Medullary Thyroid CarcinomaPhase 2SUMMITNCT01736878
Efficacy and Safety Study of Sorafenib to Treat Advanced Medullary Thyroid Carcinoma
A Phase 2 study testing Sorafenib in people with Medullary Thyroid Carcinoma, run by Eanm Research Ltd at 1 site in Germany.
Trial summary
The purpose of his study is to evaluate the efficacy and safety of Sorafenib versus placebo in subjects with locally advanced medullary thyroid cancer (MTC). The primary study objective is to compare the Progression-free Survival (PFS) of the Sorafenib treatment group with the placebo treatment group in patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medullary Thyroid Carcinoma
- What is being tested?
- Sorafenib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2012to Apr 2013
- 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
Who may be able to join
- Inpatient or outpatient ≥ 18 years of age
- Histologically confirmed medullary thyroid carcinoma
- Recurrent or persistent local disease and/or distant metastases
- No more than one prior line of systemic therapy
- Best available supportive care to control (endocrine) symptoms
- At least one defined lesion in CT or MRI evaluable for Response Evaluation Criteria in Solid Tumors (RECIST v1.1), or at least one defined lesion in CT or MRI not evaluable by RECIST in combination with elevated tumour markers
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- Progression within previous 12 months
- Hb > 8g/dl, white blood cells (WBC) >3.000 cells/mm³ (ANC > 1.500 cells/mm³), platelets > 100.000 cells/mm³, bilirubin < 2mg/dl, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x upper limit of normal (ULN)
- Performance status: WHO ≤ 2; Karnofsky index ≥ 50%
- Sufficient renal function (creatinin <1.5 mg/dl and creatinin clearance > 30ml/min)
- International normalized ratio (INR) and partial thromboplastin time (PTT) < 1.5 x ULN
- No acute infections
- Staging studies (MRT or CT and Calcitonin or CEA) completed within four weeks of protocol randomisation
- Women of childbearing potential with negative serum pregnancy test
- Women and men of childbearing potential using adequate contraception
- Signed and dated written informed consent
Who cannot join
- Unresolved toxicity (i.e. neurotoxicity) attributed to any prior therapy higher than National Cancer Institute-Common Toxicity Criteria for Adverse Effects (NCI-CTCAE version 4) Grade 2 (excluding cases of alopecia)
- Patients with history of allergic or hypersensitivity reaction to study drug or placebo or their excipients
- Current participation in another investigational trial
- Patients with significant cardiovascular disease
- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy other than beta-blockers or digoxin
- Congenital long corrected QT interval (QTc) syndrome, history of drug induced QTc prolongation, or QTc interval unmeasurable or more than 450 ms
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- Abnormal serum electrolytes such as potassium, magnesium and calcium
- Uncontrolled hypertension, despite optimal management
- Major surgery, open biopsy, or significant traumatic injury within 30 days prior to randomization
- Non-healing wound, ulcer, or bone fracture
- Evidence or history of bleeding diathesis or coagulopathy disorder
- Hemorrhage/bleeding event ≥ Grade 3
- Thrombotic or embolic events including transient ischemic attacks within the past 6 months
- Subjects with symptomatic brain metastases or Subjects with brain metastases under corticosteroid treatment
- Pregnant or breast-feeding patients
- Patients with uncontrolled infections
- Known HIV infection or infection with hepatitis B or C
- Immunosuppression
- Subjects with seizure disorder requiring medication • Subjects undergoing renal dialysis
- Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results
- Any malabsorption condition
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Ulm, Clinic for Nuclear Medicine
Ulm, Baden-Wurttemberg, D-89081
About this study
Official title: Randomized Double-blind Placebo Controlled Phase II Study to Evaluate the Efficacy and Safety of Sorafenib Treatment in Patients With Advanced (Recurrent, Persistent and/or Metastasizing) Medullary Thyroid Carcinoma
The purpose of his study is to evaluate the efficacy and safety of Sorafenib versus placebo in subjects with locally advanced medullary thyroid cancer (MTC). The primary study objective is to compare the Progression-free Survival (PFS) of the Sorafenib treatment group with the placebo treatment group in patients with advanced MTC.
