MedTrace Logo

Study Of Sunitinib Plus FOLFOX In Patients With Solid Tumors

NCT00599924 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2015-07-15

Study results available
· View outcomes & findings →

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.

Conditions

  • Colorectal Neoplasms
  • Neoplasms

Interventions

DRUG

sunitinib + FOLFOX

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

DRUG

sunitinib + FOLFOX

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

DRUG

sunitinib + FOLFOX

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

DRUG

sunitinib + FOLFOX

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

DRUG

sunitinib + FOLFOX

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

DRUG

sunitinib + FOLFOX

37.5 mg sunitinib + modified FOLFOX6 (Continuous Dosing)

DRUG

sunitinib + FOLFOX

25 mg sunitinib + modified FOLFOX6 (Continuous Dosing)

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2008-11-30
Completion
2008-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00599924 on ClinicalTrials.gov