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Medullary Thyroid CancerPhase 2NCT01625520

SOM230 Alone or in Combination With RAD001 in Patients With Medullary Thyroid Cancer

A Phase 2 study testing SOM230 alone or in combination with RAD001. in people with Medullary Thyroid Cancer, run by Federico II University at 1 site in Italy.

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

A mono centre study to evaluate the efficacy of SOM230 in patients with progressive metastatic or postoperative persistent medullary thyroid cancer. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Medullary Thyroid Cancer
What is being tested?
SOM230 alone or in combination with RAD001.
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteItaly
Study dates
Feb 2012to Mar 2016
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with progressive metastatic or postoperative persistent medullary thyroid cancer who have histopathologically confirmed disease and measurable tumor lesions. (Postoperative persistent after surgical removal is characterized by increased levels of calcitonin with or without radiological detectable tumour relapse or metastases.)
  • Patients with evidence of biochemical progression of disease, as expressed by progressive increase of serum calcitonin levels, assessed once a month for at least three months before study entry, according to RECIST definitions (elevation of the markers for at least 25 %).
  • Disease that is not amenable to surgery, radiation, or combined modality therapy with curative intent.
  • Adequate organ function - Karnofsky-Index performance status >60%
  • Life expectancy > 6 months
  • Age > 18 years
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  • Women of childbearing potential must have a negative serum pregnancy test within 14 days of randomization and a urine pregnancy test 48 hours prior to the administration of the first study treatment.
  • Patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout the trial and adjusted as necessary.
  • Signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial prior to enrolment.

Who cannot join

  • Unstable systemic diseases including uncontrolled hypertension, active uncontrolled infections, psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.
  • Known hypersensitivity to somatostatin analogues.
  • Pregnant or breast-feeding patients
  • Sign of recurrence of prior or concomitant malignancies (within the last 3 years or requiring active treatment) other than MTC; with the exception of previous basal cell skin cancer, previous cervical carcinoma in situ
  • Prior therapy with mTOR inhibitors (e.g. sirolimus, temsirolimus, everolimus)
  • Participation in a clinical trial to test an investigational drug within 4 weeks prior to visit 1.
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  • Any of severe and/or uncontrolled medical conditions:
  • Patients who have congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, ventricular fibrillation, clinically significant bradycardia, advanced heart block or a history of acute myocardial infarction within the six months preceding enrollment,
  • QT related exclusion criteria
  • Previous treatments with chemotherapy, loco regional therapy (eg, chemoembolization) or interferon are permitted providing that toxicity has resolved to < Grade 1 at study entry and that last treatment was at least 4 weeks prior to baseline assessment.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Department of Molecular and Clinical Endocrinology and Oncology, "Federico II" University of Naples

    Naples, Italy, 80131

Other trials in Italy

About this study

Official title: Mono Centre, Open Label Proof of Concept Study SOM230 in Progressive Medullary Thyroid Cancer Patients and the Combination With RAD001 Upon Progression

A mono centre study to evaluate the efficacy of SOM230 in patients with progressive metastatic or postoperative persistent medullary thyroid cancer.

Read the detailed description

Medullary thyroid cancer (MTC) is a neuroendocrine tumor originating from thyroid C cells. Neuroendocrine tumors have been demonstrated to express somatostatin receptors as well as mTOR pathway. The somatostatin analogues now available (octreotide and lanreotide) act preferentially through the somatostatin receptor subtype 2 (sst2). In MTC, these compounds have been reported to exert anti-secretive effects on calcitonin but no anti-proliferative effects.SOM230 (pasireotide) is a new somatostatin analogue showing a peculiar binding profile with high affinity for sst1, sst2, sst3, sst5. Preliminary data show SOM230 to be effective in a phase II study on patients with metastatic carcinoid. RAD001 (everolimus) is a novel agent that interacts with mTOR. It was demonstrated to inhibit tumor growth in neuroendocrine tumor cell lines. Some clinical trials have explored the efficacy of a combined therapy with RAD001 plus octreotide in patients with digestive neuroendocrine tumors, highlighting encouraging results in term of tumor control.In particular, octreotide and RAD001 seem to show a synergistic activity in inhibiting neuroendocrine tumor proliferation.

Being tested
SOM230 alone or in combination with RAD001.
Keywords
Progressive metastatic, postoperative persistent
Medical subject headings
Carcinoma, Medullary

What participants receive

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

  • SOM230 alone or in combination with RAD001.Drug

    SOM230 (pasireotide) 60 mg i.m. injection once every 28 days, +/- 2 days. RAD001 (everolimus) 10 mg per os daily.

