Safety and Biological Activity of C2L-OCT-01 PR in Acromegalic Patients

Phase 3

Terminated

• Conditions: Acromegaly
• Interventions: Drug: C2L-OCT-01 PR, 20 mg; Drug: C2L-OCT-01 PR, 10 or 20 mg

• Registration Number: NCT00642421
• Lead Sponsor: Ambrilia Biopharma, Inc.

Brief Summary

The purpose of this study is to assess the safety profile of a new prolonged release formulation of octreotide acetate, C2L-OCT-01 PR, administered intra muscularly every 4, 5 or 6 weeks in acromegalic patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-03-21
• Study First Submitted QC: 2008-03-21
• Study First Posted: 2008-03-25
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-07
• Last Update Posted: 2010-02-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Population B	C2L-OCT-01 PR, 20 mg	Population B, naive patients and patients who have stopped their treatment with prolonged release octreotide for at least 12 weeks, will receive 20 mg C2L-OCT-01 PR at 5-week intervals.
Population A	C2L-OCT-01 PR, 10 or 20 mg	Based on the dose of their previous Sandostatin-LAR treatment, Population A will receive 10 or 20 mg of C2L-OCT-01 PR at 5-week intervals.

Primary Outcome Measures

Name	Time	Method
To assess the safety profile of a new prolonged release formulation of octreotide acetate, C2L-OCT-01 PR, administered intra muscularly every 4, 5 or 6 weeks in acromegalic patients.	28-day screening period followed by a 48 to 52 week treatment period and concluding with a end of study visit at 56, 57 or 58 weeks.

Secondary Outcome Measures

Name	Time	Method
To assess biological and clinical activity of C2L-OCT-01 PR by examining the percentage of patients with mean growth hormone (GH) <2.5 ng/ml.	Screening, Visits 1 through 11, and End of Study Visit.
To assess the biologic and clinical activity of C2L-OCT-01 PR by examining the mean changes from baseline in GH and IGF-1 concentrations.	Screening, Visits 1 through 11, and End of Study Visit.
To assess the biologic and clinical activity of C2L-OCT-01 PR by examining the acromegaly severity index and patient's health status scores.	Screening, Visit 1 through 11, and End of Study Visit.
To assess biological and clinical activity of C2L-OCT-01 PR by examining the pituitary tumor size.	Screening, Visit 6 and End of Study Visit.

Trial Locations

Locations (10)

The Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

UCLA Medical Center Division of Neurosurgery; 🇺🇸 Los Angeles, California, United States

Stanford University Medical Center; 🇺🇸 Stanford, California, United States

Kaleida Health/Diabetes Center of WNY; 🇺🇸 Buffalo, New York, United States

Republican Centre for Medical Rehabilitation and Water-therapy; 🇧🇾 Minsk, Belarus

Semmelweis Egyetem Altalanos Orvostudomanyi; 🇭🇺 Budapest, Hungary

Institute of Endocrinology "C.I. Parhon" Bucharest; 🇷🇴 Bucharest, Romania

VA Puget Sound Health Care System; 🇺🇸 Tacoma, Washington, United States

Institute of Endocrinology, University Clinical Center; 🇷🇸 Belgrade, Serbia

V.P. Komisarenko Institute of Endocrinology and Metabolism, AMS Ukraine; 🇺🇦 Kiev, Ukraine