A Study To Find The Best Doses Of SU011248 And Gemcitabine When Given Together To Patients With Advanced Solid Tumors

NCT ID: NCT00615446

Last Updated: 2010-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2009-05-31

Brief Summary

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This study assesses the maximum tolerated dose, overall safety and antitumor activity of SU011248 in combination with gemcitabine in patients with advanced solid tumors

Detailed Description

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Conditions

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Solid Tumors

Keywords

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solid tumor malignancy, SU011248, sunitinib, neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

SU011248; Gemcitabine

Intervention Type DRUG

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

Interventions

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SU011248; Gemcitabine

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

Intervention Type DRUG

Other Intervention Names

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Sutent, sunitinib, SU11248, Gemzar

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* Prior treatment with either gemcitabine or SU011248
* Hypertension that cannot be controlled by medications
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Boston, Massachusetts, United States

Site Status

Pfizer Investigational Site

Boston, Massachusetts, United States

Site Status

Pfizer Investigational Site

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 23511559 (View on PubMed)

Related Links

Other Identifiers

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A6181041

Identifier Type: -

Identifier Source: org_study_id