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Thyroid CancerPhase 2NCT00121628

A Phase 2, Open-label Study of AMG 706 to Treat Subjects With Locally Advanced or Metastatic Thyroid Cancer

A Phase 2 study testing AMG 706 in people with Thyroid Cancer, run by Amgen.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thyroid Cancer
What is being tested?
AMG 706
How many people
184 participants
Where
No sites listed yet
Study dates
Jul 2005to Oct 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Inclusion Criteria: - Histologically confirmed locally advanced or metastatic thyroid cancer - Measurable disease - Normal blood pressure (if history of hypertension, blood pressure must be controlled with medication) - Evidence of disease progression within 6 months before starting study (for differentiated thyroid cancer subjects) - Evidence of disease progression within 6 months before starting study OR symptomatic disease (for medullary thyroid cancer subjects) - Not a candidate for surgical resection, external beam radiotherapy, radioiodine therapy, or other local therapy - At least 18 years of age Exclusion Criteria: - Undifferentiated/anaplastic thyroid cancer - Untreated or symptomatic brain metastases - Prior malignancy, unless cured with treatment and no evidence of disease for greater than or equal to 3 years before starting study (history of thyroid cancer, in situ cervical cancer, or basal cell cancer of skin are exceptions) - Myocardial infarction or any unstable cardiac condition (e.g., congestive heart failure, unstable angina) within 1 year before starting study - Arterial thrombosis or deep vein thrombosis within 1 year before starting study

About this study

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.

Conditions
Thyroid Cancer
Being tested
AMG 706
Keywords
Thyroid cancer, Advanced thyroid cancer, Metastatic thyroid cancer, Medullary thyroid cancer, Follicular thyroid cancer, Papillary thyroid cancer, Hurthle cell thyroid cancer, Thyroid cancer treatments, Differentiated thyroid cancer and medullary thyroid cancer
Medical subject headings
Thyroid Neoplasms, Carcinoma, Medullary, Adenocarcinoma, Follicular, Thyroid Cancer, Papillary, Thyroid cancer, Hurthle cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AMG 706Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (10)

  1. Duration of response

  2. Progression Free Survival

  3. Changes in tumor markers

  4. overall survival time

  5. time to response

  6. Tumour Related Symptoms (medullary thyroid cancer arm)

  7. AMG 706 pharmacokinetic profile

  8. patient reported outcome (EQ-5D)

  9. Safety Endpoint: Incidence of treatment-emergent adverse events (including all, serious, treatment-related, and each by maximum severity).

  10. Pharmacokinetic Enpoint: AMG 706 pharmacokinetic parameters (Cmax, t1/2, AUC0-24,C24)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2005 (estimated)
  2. Study startJul 2005
  3. Primary completionNov 2006
  4. Study completionOct 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
184 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00121628
Sponsor's protocol ID
20040273
Status last verified
Oct 2013
First submitted
12 Jul 2005
Last updated
9 Oct 2013
Results posted
No

Publications

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

  • 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.

    PubMed 20739388

  • 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.

    PubMed 18596272

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AMG 706 in people with Thyroid Cancer, run by Amgen.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (complete response and partial response) as defined by modified RECIST. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00121628, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2013.

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