Pilot study of everolimus in the treatment of advanced malignancies in patients with Peutz-Jeghers syndrome - EVAM

• Conditions: Advanced malignancy of any tumor type, not suitable for surgery at the time of study enter in patients with known Peutz-Jeghers disease (with LKB1 mutation).; MedDRA version: 12.1Level: PTClassification code 10034764Term: Peutz-Jeghers syndrome; MedDRA version: 12.1Level: HLTClassification code 10029111Term: Neoplasms unspecified malignancy and site unspecified NEC; MedDRA version: 12.1Level: LLTClassification code 10034764Term: Peutz-Jeghers syndrome

• Registration Number: EUCTR2010-020451-32-NL
• Lead Sponsor: Academic Medical Center Amsterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Known Peutz-Jeghers disease (with LKB1 mutation)
•Advanced malignancy of any tumor type, not suitable for surgery at the time of study enter
•No concurrent systemic anti cancer treatment
•No prior treatment with m-TOR inhibitor
•Patients with prior malignancies or concurrent second malignancies are eligible
•Prior systemic therapy is permitted with a washout time of at least 4 weeks
•Cytological or histological confirmed carcinoma
•Metastatic or non-resectable disease
•Patients with clinically and/or radiographically documented measurable lesion according to RECIST criteria:
X-ray, physical exam> 20 mm
Spiral CT scan> 10 mm
Non-spiral CT scan > 20 mm
•ECOG/ WHO performance 0-2
•Age > 18 years
•Life expectancy > 3 months
•Adequate renal function (creatinine < 150 µmol/L)
•Adequate liver function (bilirubin < 1.5 times upper limit of normal, ALAT or ASAT < 5.0 times upper limit of normal in case of liver metastases and < 2.5 the upper limit of normal in absence of liver metastases
•Adequate bone marrow function (WBC > 3.0 x 10 9/L, platelets > 100 x 10 9/L)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
•Patients who are pregnant or lactating
•Patients who are of childbearing potential who do not agree to use a reliable contraceptive method throughout the study
•Patients who do have serious concomitant systemic disorder that would compromise the safety of the patient, at the discretion of the investigator
•Patients who are not willing to sign the Signed informed consent according to ICH/GCP, IRB approval obtained prior to treatment
•Patients who do have uncontrolled symptomatic hyperglycaemia

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified