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

NCT01625520 | Completed Phase 2 DMC

• 1 other identifier: 2010-023128-26
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Medullary Thyroid Cancer

Keywords

Progressive metastatic; postoperative persistent

Outcome Measures

Primary Outcomes (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.

  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)

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

  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.

• Biochemical response

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

• Objective tumor response

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

• Overall survival

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

• Time to response

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

Study Arms (1)

SOM230 alone or in combination with RAD001

EXPERIMENTAL

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.

Drug: SOM230 alone or in combination with RAD001.

Interventions

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.

SOM230 alone or in combination with RAD001

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,
• 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.

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

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

Naples, Italy, 80131, Italy

Location

Related Publications (1)

• 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.

  PMID: 29572709 DERIVED

MeSH Terms

Conditions

Carcinoma, Medullary

Interventions

pasireotide; Everolimus

Condition Hierarchy (Ancestors)

Carcinoma, Neuroendocrine; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Study Officials

• Annamaria Colao

  "Federico II" University of Naples, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 25, 2012
• First Posted: June 21, 2012
• Study Start: February 1, 2012
• Primary Completion: March 1, 2016
• Last Updated: April 25, 2016

Record last verified: 2016-04

Locations

IT (1)