Single Dose Study of [14C]-Labelled AMG 706 in Patients With Advanced Solid Tumors
In order for a tumour to grow and spread to other parts of the body, it needs to have a blood supply. Certain proteins in the body, called cytokines or growth factors, have been shown to cause the growth of new blood vessels that supply tumours and therefore help the tumour to grow and spread. Motesanib (AMG 706) prevents these proteins from working, and may help to prevent the growth of tumours.
In the first part of this study, we will look at the way your body absorbs this drug into your blood, how your body changes and breaks down the drug, and then how the drug leaves your body in your urine and faeces.
In order to provide potential treatment benefit for the subjects who participated in the first part of the study, the second part of the study will allow subjects to continue on motesanib (AMG 706) treatment. The estimated length of this part of the study is unknown, and dependent on how subjects respond to motesanib (AMG 706).
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||An Open-label, Single Dose Study of the Mass Balance and Metabolic Disposition of Orally Administered [14C]-Labelled AMG 706 (Motesanib) Followed by Extended Treatment With Motesanib in Patients With Advanced Solid Tumors|
- Profile and identification of metabolites of [14C]-AMG 706 in plasma, urine, and faeces [ Designated as safety issue: No ]
- Pharmacokinetics of total radioactivity in plasma and whole blood [ Designated as safety issue: No ]
- The mass balance of [14C]-AMG 706 (as the percentage of the dose administered) in urine and faeces [ Designated as safety issue: No ]
- • Measure the area under the plasma concentration curve versus time of AMG 706, as well as determine half-life and time of maximum concentration of AMG 706. [ Designated as safety issue: No ]
- The subject incidences of serious adverse events, adverse events, and clinically significant changes in vital signs and clinical laboratory tests [ Designated as safety issue: Yes ]
|Study Start Date:||May 2009|
|Study Completion Date:||December 2010|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
Drug: AMG 706
Single oral dose of 125 mg AMG 706 (motesanib) containing 100 μCi of [14C]-AMG 706 followed by option to continue onto a treatment extension phase for potential treatment benefit. Subjects will be administered motesanib 125 mg (5 x 25 mg tablets) on a daily basis until subjects experience a dose-limiting toxicity (DLT), an unacceptable AE, disease progression, or voluntary withdrawal.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01386866