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Trial · Interventional

CompletedPhase 2Registry data

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

NCTNCT01625520 (opens ClinicalTrials.gov in a new tab)Other id2010-023128-26
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Names Pasireotide, does not test it. It appears in the summary.

Overview

Status
Completed
Phase
Phase 2
Enrollment
19 participants (actual)
Sponsor
Federico II University · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

Italy

Start
Feb 2012
Primary completion
Mar 2016
Completion
Not stated
First posted
21 Jun 2012 (estimated)
Last update posted
25 Apr 2016 (estimated)
Conditions
Medullary Thyroid Cancer

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201220132014201520162017
  1. Ph 2

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

    NCT01625520

    Feb 2012 to Mar 2016 (primary)

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • SOM230 alone or in combination with RAD001.Drug

Arms1

  • Experimental

    SOM230 alone or in combination with RAD001

    Patients 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 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.

    Registry description

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

Secondary outcomes(7)

  1. Efficacy of SOM230 in combination with RAD001 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.

    Registry description

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

  2. Biochemical response

    Time frame · From date of start therapy, 1 month, 2 month, 3 month, 6 month time point evaluation, up to 6 months.

    Registry description

    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.

  3. Objective tumor response

    Time frame · From date of start therapy, 3 month, 6 month time point evaluation, up to 6 months.

    Registry description

    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.

  4. Overall survival

    Time frame · 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 frame · From date of start therapy, 3 month, 6 month time point evaluation, up to 6 months.

    Registry description

    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)

  6. Duration of response

    Time frame · From time of response to time of tumor progression or death from any cause, whichever came first.

    Registry description

    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.

  7. Safety

    Time frame · From date of start therapy until the end of the study, every 30 days, up to 6 months.

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

PubMed tag: none · 2018

4 results

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.

Faggiano et al. 2018Endocrinecited by 20

PMID 29572709DOI 10.1007/s12020-018-1583-7PUB-29572709

Rights unknown4 results
Source linkSee results (4)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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 * 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. Exclusion Criteria: * 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. * 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.

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