Head and Neck CancerPhase 2NCT01118065
Everolimus in Treating Patients With Progressive or Recurrent, Unresectable, or Metastatic Thyroid Cancer
A Phase 2 study testing everolimus in people with Head and Neck Cancer, run by Leiden University Medical Center at 1 site in Netherlands.
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 progressive or recurrent, unresectable, 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
- How many people
- 42 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2010to May 2012
- 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:
- Diagnosis of thyroid cancer meeting ≥ 1 of the following criteria:
- Progressive or recurrent disease
- Metastatic disease
- Unresectable disease
- Meeting any of the following thyroid cancer subtypes:
- Differentiated thyroid cancer (i.e., papillary, follicular, or Hurthle cell disease) that is radio-iodine refractory
- Undifferentiated thyroid cancer (i.e., anaplastic disease)
- Medullary thyroid cancer
- Must have received prior everolimus or other mTOR inhibitor therapy
- Patients with history of brain metastasis who are neurologically stable following definitive radiation and/or surgery and do not require corticosteroids allowed
PATIENT CHARACTERISTICS:
- Karnofsky performance score 70-100%
- ANC ≥ 1,500/mm^³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 5.6 mmol/L
- Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
- ALT and AST ≤ 2.5 times ULN (≤ 5 times ULN for known liver metastases)
- Serum creatinine ≤ 2 times ULN
- Negative pregnancy test
- No other malignancy, except nonmelanoma skin cancer, carcinoma in situ of the cervix, or a malignancy diagnosed and with no current evidence of malignancy within the past 2 years
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Leiden University Medical Center
Leiden, 2300 RC
Contact Person, 31-71-526-3486, h.w.kapiteijn@lumc.nl
About this study
Official title: A Phase II Study to Investigate the Efficacy of RAD001 (Afinitor®, Everolimus) in Patients With Irresectable Recurrent or Metastatic Differentiated, Undifferentiated (Anaplastic) and Medullary Thyroid Carcinoma
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 progressive or recurrent, unresectable, or metastatic thyroid cancer.
Read the detailed description
OBJECTIVES:
Primary
- To determine the efficacy of everolimus in patients with progressive or recurrent, unresectable, or metastatic differentiated thyroid carcinoma.
Secondary
- To determine maximum percentage of tumor reduction in these patients.
- To describe activity time to event endpoints.
- To assess toxicity.
- To determine evolution of serum thyroglobulin.
- To perform explorative pharmacogenomic, pharmacokinetic, and translational studies. (exploratory)
- To investigate efficacy of everolimus in patients with progressive or recurrent, unresectable or metastatic disease of undifferentiated (anaplastic) or medullary thyroid cancer.
OUTLINE: Patients receive oral everolimus once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
- Conditions
- Head and Neck Cancer
- Being tested
- everolimus
- Keywords
- anaplastic 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
Secondary outcomes (3)
Maximum percentage of tumor reduction
Activity time to event endpoints
Toxicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2010 (estimated)
- Study startMay 2010
- Primary completionMay 2012 (estimated)
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 Leiden University Medical CenterThe 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
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Ellen Kapiteijn, MD, PhD, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01118065
- Sponsor's protocol ID
- DUT-LUMC-CRAD001CNL08T
- Other IDs
- CDR0000672171, EUDRACT-2009-016669-27, EU-21037, NL-31245-058-10
- Status last verified
- May 2010
- First submitted
- 5 May 2010
- Last updated
- 12 Aug 2013
- Results posted
- No
Publications
de Wit D, Schneider TC, Moes DJ, Roozen CF, den Hartigh J, Gelderblom H, Guchelaar HJ, van der Hoeven JJ, Links TP, Kapiteijn E, van Erp NP. Everolimus pharmacokinetics and its exposure-toxicity relationship in patients with thyroid cancer. Cancer Chemother Pharmacol. 2016 Jul;78(1):63-71. doi: 10.1007/s00280-016-3050-6. Epub 2016 May 11.
PubMed 27169792
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study to Investigate the Efficacy of RAD001 (Afinitor®, Everolimus) in Patients With Irresectable Recurrent or Metastatic Differentiated, Undifferentiated (Anaplastic) and Medullary Thyroid Carcinoma
- ClinicalTrials.gov ID
- NCT01118065
- Acronym / sponsor ID
- DUT-LUMC-CRAD001CNL08T
- Conditions
- Head and Neck Cancer
- Keywords
- anaplastic 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
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- May 2012 (estimated)
- First posted
- 6 May 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 progressive or recurrent, unresectable, or metastatic thyroid cancer.
Detailed description
OBJECTIVES:
Primary
- To determine the efficacy of everolimus in patients with progressive or recurrent, unresectable, or metastatic differentiated thyroid carcinoma.
Secondary
- To determine maximum percentage of tumor reduction in these patients.
- To describe activity time to event endpoints.
- To assess toxicity.
- To determine evolution of serum thyroglobulin.
- To perform explorative pharmacogenomic, pharmacokinetic, and translational studies. (exploratory)
- To investigate efficacy of everolimus in patients with progressive or recurrent, unresectable or metastatic disease of undifferentiated (anaplastic) or medullary thyroid cancer.
OUTLINE: Patients receive oral everolimus once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
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 | – |
Primary outcome
Efficacy
3 secondary outcomes
Maximum percentage of tumor reduction
Activity time to event endpoints
Toxicity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2013.
- Derived from this study: PubMed 27169792de Wit D, Schneider TC, Moes DJ, Roozen CF, den Hartigh J, Gelderblom H, Guchelaar HJ, van der Hoeven JJ, Links TP, Kapiteijn E, van Erp NP. Everolimus pharmacokinetics and its exposure-toxicity relationship in patients with thyroid cancer. Cancer Chemother Pharmacol. 2016 Jul;78(1):63-71. doi: 10.1007/s00280-016-3050-6. Epub 2016 May 11.
Related trials for Head and Neck Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
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.
Ellen Kapiteijn, MD, PhD principal investigator
Leiden University Medical Center
1 site 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 in people with Head and Neck Cancer, run by Leiden University Medical Center at 1 site in Netherlands.
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: status not confirmed, as of the sponsor's last update on 12 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy. 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 NCT01118065, 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 12 Aug 2013.