Breast Cancer, Neoplasms, Solid Tumors
Conditions
Keywords
solid tumor malignancy, SU011248, sunitinib, capecitabine, Phase 1
Brief summary
This study assesses the maximum tolerated dose, overall safety and antitumor activity of SU011248 in combination with capecitabine in patients with advanced solid tumors
Interventions
DRUGSU011248; Capecitabine
Dose finding study using SU011248 daily by oral capsule in a continuous regimen or administered for 4 out of every 6 weeks (Schedule 4/2) or 2 out of every 3 weeks (Schedule 2/1), with capecitabine administered 2 out of every 3 weeks until progression or unacceptable toxicity.
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 SU011248 or capecitabine. * Hypertension that cannot be controlled by medications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the maximally tolerated dose of SU011248 (dosed continuously or on a 4/2 or 2/1 Schedule) when given in combination with capecitabine. | From Screening until disease progression or discontinuation of the study |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the pharmacokinetics of SU011248 and capecitabine when these drugs are co-administered | From Cycle 1, Day 1 until discontinuation of the study |
| To preliminarily assess the antitumor activity of SU011248 and capecitabine in patients with measurable disease | From screening until disease progression or discontinuation of the study |
Countries
United States
Outcome results
None listed