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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Advanced Solid Tumors; Non Small Cell Lung Cancer

Treatments: Drug: docetaxel; Drug: sunitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00712504

A6181035

Details and patient eligibility

About

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.

Enrollment: 49 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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49 participants in 1 patient group

1

Experimental group

Description:

SU011248 in combination with docetaxel

Treatment:

Drug: docetaxel

Drug: sunitinib