A Study To Find The Best Doses Of SU011248 And Gemcitabine When Given Together To Patients With Advanced Solid Tumors
A Phase 1 Study Of SU011248 And Gemcitabine In Patients With Advanced Solid Tumors
1 other identifier
interventional
44
1 country
3
Brief Summary
This study assesses the maximum tolerated dose, overall safety and antitumor activity of SU011248 in combination with gemcitabine in patients with advanced solid tumors
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2005
Longer than P75 for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
February 1, 2008
CompletedFirst Posted
Study publicly available on registry
February 14, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedApril 30, 2010
April 1, 2010
4.2 years
February 1, 2008
April 29, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine the maximally tolerated dose of SU011248 (dosed on Schedule 4/2 or 2/1) when given in combination with gemcitabine
From screening until at least 28 days beyond discontinuation of study treatment
Secondary Outcomes (2)
To evaluate the pharmacokinetics of SU011248 and gemcitabine when these drugs are co-administered
From screening until at least 28 days beyond discontinuation of study treatment
To preliminarily assess the antitumor activity of SU011248 and gemcitabine in patients with measurable disease
From screening until at least 28 days beyond discontinuation of study treatment
Study Arms (1)
A
EXPERIMENTALInterventions
Dose finding study using SU011248 (sunitinib) daily by oral capsule in 4/2 (administered for 4 out of every 6 weeks) or 2/1 (administered for 2 out of every 3 weeks) schedule with gemcitabine administered on Days 1, 8, 22 and 29 on Schedule 4/2 and Days 1 and 8 on Schedule 2/1 until progression or unacceptable toxicity
Eligibility Criteria
You may qualify if:
- Patients with diagnosis of a solid cancer which is not responsive to standard therapy or for which no standard therapy exists
- Patient has good performance status (ECOG 0 or 1)
You may not qualify if:
- Prior treatment with either gemcitabine or SU011248
- Hypertension that cannot be controlled by medications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (3)
Pfizer Investigational Site
Boston, Massachusetts, 02114, United States
Pfizer Investigational Site
Boston, Massachusetts, 02115, United States
Pfizer Investigational Site
Boston, Massachusetts, 02215, United States
Related Publications (1)
Michaelson MD, Zhu AX, Ryan DP, McDermott DF, Shapiro GI, Tye L, Chen I, Stephenson P, Patyna S, Ruiz-Garcia A, Schwarzberg AB. Sunitinib in combination with gemcitabine for advanced solid tumours: a phase I dose-finding study. Br J Cancer. 2013 Apr 16;108(7):1393-401. doi: 10.1038/bjc.2013.96. Epub 2013 Mar 19.
PMID: 23511559DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 1, 2008
First Posted
February 14, 2008
Study Start
March 1, 2005
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
April 30, 2010
Record last verified: 2010-04