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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00712504

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

9.8

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Solid Tumors Non Small Cell Lung Cancer	Drug: sunitinib Drug: docetaxel	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

49 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2004

Actual Primary Completion Date :

Nov 1, 2007

Actual Study Completion Date :

Nov 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 SU011248 in combination with docetaxel	Drug: sunitinib 25, 37.5 and 50 mg/day, oral, administered on an outpatient basis in two different dosing regimens: schedule 2/1 (2 weeks on, 1 week off) and schedule 4/2 (4 weeks on, 2 weeks off) Drug: docetaxel 60, 75, and 100 mg/m2 docetaxel administered every 21 days as a 1-hr IV infusion

Arm

Intervention/Treatment

Experimental: 1

SU011248 in combination with docetaxel

Drug: sunitinib

25, 37.5 and 50 mg/day, oral, administered on an outpatient basis in two different dosing regimens: schedule 2/1 (2 weeks on, 1 week off) and schedule 4/2 (4 weeks on, 2 weeks off)

Drug: docetaxel

60, 75, and 100 mg/m2 docetaxel administered every 21 days as a 1-hr IV infusion

Outcome Measures

Primary Outcome Measures

Type, incidence, severity, timing, seriousness, and relatedness of adverse events and laboratory abnormalities [November 2007]

Secondary Outcome Measures

Pharmacokinetic parameters of SU011248 (and its active metabolite, SU012662), and docetaxel. [November 2007]
Objective disease response [November 2007]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Birmingham	Alabama	United States	35233-2115
2	Pfizer Investigational Site	Birmingham	Alabama	United States	35233
3	Pfizer Investigational Site	Birmingham	Alabama	United States	35294
4	Pfizer Investigational Site	Nashville	Tennessee	United States	37232
5	Pfizer Investigational Site	Madison	Wisconsin	United States	53792