Study Complete
Sponsor ID
20080639

Single Dose Study of [14C]-labelled AMG 706 in Patients with Advanced Solid Tumors

Sponsor ID
20080639
Clinicaltrials.gov ID
NCT01386866
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

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).

Additional Study Details

Phase
Phase 1
Product
motesanib diphosphate
Type
Interventional
Masking
None (Open Label)
Enrollment
4
Additional Study Details

Protocol Summary

Primary Outcome Measures

Profile and identification of metabolites of [14C]-AMG 706 in plasma, urine, and faeces

Timeframe: Not Applicable

Pharmacokinetics of total radioactivity in plasma and whole blood

Timeframe: Not Applicable

The mass balance of [14C]-AMG 706 (as the percentage of the dose administered) in urine and faeces

Timeframe: Not Applicable

Secondary Outcome Measures

• 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.

Timeframe: Not Applicable

The subject incidences of serious adverse events, adverse events, and clinically significant changes in vital signs and clinical laboratory tests

Timeframe: Not Applicable

Study Documents

Study Synopsis
Available Language(s): English

Locations

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