NCT00102830

Brief Summary

The purpose of this study is to test the safety, tolerability and pharmacokinetic (PK) profile of AMG 386 after intravenous administration in adult subjects with advanced solid tumors.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 4, 2005

Completed
Last Updated

August 20, 2010

Status Verified

August 1, 2010

First QC Date

February 3, 2005

Last Update Submit

August 19, 2010

Conditions

Tumors

Keywords

Solid TumorMetastatic CancerAdvanced Solid Tumors

Outcome Measures

Primary Outcomes (2)

  • Adverse events, clinically significant changes in laboratory results, ECG, and vital signs, to be measured throughout the study.

  • Pharmacokinetic Profile of AMG 386 - blood levels of AMG 386 to be measured throughout the study.

Secondary Outcomes (4)

  • Changes in DCE-MRI imaging results measured at baseline, Week 1, and Week 4.

  • Changes in blood levels of angiogenic cytokines measured at baseline, Day 3, Weeks 2, 4, 10, and every 8 weeks thereafter.

  • Anti-AMG 386 antibody formation measured at baseline, weeks 2, 4, 6, and every 4 weeks thereafter.

  • Tumor response measure by CT scan at baseline, Week 4, and every 8 weeks thereafter.

Interventions

AMG 386DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must not have cardiac pacemakers or neurostimulators not specifically approved for use in the MRI environment;
  • Must not have metal implants, other than those approved as safe for use in MRI;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Lu JF, Rasmussen E, Karlan BY, Vergote IB, Navale L, Kuchimanchi M, Melara R, Stepan DE, Weinreich DM, Sun YN. Exposure-response relationship of AMG 386 in combination with weekly paclitaxel in recurrent ovarian cancer and its implication for dose selection. Cancer Chemother Pharmacol. 2012 May;69(5):1135-44. doi: 10.1007/s00280-011-1787-5. Epub 2012 Jan 1.

    PMID: 22210018DERIVED

Related Links

MeSH Terms

Conditions

NeoplasmsNeoplasm Metastasis

Interventions

trebananib

Condition Hierarchy (Ancestors)

Neoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 3, 2005

First Posted

February 4, 2005

Last Updated

August 20, 2010

Record last verified: 2010-08