Neoplasms

All Conditions

Nervous System Diseases

Gland and Hormone Related Diseases

Musculoskeletal Diseases

Rare Diseases

Adenoma

Pituitary Diseases

Acromegaly

Pituitary Neoplasms

Gigantism

Bone Diseases

Bone Diseases, Endocrine

Hypothalamic Diseases

Brain Diseases

Central Nervous System Diseases

Endocrine System Diseases

All Drugs and Chemicals

Hematinics

Antineoplastic Agents

Hormones

Liver Extracts

Lanreotide

Somatuline Depot SC 90mg deep subcutaneous injection every 4 weeks for 3 doses before surgery. The dose will be 60 mg for patients with mild liver or kidney dysfunction.

Somatuline Depot 90 mg deep subcutaneous injection every 4 weeks X 3 doses

lanreotide

Daniel F Kelly, MD

If someone is diagnosed with a pituitary tumor that causes acromegaly (too much growth hormone) the treatment is to have it surgically removed. This study has two phases.

The first phase provides medical treatment with a drug that will be provided for 3 months before surgery to see if complications of surgery are reduced and to see whether or not remission improves following surgery if you have this medical treatment. The drug administered is approved by the FDA for long-term treatment of acromegaly. It is not routinely administered before surgery, and is therefore experimental as used in this way. All other procedures performed during this research are standard of care with the exception of the 3 questionnaires to be completed at each visit.

The second phase of this study is from 3 months until 12 months after surgery and is only for people who do not go into remission after the operation. This phase assesses the possible remission of acromegaly after resuming the drug treatment for an additional 3 to 9 months. The drug will be prescribed by your physician as part of your regular medical care and will not be included as part of the study. All other procedures performed during this research are standard of care with the exception of the 3 questionnaires to be completed at each visit.

The study lasts approximately 16 months - 3 month before surgery and 12 months after surgery.

A Pilot Study of Pre- and Post-operative Use of Somatuline Depot.

A Pilot Study of Pre- and Post-operative Somatuline Depot Therapy in Acromegalic Patients Treated by Endonasal Endoscopic Surgery: Impact on Early Remission Rates and Perioperative Morbidity

Remission status one year after surgery and time to achieve remission in patients who did not achieve remission after endonasal endoscopic surgery and who had resumption of Somatuline Depot therapy 3 months after surgery.

Early remission status after a 12 week course of pre-operative Somatuline Depot and 3 months after endonasal endoscopic surgery. Remission status will be based on age-adjusted Insulin Glucose Factor 1 (IGF-1) levels and oral glucose tolerance test.

Changes in cardiac function after 12 weeks of Somatuline therapy and 3 months after endonasal endoscopic adenoma removal.

Change in hypertension after 12 weeks of Somatuline therapy and 3 months after endonasal endoscopic adenoma removal

Change in respiratory function after 12 weeks of Somatuline therapy and 3 months after endonasal endoscopic adenoma removal

Change in Quality of Life after 12 weeks of Somatuline therapy and 3 months after endonasal endoscopic adenoma removal

Saint John's Cancer Institute

Somatuline Depot SC 90mg deep subcutaneous injection every 4 weeks for 3 doses before surgery. The dose will be 60 mg for patients with mild liver or kidney dysfunction.

lanreotide: Somatuline Depot 90 mg deep subcutaneous injection every 4 weeks X 3 doses

Somatuline Depot SC

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Daniel Kelly

Somatuline Depot Subcutaneous (SC)

2 patients treated; data not analyzed because study terminated prematurely.

Early Remission of Acromegaly

Change in Cardiac Function

Change in Hypertension

Change in Respiratory Function

Change in Quality of Life

Remission Status 1 Year After Surgery

Somatuline Depot Subcutaneous (SC) 90mg deep subcutaneous injection every 4 weeks for 3 doses before surgery. The dose will be 60 mg for patients with mild liver or kidney dysfunction.

lanreotide: Somatuline Depot 90 mg deep subcutaneous injection every 4 weeks X 3 doses

Overall Study

Digestive System Diseases

Neuroendocrine Tumors

Endocrine Gland Neoplasms

Adenoma, Islet Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Neuroendocrine Tumor

Pancreatic Neuroendocrine Tumor

Pancreatic Cancer

Somatostatin

Hormone Antagonists

Patients from the preceding DB study (Study 726) were treated with open label lanreotide Autogel 120 mg by deep subcutaneous injections every 28 days. Patients were included if they had been treated with lanreotide (Autogel formulation) or placebo in DB Study 726 and had stable disease at the end of the 96-week treatment period, or if they had received placebo and had disease progression at any time during Study 726. Safety data were based on the safety population patients who received lanreotide in Study 729). The main efficacy analysis was based on the ITT population (patients randomised in Study 726 regardless of whether they continued into Study 729).

lanreotide (Autogel formulation)

Ipsen Medical Director

The primary purpose of this extension study was to assess the long term safety of patients with nonfunctioning enteropancreatic neuroendocrine tumour (NET), who were treated with open label lanreotide Autogel (120 mg every 28 days) and who participated in a previous study, 2-55-52030-726 (NCT00353496).

