An open label, multicenter, single arm study of pasireotide LAR in patients with rare tumors of neuroendocrine origin - NA

Phase 1

Conditions: The following tumors are included:1. NETs of the pancreas or duodenum: Insulinoma, Gastrinoma, VIPoma, glucagonoma,2. Pituitary NETs: Thyrotropic-pituitary adenoma (TSH), Gonadotropic adenoma, Prolactinoma (PRL) and non-functioning pituitary adenoma (NFPA)3. Ectopic ACTH-secreting (EAS) tumors4. Nelson's syndrome
MedDRA version: 14.1Level: LLTClassification code 10062476Term: Neuroendocrine tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Registration Number: EUCTR2008-007348-32-DE

Lead Sponsor: ovartis Pharma Services AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 120

Inclusion Criteria

1. Male or female patients ?18 years.
2. Patients who have failed standard of care treatment or for whom no standard of care treatment is available.
3. Patients with rare neuroendocrine tumors of pancreas or duodenum must meet each of the following:
? Pathologic confirmation: Patients must have histologically or cytologically confirmed low or intermediate grade neuroendocrine carcinoma. Patients with poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, or goblet cell carcinoid are not eligible. If the pathology report states only neuroendocrine carcinoma, then the pathology subtype must be reconfirmed.
? Advanced metastatic or unresectable disease
? Patients must have biochemical evidence of hormone production and clinical symptoms consistent with diagnosis Insulinoma, Gastrinoma, VIPoma or Glucagonoma. Biochemical evidence can include values of a historical nature: (1) values used to establish the original diagnosis and/or (2) most recently available abnormal value(s).
4. Patients with rare neuroendocrine tumors of pituitary must meet each of the following:
? MRI documenting the presence of a pituitary tumor
? Patients must have biochemical evidence of hormone production (and clinical symptoms consistent with diagnosis of TSH-secreting, gonadotropic secreting, prolacting secreting or non-functioning pituitary adenoma. Biochemical evidence can include values of a historical nature: (1) values used to establish the original diagnosis and/or (2) most recently available abnormal value(s).
5. Patient with EAS tumors and Nelson?s syndrome should have confirmed diagnosis by the investigator with criteria consistent with [Post Text Supplement 1]. Biochemical evidence can include values of a historical nature: (1) values used to establish the original diagnosis and/or (2) most recently available abnormal value(s).
6. ECOG performance status ? 2.
7. Patients must observe the following intervals between the last injection of their previous treatment and the first injection of study drug:
? Octreotide LAR = 28 days (4 weeks)
? Octreotide s.c. = 8 hours
? Lanreotide Autogel = 28 days (4 weeks)
? Lanreotide SR = 14 days (2 weeks)
8. Written informed consent obtained prior to any screening procedures.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patients with active gallbladder disease.
2. Patients with any ongoing or planned anti-neoplastic therapy.
3. Patients with any ongoing or planned therapy with interferon.
4. Poorly controlled diabetes mellitus as indicated by the presence of HbA1c > 8% (Not applicable for glucagonoma patients).
5. Patients with radiolabelled somatostatin analogue therapy within 6 months of visit 1, cytotoxic therapy or interferon within 2 months of visit 1 or radiotherapy within 1 month of visit 1.
6. Patients who have any current or prior medical condition that may interfere with the conduct of the study or the evaluation of its results in the opinion of the Investigator or the Sponsor?s Medical Monitor.
7. Any of the following cardiac abnormalities:
? QTcF at screening > 450 msec
? History of syncope or family history of idiopathic sudden death
? Sustained or clinically significant cardiac arrhythmias
? Risk factors for Torsades de Pointes such as hypokalemia, hypomagnesemia, cardiac failure, clinically significant/symptomatic bradycardia, or high-grade AV block
? Concomitant disease(s) that could prolong QT such as autonomic neuropathy (caused by diabetes, or Parkinson's disease), HIV, cirrhosis, uncontrolled hypothyroidism or cardiac failure
? Concomitant medication(s) known to increase the QT interval
8. Any of the following hepatic related exclusion criteria:
• History of liver disease, such as cirrhosis or chronic active hepatitis B and C
• Presence of Hepatitis B surface antigen (HbsAg)
• Presence of Hepatitis C antibody (anti-HCV)
• History of, or current alcohol misuse/abuse within the past 12 months
• Known gallbladder or bile duct disease, acute or chronic pancreatitis
• Baseline ALT or AST > 3 x ULN
• Baseline total bilirubin > 1.5x ULN
9. Patients with abnormal coagulation (PT or APTT elevated by 30% above normal limits)
10. Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method for birth control.
? Female patients of child-bearing potential must use barrier contraception with condoms. The use of intra uterine device for all women and oral contraception for all women is allowed except for those patients diagnosed with non-functioning pituitary adenoma and gonadotroph adenoma.
? If oral contraception is used in addition to condoms, the patient must have been practicing this method for at least two months prior to enrollment and must agree to continue the oral contraceptive throughout the course of the study, and for three months after the study has ended.
? Male patients who are sexually active are required to use condoms during the study and for three months afterwards as a precautionary measure (available data do not suggest any increased reproductive risk with the study drugs). Female partners of these male patients must use a secondary barrier contraception.
11. Patients who have participated in any clinical investigation with an investigational drug within 30 days prior to dosing.
12. Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will be unable to complete the entire study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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