To Evaluate the Safety, Tolerability and Pharmacokinetics of AMG 386 When Used in Combination With AMG 706, Bevacizumab, Sorafenib, or Sunitinib.
NCT00861419 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 88
Last updated 2017-02-08
Summary
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of AMG 386 when used in combination with AMG 706, bevacizumab, sorafenib, or sunitinib and that at least one dose level from each combination will be safe and well tolerated.
AMG 386 is a man-made medication that is designed to stop the development of blood vessels in cancer tissues. Cancer tissues rely on the development of new blood vessels, a process called angiogenesis, to obtain a supply of oxygen and nutrients to grow.
Conditions
Interventions
- DRUG
-
Sorafenib 400 mg PO (BID)
- DRUG
-
AMG 706
AMG 706 125 mg PO (QD)
- DRUG
-
AMG 706
AMG 706 75 mg PO (QD)
- DRUG
-
AMG 386
AMG 386 10 mg/kg IV (QW)
- DRUG
-
Sunitinib
Sunitinib 50 mg PO (QD)
- DRUG
-
Bevacizumab 15mg/kg IV Q3W
- DRUG
-
AMG 386
AMG 386 3 mg/kg IV (QW)
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
MD · Amgen
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-12-31
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