CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 53 enrolled
Drug / intervention
sunitinib + FOLFOX +6 moredrug
Likely dose
sunitinib + FOLFOX 37.5 mgfrom 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/NCT00599924
NCT00599924Phase 1Completed
CompareCT.gov

Phase I Study Of SU011248 In Combination With Oxaliplatin, Leucovorin, And 5-Fluorouracil In Patients With Advanced Solid Malignancies

Pfizer·interventional·Posted Jan 24, 2008·Updated Jul 15, 2015

In Brief

A Phase 1 clinical trial evaluating sunitinib + FOLFOX for Colorectal Neoplasms and Neoplasms. Completed, enrolled 53 participants across 3 sites.

Detailed Summary

This study determined the maximum tolerated dose and safety of SU011248 (sunitinib malate, SUTENT) in combination with FOLFOX \[Leucovorin + Fluorouracil (5-FU) + Oxaliplatin\]. Three different dosing regimens with starting doses of sunitinib at 37.5 mg/day (Schedule 2/2, Schedule 4/2, and Continuous Dosing) were tested in patients with advanced solid tumors, including colorectal cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColorectal Neoplasms, Neoplasms
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 24, 2008
Enrollment StartSep 1, 2005
Primary CompletionNov 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 18.4 years ago

Interventions

sunitinib + FOLFOXdrug

37.5 mg sunitinib + modified FOLFOX6 (Schedule 2/2)

sunitinib + FOLFOXdrug

50 mg sunitinib + modified FOLFOX6 (Schedule 2/2)

sunitinib + FOLFOXdrug

50 mg sunitinib + modified FOLFOX6 ( CRC, only Schedule 2/2)

sunitinib + FOLFOXdrug

37.5 mg sunitinib + modified FOLFOX6 (Schedule 4/2)

sunitinib + FOLFOXdrug

50 mg sunitinib + modified FOLFOX6 (Schedule 4/2)

sunitinib + FOLFOXdrug

37.5 mg sunitinib + modified FOLFOX6 (Continuous Dosing)

sunitinib + FOLFOXdrug

25 mg sunitinib + modified FOLFOX6 (Continuous Dosing)