Study groups in NCT01625520
Study groupRoleWhat they receive
SOM230 alone or in combination with RAD001ExperimentalPatients with progressive metastatic or postoperative persistent medullary thyroid cancer will start the study treatment as a mono therapy with SOM230. Patients benefiting from the treatment will continue with the monotherapy (stable disease or better according to RECIST). Patients progressing will be switched to the combination therapy with SOM230 and RAD001.
Receives: Drug: SOM230 alone or in combination with RAD001.

What is being measured

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

  1. Efficacy of SOM230 in patients with progressive metastatic or postoperative persistent medullary thyroid cancer

    Efficacy is defined as progression-free survival (PFS), according to RECIST criteria, in patients treated with SOM230.

    Measured: From date of start therapy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months.

Secondary outcomes (7)

  1. Efficacy of SOM230 in combination with RAD001 in patients with progressive metastatic or postoperative persistent medullary thyroid cancer.

    Efficacy is defined as progression-free survival (PFS), according to RECIST criteria, in patients treated with SOM230 in combination with RAD001.

    Measured: From date of start therapy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months.

  2. Biochemical response

    Biochemical response is defined as the change of calcitonin and carcinoembryonic antigen (CEA) serum concentrations recorded from date of study entry until disease progression compared to baseline. Time-to-biochemical-response is defined as the time from start of the study treatment to first documentation of biochemical response of calcitonin and CEA concentrations, respectively. Duration of biochemical response is defined as the time from the first documentation of biochemical response to the first documentation of biochemical progression or to death due to any cause, whichever occurs first.

    Measured: From date of start therapy, 1 month, 2 month, 3 month, 6 month time point evaluation, up to 6 months.

  3. Objective tumor response

    Objective tumor response (OR) are the overall responses recorded from date of study entry until end of study/study exclusion, according to RECIST definitions, confirmed by repeat measurements. OR includes complete remission (CR), partial (PR), stable disease (SD) and progressive disease (PD) of all measurable tumor lesions of all evaluable patients.

    Measured: From date of start therapy, 3 month, 6 month time point evaluation, up to 6 months.

  4. Overall survival

    Measured: From date of start therapy to the end of the study or death from any cause, whichever came first, up to 6 months.

  5. Time to response

    Time to response is defined as the time from start of treatment to the first objective tumor response (PR or CR) observed. Patients who did not achieve a confirmed PR or CR will be censored at last adequate tumor assessment date when they did not progress (including deaths not due to underlying disease)

    Measured: From date of start therapy, 3 month, 6 month time point evaluation, up to 6 months.

  6. Duration of response

    Duration of response is defined as the time from onset of response (CR/PR) to objective tumor progression or death from any cause. Patients not experiencing progression or death will be censored with the date of their last adequate tumor assessment.

    Measured: From time of response to time of tumor progression or death from any cause, whichever came first.

  7. Safety

    Safety will be evaluated using assessment of adverse events and laboratory data. The assessment of safety will be based on the frequency of adverse events and on the number of laboratory values that are new or worsening based on the common toxicity criteria (CTC) grade. Other safety data (e.g. vital signs) will be considered appropriately.

    Measured: From date of start therapy until the end of the study, every 30 days, up to 6 months.

Timeline

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

  1. First posted21 Jun 2012 (estimated)
  2. Study startFeb 2012
  3. Primary completionMar 2016

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01625520
Sponsor's protocol ID
2010-023128-26
Status last verified
Apr 2016
First submitted
25 May 2012
Last updated
25 Apr 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Faggiano A, Modica R, Severino R, Camera L, Fonti R, Del Prete M, Chiofalo MG, Aria M, Ferolla P, Vitale G, Pezzullo L, Colao A. The antiproliferative effect of pasireotide LAR alone and in combination with everolimus in patients with medullary thyroid cancer: a single-center, open-label, phase II, proof-of-concept study. Endocrine. 2018 Oct;62(1):46-56. doi: 10.1007/s12020-018-1583-7. Epub 2018 Mar 23.

    PubMed 29572709

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SOM230 alone or in combination with RAD001. in people with Medullary Thyroid Cancer, run by Federico II University at 1 site in Italy.

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 9 inclusion and 10 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: finished, as of the sponsor's last update on 25 Apr 2016. 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 Italy. 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?

Efficacy of SOM230 in patients with progressive metastatic or postoperative persistent medullary thyroid cancer (time frame: From date of start therapy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months.). 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 NCT01625520, 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 25 Apr 2016.

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