Clinical trial · Interventional

Study Of SU011248 In Combination With Docetaxel In Patients With Advanced Cancer

A Phase 1 Safety And Pharmacokinetic Study Of SU011248 In Combination With Docetaxel In Patients With Advanced Solid Tumors

NCT00712504CI-TRIAL-00001776completedPhase 1ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

This study is determining the maximum tolerated dose and safety of SU011248 (sunitinib malate, SUTENT) in combination with docetaxel (Taxotere). Several dosing regimens will be tested in patients with advanced solid tumors, including non small cell lung cancer.

Conditions

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Advanced Solid Tumors	Solid Neoplasm	CURATED_BROADER	0.80
Non Small Cell Lung Cancer	Lung Non-Small Cell Carcinoma	ALIAS	0.90

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
docetaxel	Drug	Docetaxel	ALIAS
sunitinib	Drug	Sunitinib	ALIAS

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
1
description
SU011248 in combination with docetaxel
interventionNames
1. Drug: sunitinib
2. Drug: docetaxel

Primary outcomes (1)

measure
Type, incidence, severity, timing, seriousness, and relatedness of adverse events and laboratory abnormalities
timeFrame
November 2007

Secondary outcomes (2)

measure
Pharmacokinetic parameters of SU011248 (and its active metabolite, SU012662), and docetaxel.
timeFrame
November 2007
measure

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

Advanced solid tumor malignancy ECOG 0 or 1

Exclusion Criteria:

Prior treatment with with high-dose chemotherapy requiring stem cell rescue Prior irradiation to ≥25% of the bone marrow (e.g. whole pelvis=25%) Patients with centrally located lung lesions unless recently treated with radiotherapy

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Jul 1, 2004
Primary completion: Nov 1, 2007
Completion: Nov 1, 2007
First posted: Jul 10, 2008
Last update posted: Nov 11, 2008
Enrollment: 49 (actual)
Lead sponsor: Pfizer INDUSTRY
Keywords: advanced solid tumors, non small cell lung cancer, pulmonary neoplasms, sunitinib (SUTENT), docetaxel (Taxotere), Angiogenesis Inhibitors

Data updated 22 days agoSource updated Nov 11, 2008source: clinicaltrials

Locations

Locations by country (5)

Country	Sites	Recruiting
United States	5	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.