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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Endocrine Tumors

Thank you

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 IowaIowa City, Iowa  52242
MD Anderson Cancer CenterHouston, Texas  77030-4096
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Providence Portland Medical CenterPortland, Oregon  97213-3635
Ceders-Sinai Outpatient Cancer CenterLos Angeles, California  90048
The John Hopkins HospitalBaltimore, Maryland  21287-4606
University of Wisconsin School of Medicine and Public HealthMadison, Wisconsin  53792-5666