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
18 Years
N/A
Both
Endocrine Tumors
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Time to either disease progression or death
Outcome Time Frame:
Within 96 weeks after the first study drug administration
Safety Issue:
No
Principal Investigator
Joelle Blumberg, MD
Investigator Role:
Study Director
Investigator Affiliation:
Ipsen
Authority:
United States: Food and Drug Administration
Study ID:
2-55-52030-726
NCT ID:
NCT00353496
Start Date:
June 2006
Completion Date:
June 2013
Related Keywords:
- Endocrine Tumors
- Non functioning entero-pancreatic tumours
- Endocrine Gland Neoplasms
- Adenoma, Islet Cell
Name | Location |
|---|---|
| University of Iowa | Iowa City, Iowa 52242 |
| MD Anderson Cancer Center | Houston, Texas 77030-4096 |
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| Providence Portland Medical Center | Portland, Oregon 97213-3635 |
| Ceders-Sinai Outpatient Cancer Center | Los Angeles, California 90048 |
| The John Hopkins Hospital | Baltimore, Maryland 21287-4606 |
| University of Wisconsin School of Medicine and Public Health | Madison, Wisconsin 53792-5666 |
