NCT00121628

Brief Summary

The purpose of the study is to determine if AMG 706 will have clinically meaningful anti-tumor activity in subjects with locally advanced or metastatic thyroid cancer who are not candidates for radioactive iodine therapy or local therapies.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
184

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2005

Longer than P75 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 21, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

October 9, 2013

Status Verified

October 1, 2013

Enrollment Period

1.3 years

First QC Date

July 12, 2005

Last Update Submit

October 7, 2013

Conditions

Thyroid Cancer

Keywords

Thyroid cancerAdvanced thyroid cancerMetastatic thyroid cancerMedullary thyroid cancerFollicular thyroid cancerPapillary thyroid cancerHurthle cell thyroid cancerThyroid cancer treatmentsDifferentiated thyroid cancer and medullary thyroid cancer

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate (complete response and partial response) as defined by modified RECIST

Secondary Outcomes (10)

  • Duration of response

  • Progression Free Survival

  • Changes in tumor markers

  • overall survival time

  • time to response

  • +5 more secondary outcomes

Interventions

AMG 706DRUG

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Sherman SI, Wirth L, Droz J-P, Hofmann M, Bastholt L, Martins R, Licitra L, Eschenberg M, Sun Y-N, J

    BACKGROUND

  • Bass MB, Sherman SI, Schlumberger MJ, Davis MT, Kivman L, Khoo HM, Notari KH, Peach M, Hei YJ, Patterson SD. Biomarkers as predictors of response to treatment with motesanib in patients with progressive advanced thyroid cancer. J Clin Endocrinol Metab. 2010 Nov;95(11):5018-27. doi: 10.1210/jc.2010-0947. Epub 2010 Aug 25.

    PMID: 20739388DERIVED

  • Sherman SI, Wirth LJ, Droz JP, Hofmann M, Bastholt L, Martins RG, Licitra L, Eschenberg MJ, Sun YN, Juan T, Stepan DE, Schlumberger MJ; Motesanib Thyroid Cancer Study Group. Motesanib diphosphate in progressive differentiated thyroid cancer. N Engl J Med. 2008 Jul 3;359(1):31-42. doi: 10.1056/NEJMoa075853.

    PMID: 18596272DERIVED

Related Links

MeSH Terms

Conditions

Thyroid NeoplasmsCarcinoma, MedullaryAdenocarcinoma, FollicularThyroid Cancer, PapillaryThyroid cancer, Hurthle cell

Interventions

motesanib diphosphate

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid DiseasesCarcinoma, NeuroendocrineNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms, Ductal, Lobular, and MedullaryNeoplasms, Nerve TissueAdenocarcinoma, Papillary

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2005

First Posted

July 21, 2005

Study Start

July 1, 2005

Primary Completion

November 1, 2006

Study Completion

October 1, 2010

Last Updated

October 9, 2013

Record last verified: 2013-10