CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 29 enrolled
Drug / intervention
pralatrexate +9 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01206465
NCT01206465Phase 1Completed
CompareCT.gov

A Phase I Clinical Trial of Sequential Pralatrexate Followed by a 48-hour Infusion of 5- Fluorouracil Given Every Other Week in Adult Patients With Solid Tumors

University of Nebraska·interventional·Posted Sep 21, 2010·Updated Dec 26, 2023

In Brief

A Phase 1 clinical trial evaluating pralatrexate, fluorouracil, and 8 other interventions for Unspecified Adult Solid Tumor, Protocol Specific. Completed, enrolled 29 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUnspecified Adult Solid Tumor, Protocol Specific
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 21, 2010
Enrollment StartSep 14, 2010
Primary CompletionFeb 4, 2015
Study CompletionJun 1, 2017
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 15.8 years ago

Interventions

pralatrexatedrug

Given IV

fluorouracildrug

Given IV

laboratory biomarker analysisother

Correlative studies

DNA analysisgenetic

Correlative studies

high performance liquid chromatographyother

Correlative studies

polymerase chain reactiongenetic

Correlative studies

nucleic acid sequencinggenetic

Correlative studies

pharmacological studyother

Correlative studies

pharmacogenomic studiesother

Correlative studies

polymorphism analysisgenetic

Correlative studies