- Conditions
- Medullary Thyroid Carcinoma
- Being tested
- Sorafenib
- Keywords
- Medullary Thyroid Carcinoma, Sorafenib, Efficacy
- Medical subject headings
- Carcinoma, Medullary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SorafenibDrug
| Study group | Role | What they receive |
|---|---|---|
| Sorafenib tablets | Experimental | Oral administration of Sorafenib tablets, 400 mg bid, until disease progression or unacceptable toxicity Receives: Drug: Sorafenib |
| Placebo tablets | Placebo comparator | Oral administration of Placebo tablets until disease progression, afterwards continuation with Sorafenib at the discretion of the investigator Receives: Drug: Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
The proportion of patients with PFS in the Sorafenib group and the Placebo group will be compared by log rank test and Kaplan-Meier plot.
Measured: from the date of randomisation until the date of radiological or biochemical progression or death. An average of 9 months is assumed.
Secondary outcomes (1)
Time to Progression (TPP)
The average TTP in the Sorafenib group and the Placebo group will be compared.
Measured: from the date of randomisation until the date of confirmed radiological or biochemical progression. An average of 9 months is assumed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionApr 2013
- Study completionApr 2013
Why it stopped: Study was withdrawn due to unanticipated hassle in patient recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medullary Thyroid CarcinomaStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eanm Research Ltd
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01736878
- Sponsor's protocol ID
- EARL-2
- Other IDs
- 2011-006250-90
- Acronym
- SUMMIT
- Status last verified
- May 2013
- First submitted
- 23 Oct 2012
- Last updated
- 17 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-blind Placebo Controlled Phase II Study to Evaluate the Efficacy and Safety of Sorafenib Treatment in Patients With Advanced (Recurrent, Persistent and/or Metastasizing) Medullary Thyroid Carcinoma
- ClinicalTrials.gov ID
- NCT01736878
- Acronym / sponsor ID
- SUMMIT / EARL-2
- Conditions
- Medullary Thyroid Carcinoma
- Keywords
- Medullary Thyroid Carcinoma, Sorafenib, Efficacy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was withdrawn due to unanticipated hassle in patient recruitment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Eanm Research LtdResearch network
- Study start
- Oct 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 29 Nov 2012 (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.
The purpose of his study is to evaluate the efficacy and safety of Sorafenib versus placebo in subjects with locally advanced medullary thyroid cancer (MTC). The primary study objective is to compare the Progression-free Survival (PFS) of the Sorafenib treatment group with the placebo treatment group in patients with advanced MTC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sorafenib tablets | Experimental | Drug: SorafenibOral administration of Sorafenib tablets, 400 mg bid, until disease progression or unacceptable toxicity |
| Placebo tablets | Placebo comparator | Drug: SorafenibOral administration of Placebo tablets until disease progression, afterwards continuation with Sorafenib at the discretion of the investigator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Inpatient or outpatient ≥ 18 years of age
- Histologically confirmed medullary thyroid carcinoma
- Recurrent or persistent local disease and/or distant metastases
- No more than one prior line of systemic therapy
- Best available supportive care to control (endocrine) symptoms
Key exclusion criteria (21 listed)
- Unresolved toxicity (i.e. neurotoxicity) attributed to any prior therapy higher than National Cancer Institute-Common Toxicity Criteria for Adverse Effects (NCI-CTCAE version 4) Grade 2 (excluding cases of alopecia)
- Patients with history of allergic or hypersensitivity reaction to study drug or placebo or their excipients
- Current participation in another investigational trial
- Patients with significant cardiovascular disease
- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy other than beta-blockers or digoxin
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 |
|---|---|---|
| Sorafenib | Drug | Placebo tablets, Sorafenib tablets |
Primary outcome
Progression Free Survival (PFS)
Time frame: from the date of randomisation until the date of radiological or biochemical progression or death. An average of 9 months is assumed.
The proportion of patients with PFS in the Sorafenib group and the Placebo group will be compared by log rank test and Kaplan-Meier plot.
1 secondary outcome
Time to Progression (TPP)
Time frame: from the date of randomisation until the date of confirmed radiological or biochemical progression. An average of 9 months is assumed.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Sorafenib in people with Medullary Thyroid Carcinoma, run by Eanm Research Ltd at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 21 exclusion criteria. 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: withdrawn, as of the sponsor's last update on 17 May 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 Germany. 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Progression Free Survival (PFS) (time frame: from the date of randomisation until the date of radiological or biochemical progression or death. An average of 9 months is assumed.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 May 2013.