OPEN LABEL EXTENSION STUDY EVALUATING THE SAFETY AND BIOLOGICAL ACTIVITY OF A NEW PROLONGED RELEASE FORMULATION OF OCTREOTIDE ACETATE, C2L-OCT-01 PR, ADMINISTERED INTRA MUSCULARLY EVERY 6, 5 0R 4 WEEKS IN ACROMEGALIC PATIENTS

Phase 1

Conditions: Acromegaly
MedDRA version: 9.1Level: LLTClassification code 10000599Term: Acromegaly

Registration Number: EUCTR2007-004320-21-SK

Lead Sponsor: Ambrilia Biopharma Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 61

Inclusion Criteria

• Patients having completed the 24 week study C2L-OCT-01 PR-301 (protocol version 3, 8 May 2007)
•Women of childbearing potential must have a negative pregnancy test.
•Having the ability to understand the requirements of the study, provide written informed consent to participate in this study, and agree to abide by the study restrictions.
Entry criteria for participation in Extension Study Part B:
•Patients having completed the first 6 month study C2L-OCT-01 PR-302 of Part A
•Women of childbearing potential must have a negative urine pregnancy test.
•Patients having the ability to understand the requirements of the study.
•Patients who:
have achieved a mean GH value < 2.5 ng/ml from baseline (Day 1 of study C2L-OCT-01 PR-301)
or:
have a decrease of GH mean value of at least 30% from baseline (Day 1 of study C2L-OCT-01 PR-301) and have an improvement in their clinical symptoms based on investigator’s judgment.

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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Female patients of childbearing potential age who are not using adequate contraception. (i.e. oral or trans-dermal contraceptive drugs, intra-uterine device, diaphragm)
•Pregnant or lactating female patients.
•Having experienced any clinically significant adverse event related to study medication in the C2L-OCT-01 PR-301 (version 3, 8 May 2007).
•Patients with uncontrolled Diabetes type II as indicated by the presence of ketoacidosis or HbA1C = 10%.
•Presenting clinically significant signs and symptoms potentially related to a tumor compression of the optical chiasm, based on judgment of the investigator.
•Patients with symptomatic cholelithiasis.
•Presenting clinically serious and/or unstable intercurrent infection, medical illnesses or conditions that are uncontrolled or whose control, in the opinion of the Investigator, may be jeopardized by participation in this study or by the complications of this therapy.