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Sponsored by: |
Amgen |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00861419 |
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.
Condition | Intervention | Phase |
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Advanced Solid Tumors |
Drug: Sorafenib Drug: AMG 706 Drug: AMG 386 Drug: Sunitinib Drug: Bevacizumab |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Parallel Assignment |
Official Title: | An Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AMG 386 With AMG 706, AMG 386 With Bevacizumab, AMG 386 With Sorafenib, and AMG 386 With Sunitinib in Adult Patients With Advanced Solid Tumors |
Estimated Enrollment: | 88 |
Study Start Date: | December 2005 |
Estimated Study Completion Date: | August 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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D: Experimental
3 mg/kg AMG 386 IV (QW) / 125 mg AMG 706 PO (QD)
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Drug: AMG 706
AMG 706 125 mg PO (QD)
Drug: AMG 386
AMG 386 3 mg/kg IV (QW)
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A: Experimental
3 mg/kg AMG 386 IV (QW) / 15 mg/kg bevacizumab IV (Q3W)
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Drug: Bevacizumab
Bevacizumab 15mg/kg IV Q3W
Drug: AMG 386
AMG 386 3 mg/kg IV (QW)
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B: Experimental
3 mg/kg AMG 386 IV (QW) / 75 mg AMG 706 PO (QD)
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Drug: AMG 706
AMG 706 75 mg PO (QD)
Drug: AMG 386
AMG 386 3 mg/kg IV (QW)
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E: Experimental
3 mg/kg AMG 386 IV (QW) / 400 mg sorafenib PO (BID)
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Drug: Sorafenib
Sorafenib 400 mg PO (BID)
Drug: AMG 386
AMG 386 3 mg/kg IV (QW)
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H: Experimental
10 mg/kg AMG 386 IV (QW) / 50 mg sunitinib PO (QD - 4 weeks on/2 weeks off)
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Drug: AMG 386
AMG 386 10 mg/kg IV (QW)
Drug: Sunitinib
Sunitinib 50 mg PO (QD)
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G: Experimental
3 mg/kg AMG 386 IV (QW) / 50 mg sunitinib PO (QD - 4 weeks on/2 weeks off)
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Drug: Sunitinib
Sunitinib 50 mg PO (QD)
Drug: AMG 386
AMG 386 3 mg/kg IV (QW)
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C: Experimental
10 mg/kg AMG 386 IV (QW) / 15 mg/kg bevacizumab IV (Q3W)
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Drug: AMG 386
AMG 386 10 mg/kg IV (QW)
Drug: Bevacizumab
Bevacizumab 15mg/kg IV Q3W
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F: Experimental
10 mg/kg AMG 386 IV (QW) / 400 mg sorafenib PO (BID)
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Drug: Sorafenib
Sorafenib 400 mg PO (BID)
Drug: AMG 386
AMG 386 10 mg/kg IV (QW)
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Amgen Call Center | 866-572-6436 |
United States, Arizona | |
Research Site | Recruiting |
Scottsdale, Arizona, United States | |
United States, California | |
Research Site | Recruiting |
Santa Monica, California, United States | |
United States, Nevada | |
Research Site | Recruiting |
Las Vegas, Nevada, United States | |
United States, Pennsylvania | |
Research Site | Recruiting |
Pittsburgh, Pennsylvania, United States | |
United States, Texas | |
Research Site | Recruiting |
Houston, Texas, United States |
Study Director: | MD | Amgen |
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20050170 |
Study First Received: | March 12, 2009 |
Last Updated: | March 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00861419 History of Changes |
Health Authority: | United States: Food and Drug Administration |
AMG 386 AMG 706 Bevacizumab Sorafenib |
Angiogenesis Inhibitors Combination Therapy Peptibody Sunitinib |
Sunitinib Bevacizumab Protein Kinase Inhibitors Angiogenesis Inhibitors Sorafenib |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors Bevacizumab Angiogenesis Inhibitors |
Protein Kinase Inhibitors Pharmacologic Actions Sunitinib Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors Sorafenib |