Solid Tumors
Conditions
Keywords
solid tumor malignancy, SU011248, sunitinib, neoplasms
Brief summary
This study assesses the maximum tolerated dose, overall safety and antitumor activity of SU011248 in combination with gemcitabine in patients with advanced solid tumors
Interventions
DRUGSU011248; 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
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 gemcitabine or SU011248 * Hypertension that cannot be controlled by medications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the maximally tolerated dose of SU011248 (dosed on Schedule 4/2 or 2/1) when given in combination with gemcitabine | From screening until at least 28 days beyond discontinuation of study treatment |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the pharmacokinetics of SU011248 and gemcitabine when these drugs are co-administered | From screening until at least 28 days beyond discontinuation of study treatment |
| To preliminarily assess the antitumor activity of SU011248 and gemcitabine in patients with measurable disease | From screening until at least 28 days beyond discontinuation of study treatment |
Countries
United States
Outcome results
None listed