WithdrawnPhase 2

Study of Everolimus in the Treatment of Advanced Malignancies in Patients With Peutz-Jeghers Syndrome

Stopped: No patients

Netherlands0Started 2010-10

Plain-language summary

In this pilot study the investigators will treat all patients known with Peutz-Jeghers syndrome (PJS) who are diagnosed with advanced malignancies with everolimus 10mg daily until disease progression. Most patients with PJS have an inherited LKB1 mutation leading to aberrant m-TOR activity. Their risk to develop malignancies or intestinal polyps is probably related to this constitutive mTOR signaling. The hypothesis is that mTOR inhibition is an effective anticancer treatment in PJS patients with advanced malignancies.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Known Peutz-Jeghers disease (with LKB1 mutation)
✓. No concurrent systemic anti cancer treatment
✓. No prior treatment with m-TOR inhibitor
✓. Prior malignancies or concurrent second malignancies are allowed
✓. Prior systemic therapy is permitted with a washout time of at least 4 weeks
✓. ECOG/ WHO performance 0-2
✓. Age \> 18 years
✓. Adequate renal function (defined as creatinine \< 150 μmol/L)

What they're measuring

To determine the response rate of Everolimus in patients with advanced cancer and PJS.

Timeframe: During treatment, expected avarage of 12 months

Trial details

NCT IDNCT01178151

SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-04

View on ClinicalTrials.gov More Peutz-Jeghers Syndrome trials