While somatostatin analogue treatment is the primary medical therapy for patients with hormone related symptoms and is indicated for the treatment of hormone related symptoms in many international countries, there is no reference standard medical therapy for asymptomatic patients. A 96-week study (Study 2-55-52030-726 (726), NCT00353496) was conducted to investigate the effect of lanreotide Autogel on progression free survival (PFS) in patients with well or moderately differentiated nonfunctioning enteropancreatic NET. While Study 726 was ongoing, the sponsor considered that therapy with lanreotide Autogel should continue to be an option to patients with stable disease at the end of the 96-week treatment period. This extension study was therefore initiated (Study 2-55-52030-729 (729)) which investigated the long term safety of treatment with lanreotide Autogel and enabled investigators to continue to treat their patients who had stable disease, as well as to treat placebo patients who experienced disease progression during the initial 96-week study (Study 726).

Study of Lanreotide Autogel 120 mg in Patients With Non-functioning Entero- Pancreatic Endocrine Tumour

Open Label Extension Study of Lanreotide Autogel 120 mg in Patients With Non-functioning Entero-pancreatic Endocrine Tumour

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of study participants.

Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.

Adverse events (AEs) that were ongoing from Study 726 at the time of entry into Study 729 were transcribed into the case report form (CRF) for Study 729 with a start date corresponding to the original report of this AE in Study 726. All new AEs that started after the last visit in Study 726 (i.e. irrespective of whether the AE had onset before or after giving informed consent for Study 729) were recorded Study 729.

An AE was considered as a treatment emergent adverse event (TEAE) for Study 729 if:

* It was not present prior to receiving the first dose of study treatment in Study 729; or,
* It was present prior to receiving the first dose of study treatment in Study 729 but the intensity increased after the first dose of study treatment in Study 729.

Adverse event data are presented in the AE section.

The time from randomisation in Study 726 to the first occurrence of either disease progression (measured using Response Evaluation Criteria In Solid Tumours \[RECIST\] criteria) or death in Study 726 or in Study 729, or equivalently, the Progression Free Survival (PFS) time.

Tumour assessments for the placebo group after switching to open label lanreotide Autogel were excluded for the purpose of this analysis. Estimation of the median was based on the Kaplan-Meier method.

Ipsen

Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. Local tolerance AEs were assessed by spontaneous reports. Any local tolerance assessed as present and judged as clinically significant was recorded as an AE in the CRF. Pre-existing conditions that worsened during the study were reported as AEs. Adverse events that were ongoing at the end of Study 726 were recorded and followed during Study 729.

Patients who received lanreotide 120 mg (Autogel formulation) in the preceding DB study (Study 2-55-52030-726) and who continued to receive lanreotide 120 mg (Autogel formulation) in the open label study.

Lanreotide Autogel

Patients who received placebo in the preceding DB study (Study 2-55-52030-726) and who received lanreotide 120 mg (Autogel formulation) in the open label study.

Placebo

All patients treated with lanreotide 120 mg (Autogel formulation) in the open label study.

Total

Age, Continuous

Asian

Black or African American

Caucasian/White

Race/Ethnicity, Customized

Safety Population: All patients who received at least one dose of lanreotide Autogel in Study 729.

Medical Director, Oncology

Patients who received placebo in the preceding double DB study (Study 2-55-52030-726) and who received lanreotide 120 mg (Autogel formulation) in the open label study.

All patients treated with Lanreotide 120 mg (Autogel formulation) in the open label study.

Safety population: all patients who received at least one dose of lanreotide Autogel in Study 729.

Adverse Events

All patients randomised to lanreotide 120 mg (Autogel formulation) in the original protocol Study 726 (regardless of whether they continued into the extension Study 729).

Lanreotide Autogel - Randomised Treatment in Study 726

All patients randomised to placebo in the original protocol Study 726 (regardless of whether they continued into the extension Study 729).

Placebo - Randomised Treatment in Study 726

Intention-to-treat (ITT) population: all patients randomised in the original protocol Study 726 (regardless of whether they continued into the extension Study 729). The ITT population was analysed using patients as randomised in Study 726.

Progression Free Survival (PFS): Kaplan-Meier Estimate

Patients who received lanreotide 120 mg (Autogel formulation) in the preceding double blind (DB) study (Study 2-55-52030-726) and who continued to receive lanreotide 120 mg (Autogel formulation) in the open label study.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Pilot Study of Pre- and Post-operative Use of Somatuline Depot.	NCT01861717	Acromegaly	lanreotide	18 Years - 75 Years	Saint John's Cancer Institute
Study of Lanreotide Autogel 120 mg in Patients With Non-functioning Entero- Pancreatic Endocrine Tumour	NCT00842348	Non Functioning...	lanreotide (Aut...	18 Years -	Ipsen

Spots Global Cancer Trial Database for somatuline

Every month we try and update this database with for somatuline cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for somatuline

Every month we try and update this database with for somatuline cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for somatuline cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.