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Completed

NCT Number: NCT00353496

Study of Lanreotide Autogel in Non-functioning Entero-pancreatic Endocrine Tumours

The study will compare the difference between lanreotide Autogel and placebo on progression free survival in patients who have an endocrine tumour in the pancreas or intestines.

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Key information

Conditions

Endocrine Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Hospital, Vienna, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Endocrine tumour in the intestine or pancreas and with locally advanced or metastatic disease
  • No hormone related symptoms
  • Well or moderately differentiated tumour confirmed by histology
  • Tumour lesions which are measurable by a CT or MRI scan

Exclusion criteria

  • Previously treated with a somatostatin analogue unless more than 6 months ago and given for no more than 15 days
  • Treated within the last 6 months with interferon, chemoembolisation or chemotherapy or at any time with a radionuclide
  • Had a previous cancer except basal cell carcinoma and/or in situ carcinoma of the cervix/uterus and/or patients treated with curative intent and free from disease for 5 years
  • Pregnant or lactating
  • Females must use adequate contraception during the study

Treatment and study plan

Lanreotide (Autogel formulation)

Drug

120mg administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.

Placebo

Drug

Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.

Primary outcomes

  1. Progression-Free Survival (PFS)

    Time frame: From randomisation up to the last tumour assessment (scheduled at 96 weeks). Radiological scans were performed every 12 weeks during the first year and every 24 weeks during the second year

    Time from randomization to first documentation of disease progression, or death. Disease progression centrally assessed using Response Evaluation Criteria in Solid Tumours (RECIST) v1.0

Secondary outcomes

  1. Percentage of Patients Alive & Without Disease Progression

    Time frame: Week 48 & 96

    Percentage of patients still ongoing (or completing at Week 96) without centrally assessed disease progression or death at Weeks 48 and 96.

  2. Pharmacokinetic Profile of Lanreotide

    Time frame: Week 4, 12, 24, 36, 48, 72, 96

    Pharmacokinetic Profile of Lanreotide assessed by mean serum concentration at specified timepoints

  3. Change in the Global Health Status Quality of Life Assessment

    Time frame: Week 12 to Week 96 (last visit)

    Transformed scores from European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire responses (QLQ)-C30. Questionnaire response scores range from 0 to 100. Higher scores indicate best possible Quality of Life.

  4. Percentage of Patients With a Greater Than or Equal to 50% Decrease in Plasma Chromogranin A (CgA) Levels

    Time frame: Week 12 to Week 96 (last visit)

  5. Percentage of Patients Still Alive Based on Available Overall Survival Data

    Time frame: Randomisation to death or last visit, up to 321 weeks

    Overall survival defined as the time from randomisation to death due to any cause. Subjects were followed for overall survival beyond study completion/withdrawal via annual telephone contact until the last subject completed the study.

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

Phase III, Randomised, Double-blind, Stratified Comparative, Placebo Controlled, Parallel Group, Multi-centre Study to Assess the Effect of Deep Subcutaneous Injections of Lanreotide Autogel 120mg Administered Every 28 Days on Tumour Progression Free Survival in Patients With Non-functioning Entero-pancreatic Endocrine Tumour

Acronym: CLARINET

Important dates

Study start
2006
Primary completion
2013
Study completion
2013
First posted
Jul 18, 2006
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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