Phase 3
Completed N=204
Study of Lanreotide Autogel in Non-functioning Entero-pancreatic Endocrine Tumours
Endocrine Tumors
Source: ClinicalTrials.gov NCT00353496 ↗
Enrolled (actual)
204
Serious AEs
27.9%
Results posted
Feb 2015
Primary outcomePrimary: Progression-Free Survival (PFS) — NA; 72 Weeks — p=<0.001
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.
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 | — |
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
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. Informational only — not medical advice.