Head and Neck CancerPhase 2NCT01164176
Everolimus in Treating Patients With Locally Advanced or Metastatic Thyroid Cancer
A Phase 2 study testing everolimus and laboratory biomarker analysis in people with Head and Neck Cancer, run by Yonsei University at 7 sites in South Korea.
Trial summary
RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well everolimus works in treating patients with locally advanced or metastatic thyroid cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- everolimus and laboratory biomarker analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 7 sitesSouth Korea
- Study dates
- Mar 2010to Oct 2014
- 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
DISEASE CHARACTERISTICS:
- Histologically confirmed thyroid cancer
- Progressive or refractory disease within the past 6 months
- Locally advanced or metastatic disease
- Measurable disease, defined as ≥ 1 measurable lesion defined by RECIST criteria
- Not amenable to surgical resection or external-beam radiotherapy or refractory to radioiodine therapy
- No untreated brain metastasis
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy > 3 months
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 9.0 g/dL
- Creatinine < 1.5 mg/dL
- Total bilirubin ≤ 1.0 times upper limit of normal (ULN)
- ALT and AST ≤ 3.0 times ULN
- No known hypersensitivity to the study drug
- No serious uncontrolled systemic intercurrent illness (e.g., infection or poorly controlled diabetes)
- No history of significant neurological or mental disorder, including seizures or dementia
- No other malignancy within the past 5 years except for carcinoma in situ of the cervix or nonmelanomatous carcinoma of the skin
- No active uncontrolled cardiac disease
- No myocardial infarction within the past 12 months
- Able to take oral medication
- No active peptic ulcer disease
- Must have patient compliance and geographic proximity for adequate follow-up
PRIOR CONCURRENT THERAPY:
- At least 30 days since prior mTor-inhibitor therapy (e.g., temsirolimus) or non-hormonal anticancer therapy
- At least 2 weeks since prior and no concurrent P-glycoprotein, CYP3A4, and CYP3A5 inhibitors or inducers
- No prior surgical procedure affecting absorption
- No other concurrent systemic chemotherapy, investigational drug, or radiotherapy
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
South Korea7 sites
Hallym University Sacred Heart Hospital
Anyang, Gyeonggi-do, 431-070
Yeungnam University Medical Center
Daegu, 712-749
National Cancer Center - Korea
Goyang, 410-769
Kosin Medical Center Gospel Hospital
Pusan, 602-702
Seoul National University Hospital
Seoul, 110-744
Yonsei Cancer Center at Yonsei University Medical Center
Seoul, 120-752
Gangnam Severance Hospital
Seoul, 135-720
About this study
Official title: An Open Label Multi-Center Phase II Study of RAD001 in Advanced Thyroid Cancer
RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well everolimus works in treating patients with locally advanced or metastatic thyroid cancer.
Read the detailed description
OBJECTIVES:
Primary
- To evaluate response rate in patients with locally advanced or metastatic, unresectable or refractory thyroid cancer treated with everolimus.
Secondary
- To evaluate overall survival of these patients treated with everolimus.
- To evaluate progression-free survival of these patients.
- To evaluate toxicity of this therapy in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral everolimus once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Blood samples are collected periodically for correlative studies.
After completion of study treatment, patients are followed up for 12 months.
- Conditions
- Head and Neck Cancer
- Being tested
- everolimus, laboratory biomarker analysis
- Keywords
- anaplastic thyroid cancer, insular thyroid cancer, recurrent thyroid cancer, stage III follicular thyroid cancer, stage III papillary thyroid cancer, stage IV follicular thyroid cancer, stage IV papillary thyroid cancer, thyroid gland medullary carcinoma
- Medical subject headings
- Head and Neck Neoplasms, Thyroid Carcinoma, Anaplastic, Thyroid Neoplasms, Adenocarcinoma, Follicular, Thyroid Cancer, Papillary, Carcinoma, Medullary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
everolimusDrug
laboratory biomarker analysisOther
| Study group | Role | What they receive |
|---|---|---|
| RAD001 group | Experimental | Not described Receives: Drug: everolimus; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Measured: every 3 month
Secondary outcomes (3)
Overall survival
Measured: participants will be followed until death
Progression-free survival
Measured: participants will be followed until disease progression or death
Toxicity profile
Measured: participants will be followed until disease progression or death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2010 (estimated)
- Study startMar 2010
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Byung Chul Cho, Principal investigator, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01164176
- Sponsor's protocol ID
- 4-2009-0542
- Other IDs
- YONSEI-CRAD001CKR12T, KCSG-HN-10-03
- Status last verified
- Feb 2014
- First submitted
- 15 Jul 2010
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Lim SM, Chang H, Yoon MJ, Hong YK, Kim H, Chung WY, Park CS, Nam KH, Kang SW, Kim MK, Kim SB, Lee SH, Kim HG, Na II, Kim YS, Choi MY, Kim JG, Park KU, Yun HJ, Kim JH, Cho BC. A multicenter, phase II trial of everolimus in locally advanced or metastatic thyroid cancer of all histologic subtypes. Ann Oncol. 2013 Dec;24(12):3089-94. doi: 10.1093/annonc/mdt379. Epub 2013 Sep 19.
PubMed 24050953
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Multi-Center Phase II Study of RAD001 in Advanced Thyroid Cancer
- ClinicalTrials.gov ID
- NCT01164176
- Acronym / sponsor ID
- 4-2009-0542
- Conditions
- Head and Neck Cancer
- Keywords
- anaplastic thyroid cancer, insular thyroid cancer, recurrent thyroid cancer, stage III follicular thyroid cancer, stage III papillary thyroid cancer, stage IV follicular thyroid cancer, stage IV papillary thyroid cancer, thyroid gland medullary carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 16 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well everolimus works in treating patients with locally advanced or metastatic thyroid cancer.
Detailed description
OBJECTIVES:
Primary
- To evaluate response rate in patients with locally advanced or metastatic, unresectable or refractory thyroid cancer treated with everolimus.
Secondary
- To evaluate overall survival of these patients treated with everolimus.
- To evaluate progression-free survival of these patients.
- To evaluate toxicity of this therapy in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral everolimus once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Blood samples are collected periodically for correlative studies.
After completion of study treatment, patients are followed up for 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RAD001 group | Experimental | Drug: everolimus, Other: laboratory biomarker analysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| everolimus | Drug | RAD001 group |
| laboratory biomarker analysis | Other | RAD001 group |
Primary outcome
Response rate
Time frame: every 3 month
3 secondary outcomes
Overall survival
Time frame: participants will be followed until death
Progression-free survival
Time frame: participants will be followed until disease progression or death
Toxicity profile
Time frame: participants will be followed until disease progression or death
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
- Derived from this study: PubMed 24050953Lim SM, Chang H, Yoon MJ, Hong YK, Kim H, Chung WY, Park CS, Nam KH, Kang SW, Kim MK, Kim SB, Lee SH, Kim HG, Na II, Kim YS, Choi MY, Kim JG, Park KU, Yun HJ, Kim JH, Cho BC. A multicenter, phase II trial of everolimus in locally advanced or metastatic thyroid cancer of all histologic subtypes. Ann Oncol. 2013 Dec;24(12):3089-94. doi: 10.1093/annonc/mdt379. Epub 2013 Sep 19.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Byung Chul Cho principal investigator
Yonsei University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing everolimus and laboratory biomarker analysis in people with Head and Neck Cancer, run by Yonsei University at 7 sites in South Korea.
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 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Response rate (time frame: every 3 month). 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 NCT01164176, which also lists 1 linked publication.
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 2 Dec 2014.