Solid Tumors
Conditions
Brief summary
Study of ABT-869 in Combination with Tarceva in Subjects with Solid Tumors
Sponsors
Genentech, Inc.
Abbott
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject must have a histologically or cytologically confirmed non-hematologic malignancy. * Subject must have an ECOG Score of 0-2. * Adequate organ function.
Exclusion criteria
* Subject has received targeted VEGF/PDGF therapy (tyrosine kinase inhibitor) therapy. Prior Avastin allowed. * Subject has untreated brain or meningeal metastases. * History of greater than 10% weight loss. * Has clinically relevant hemoptysis. * Subject has proteinuria CTC grade \> 1. * Must not have had radiation therapy or major surgery within 21 days of study day 1. * The subject currently exhibits symptomatic or persistent, uncontrolled hypertension defined as diastolic blood pressure (DBP) \> 100 mmHg or systolic blood pressure (SBP) \> 150 mmHg. Subjects may be re-screened if blood pressure is shown to be controlled with or without intervention. * The subject has a documented left ventricular ejection fraction (LVEF) \< 50%.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics | Day 7, 15, 21, 35 and Day 1 of every 8 weeks |
Outcome results
None listed