Phase 3 N=204 Randomized Double-blind Treatment

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

Endocrine Tumors

Bottom Line

View on ClinicalTrials.gov: NCT00353496 ↗

Enrolled (actual)

204

Serious AEs

27.9%

Results posted

Feb 2015

Primary outcome: Primary: Progression-Free Survival (PFS) — NA; 72 Weeks — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: lanreotide (Autogel formulation) (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Ipsen
Primary completion: Apr 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Progression-Free Survival (PFS)	NA; 72	<0.001 sig
SECONDARY Percentage of Patients Alive & Without Disease Progression	66; 49; 53; 25	—
SECONDARY Pharmacokinetic Profile of Lanreotide	2.5; 5.0; 6.1; 6.2; 6.6; 6.8	—
SECONDARY Change in the Global Health Status Quality of Life Assessment	-5.2; -4.9	—
SECONDARY Percentage of Patients With a Greater Than or Equal to 50% Decrease in Plasma Chromogranin A (CgA) Levels	42.2; 4.7	—
SECONDARY Percentage of Patients Still Alive Based on Available Overall Survival Data	84; 77	—

Summary

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00353496). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.