A EUROPEAN, MULTICENTRE, PHASE II/III RANDOMISED DOUBLE-BLIND, PLACEBO CONTROLLED STUDY EVALUATING LANREOTIDE AS MAINTENANCE THERAPY IN PATIENTS WITH NON-RESECTABLE DUODENO-PANCREATIC NEUROENDOCRINE TUMOURS AFTER FIRST-LINE TREATMENT
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Enrollment
- 53
- Locations
- 24
- Primary Endpoint
- Proportion of Patients Alive and Progression-free at 6 Months
Study Overview
Brief Summary
This European, prospective, multicentre, double-blind randomised study will evaluate the effect of lanreotide (120 mg every 28 days until disease progression) versus placebo in patients with metastatic/locally advanced, non-resectable, duodeno-pancreatic neuroendocrine tumours.
Detailed Description
This is a European, prospective, multicentre, double-blind randomised study evaluating lanreotide (120 mg every 28 days until disease progression) versus placebo in patients with metastatic/locally advanced, non-resectable, duodeno-pancreatic neuroendocrine tumours.
Depending on the phase II results, the study may be continued into phase III. The treatment and follow-up of patients will be the same in phase II and phase III.
After the first-line treatment, patients will be randomly assigned with a 1:1 ratio to receive either lanreotide or placebo. The study treatment should be initiated within 6 weeks following the confirmation date of stable disease or objective response.
Treatment period:
For each patient, the investigational products (lanreotide or placebo) will be provided according to a double-blind procedure until disease progression or toxicity, in accordance with the protocol.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Metastatic (synchronous or metachronous) or locally advanced, non-resectable, well-differentiated duodeno-pancreatic neuroendocrine tumour, of grade 1 or 2 (WHO 2010 classification; Ki-67 ≤ 20%)
- •Progressive before first-line treatment
- •Histologically confirmed (either on primary tumour or metastases)
- •Pathological diagnosis validated by the NET consulting pathologist
- •Documented stable disease or objective response after first-line treatment, within 4 weeks (28 days) prior to randomisation
- •The first-line treatment will consist of either a chemotherapy or biotherapy (everolimus or sunitinib) as referred to TNCD or ENETS guidelines. Treatment must have been administered for 3 to 6 months for chemotherapy and for 6 months for biotherapy
- •Non-functional tumour or gastrinoma controlled by PPIs
- •Age > or = 18 years
- •WHO 0, 1 or 2
- •Effective contraception for male or female patients of childbearing age, defined as: oral contraceptives, intra-uterine devices, barrier contraceptive methods along with a spermicide gel, or surgical sterilisation. Female patients should use this contraception throughout the treatment period and for 6 months after the last treatment administration. Male patients should use contraception throughout the treatment period and for 3 months after the last treatment administration.
- •Signed informed consent prior to initiation of any study-specific procedures or treatment.
Exclusion Criteria
- •History of haematological malignancy or other cancer, except those treated for more than 5 years and considered as cured, carcinoma in situ of the cervix and treated skin cancer (excluding melanoma)
- •Poorly differentiated neuroendocrine carcinoma or NET grade 3 ENETS (Ki-67 > 20%)
- •If primary resected, bone metastasis exclusively
- •Pre-treatment by somatostatin long-acting analogue
- •Total bilirubin ≥ 60 µmol/L
- •Uncontrolled diabetes
- •Contraindication to product used in the study or its components
- •Tumour arising in the context of a genetic disease
- •Pregnancy or lactation
- •Patients unable to undergo medical follow-up due to geographical, social, psychological or legal reasons
- •Concomitant participation in another clinical trial investigating a treatment during the treatment phase and within 30 days prior to the start of the study treatment.
Arms & Interventions
lanreotide
In this arm, patients will receive lanreotide 120 mg every 28 days until disease progression
Intervention: lanreotide (Drug)
placebo
In this arm, patients will receive placebo every 28 days until disease progression
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Proportion of Patients Alive and Progression-free at 6 Months
Time Frame: 6 months
The primary endpoint for this phase II study was the proportion of pts alive and progression-free at 6 months after randomisation, evaluated according to the results of the imaging assessment done by the investigator in line with RECIST 1.1 criteria.
Secondary Outcomes
- Progression-Free Survival(up to 2 years)
- Overall Survival(2 years after the end of the treatment)