Single Dose Study of [14C]-Labelled AMG 706 in Patients With Advanced Solid Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01386866|
Recruitment Status : Completed
First Posted : July 1, 2011
Last Update Posted : July 15, 2011
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).
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumors||Drug: AMG 706||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||November 2010|
|Actual Study Completion Date :||December 2010|
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.
- Profile and identification of metabolites of [14C]-AMG 706 in plasma, urine, and faeces
- Pharmacokinetics of total radioactivity in plasma and whole blood
- The mass balance of [14C]-AMG 706 (as the percentage of the dose administered) in urine and faeces
- • 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.
- The subject incidences of serious adverse events, adverse events, and clinically significant changes in vital signs and clinical laboratory tests
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01386866