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

NCT01386866 | Completed Phase 1

• 1 other identifier: 20080639
• Study Type: interventional
• Target: 4
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Advanced Solid Tumors

Keywords

AMG 706; Motesanib; Amgen; Phase 1

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (2)

• • 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

Study Arms (1)

A

EXPERIMENTAL

Drug: AMG 706

Interventions

AMG 706 DRUG

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.

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with a pathologically documented and definitively diagnosed advanced solid tumor(excluding tumors that may significantly interfere with the absorption, metabolism, or excretion of the test article, such as primary or metastatic liver tumor with approximately \>50% of liver tissue involvement) that is refractory to standard treatment or for which no curative therapy is available
• Eastern Cooperative Oncology Group performance status of 0-1
• Man or woman (male or female), age \> 18 years
• Ability to understand and sign an Independent Ethics Committee (IEC) Approved informed
• Subjects must also fulfil Haematological, Renal, Hepatic and Coagulation criteria (not listed)

You may not qualify if:

• Acute disease state (e.g. nausea, vomiting, fever, diarrhea) within 7 days of Day 1
• History of documented arterial or venous thrombosis within 1 year of Day 1
• History of bleeding diathesis or bleeding within 14 days of Day 1, or hypercoagulopathy syndrome
• History of life-threatening ventricular arrhythmia (e.g. sustained ventricular tachycardia)
• History of pulmonary hemorrhage or gross hemoptysis (1/2 teaspoon of bright red blood or more) within 6 months of Day 1
• Central nervous system metastases (exception: subjects with treated, asymptomatic central nervous system metastases, those who have been clinically stable in the judgment of the investigator and off steroids for at least 30 days before Day 1 are eligible)
• Subjects with non-small cell lung cancer (NSCLC)
• Subjects with head and neck cancer
• Subjects with ovarian cancer
• Subjects with large central (located adjacent to or within the hilum or mediastinum) tumor lesions ≥ 3 cm, regardless of histology
• Uncontrolled hypertension: average systolic blood pressure \> 150 mm Hg or average diastolic blood pressure \> 90 mm Hg (average blood pressure of the three separate blood pressure values measured within 10 minutes during screening)
• Systemic chemotherapy within 28 days of Day 1
• Radiotherapy within 28 days of Day 1 or within 14 days of Day 1 for peripheral lesions
• Experimental or approved antibody therapy within 6 weeks before Day 1
• Concurrent or prior (within 4 weeks prior to Day 1 of 5 half-lives of the medication which ever is longer) treatment with potent CYP3A inducers, including but not limited to : phenytoin, carbamazepine, rifampicin, phenobarbital and St John's Wort

Sponsors & Collaborators

• Amgen: lead

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Interventions

motesanib diphosphate

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 14, 2011
• First Posted: July 1, 2011
• Study Start: May 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: December 1, 2010
• Last Updated: July 15, 2011

Record last verified: 2011-07