NL-OMON36695CompletedPhase 2
Pilot study of everolimus in the treatment of advanced malignancies in patients with Peutz-Jeghers syndrome - EVAMP
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Academisch Medisch Centrum
- Enrollment
- 15
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •Two cohorts of PJS patients will be included.
- •Cohort 1: Advanced malignancy
- •Cohort 2: High risk polyps
- •*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
- •*Prior malignancies or concurrent second malignancies are allowed
- •*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 (defined as creatinine < 150 *mol/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) E.
- •Specific inclusion criteria for cohort 1:
- •1. Cytological or histological confirmed carcinoma
- •2. Metastatic or non-resectable disease
- •3. Patients with clinically and/or radiographically documented measurable lesion according to
- •RECIST criteria:
- •a. X-ray, physical exam > 20 mm
- •b. Spiral CT scan > 10 mm
- •c. Non-spiral CT scan > 20 mm
- •Specific inclusion criteria for cohort 2:
- •1. Known high risk polyps (definition see page 19)
- •2. Ability to undergo endoscopies
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
- •* Symptomatic PJ-polyps, defined as polyps likely to be responsible/causal for the abdominal
- •symptoms the patient presents with.
Investigators
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