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Study Of Sunitinib Plus FOLFOX In Patients With Solid Tumors

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Colorectal Neoplasms; Neoplasms

Intervention: sunitinib + FOLFOX (Drug); sunitinib + FOLFOX (Drug); sunitinib + FOLFOX (Drug); sunitinib + FOLFOX (Drug); sunitinib + FOLFOX (Drug); sunitinib + FOLFOX (Drug); sunitinib + FOLFOX (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Secondary outcome:

Objective Response (OR)

Maximum Plasma Concentration (Cmax) of Sunitinib

Time to Cmax (Tmax) of Sunitinib

Minimum Plasma Concentration (Cmin) of Sunitinib

Clearance (CL/F) of Sunitinib

Area Under Plasma Concentration-Time Profile From Time Zero to Twenty-Four Hours Postdose (AUC24) of Sunitinib

Terminal Phase Half-Life (t1/2) of Sunitinib

Cmax of SU-012662 (Sunitinib's Metabolite)

Tmax of SU-012662 (Sunitinib's Metabolite)

Cmin of SU-012662 (Sunitinib's Metabolite)

AUC24 for SU-012662 (Sunitinib's Metabolite)

CL/F of SU-012662 (Sunitinib's Metabolite)

T1/2 of SU-012662 (Sunitinib's Metabolite)

Cmax of Free Platinum

Tmax of Free Platinum

Area Under the Plasma Concentration-Time Profile From Time Zero to Infinity (AUCinf) for Free Platinum

T1/2 for Free Platinum

Cmax of Total Platinum

Tmax of Total Platinum

Area Under the Plasma Concentration-Time Profile From Time Zero to Forty-Eight Hours (AUC48) for Total Platinum

Steady State Concentration (Css) of Fluorouracil (5-FU)

Steady State Clearance (CLss) of 5-FU

Area Under the Curve (AUC) of 5-FU

Cmax of 5-FU

T1/2 of Free Platinum, Total Platinum, and 5-FU

CL/F of Free Platinum, Total Platinum, and 5-FU

Cmin of Free Platinum, Total Platinum, and 5-FU

Volume Endothelial Transfer Constant (Ktrans) of Tumors in a Selected Group of Subjects Assessed by Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI)

Initial Area Dnder the Contrast Agent Concentration-Time Curve (IAUC) of Tumors in a Selected Group of Subjects Assessed by DCE-MRI

Detailed description: Study Design: Treatment, Single Group Assignment (7 cohorts), Open Label, Non-Randomized, Safety Study.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Advanced solid tumor malignancy (during expansion at the maximum tolerated dose,

entry will be limited to patients wtih adenocarcinoma of the colon or rectum)

- Eastern Cooperative Oncology Group (ECOG) 0 or 1

Exclusion Criteria:

- Prior treatment with more than 6 cycles of traditional alkylating agent-based

chemotherapy regimens

- Prior treatment with more than 2 cycles of carboplating-based chemotherapy regimens

- For colorectal cancer patients in the expanded cohorts, prior treatment with more

than 2 systemic chemotherapy regimens in the metastatic setting

Locations and Contacts

Pfizer Investigational Site, Aurora, Colorado 80045, United States

Pfizer Investigational Site, Nashville, Tennessee 37232, United States

Pfizer Investigational Site, Dallas, Texas 75246, United States

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: September 2005
Last updated: June 22, 2015

Page last updated: August 23, 2015

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