor, Protocol Specific, sponsored by University of Nebraska.
NCT01206465 is a Phase 1 study of Unspecified Adult Solid Tumor, Protocol Specific that has completed, run by University of Nebraska. The registered enrollment target is 29 participants, below the 501-participant average among 83 other Unspecified Adult Solid Tumor, Protocol Specific trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01206465, a Phase 1 study of Unspecified Adult Solid Tumor, Protocol Specific, has completed, sponsored by University of Nebraska.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
- 1
- Study location
Study Summary
RATIONALE: Pralatrexate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving pralatrexate together with fluorouracil may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of pralatrexate when given together with fluorouracil in treating patients with recurrent solid tumors
Primary Outcome
Recommended dose of PDX given in combination with a fixed dose of 5-FU administered as a 48-hour infusion given every other weekMaximum tolerated dose will have been exceeded when 2 patients entered at a given dose level experience specified dose-limiting toxicities in the initial cycle
Conditions Studied
Interventions
- OTHER laboratory biomarker analysis
- DRUG fluorouracil
- GENETIC DNA analysis
- OTHER high performance liquid chromatography
- DRUG pralatrexate
Study Locations (1)
Nebraska
- University of Nebraska Medical Center, Eppley Cancer Center - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2010-09-14 |
| Est. Completion | 2017-06-01 |
| Phase | Phase 1 |
What the finished NCT01206465 record still lists
NCT01206465 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 501-participant average among 83 other Unspecified Adult Solid Tumor, Protocol Specific trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Unspecified Adult Solid Tumor, Protocol Specific appearing as the primary indexed condition, and to 5 interventions - of which laboratory biomarker analysis is the first listed.
NCT01206465 reports a single indexed study location in Nebraska.
Frequently Asked Questions
What is clinical trial NCT01206465 about?
NCT01206465 is a clinical study titled "Pralatrexate and Fluorouracil in Treating Patients With Recurrent Solid Tumors". RATIONALE: Pralatrexate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving pralatr...
What is the current status of trial NCT01206465?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2010-09-14. Estimated completion is 2017-06-01.
What conditions does trial NCT01206465 study?
This clinical trial studies the following conditions: Unspecified Adult Solid Tumor, Protocol Specific.
What interventions are being tested in trial NCT01206465?
The interventions under investigation include: laboratory biomarker analysis (OTHER), fluorouracil (DRUG), DNA analysis (GENETIC), high performance liquid chromatography (OTHER), pralatrexate (DRUG).
Who is sponsoring clinical trial NCT01206465?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01206465 being conducted?
This trial has 1 study location across Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Unspecified Adult Solid Tumor, Protocol Specific
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01206465's enrollment target sits among peer trials
29 55th of 83 higher than 28 of 83 other Unspecified Adult Solid Tumor, Protocol Specific trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Unspecified Adult Solid Tumor, Protocol Specific 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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