Efficacy and Safety of C2L-OCT-01 PR in Acromegalic Patients

Open Label, Randomized Study Comparing the Biological Efficacy & Safety of a New Prolonged Release Formulation of Octreotide Acetate, C2L-OCT-01 PR, 30 mg Administered Every 42 Days for 84 Days With Sandostatin LAR 30 mg Administered Every 28 Days for 84 Days to Acromegalic Patients

The purpose of this study is to assess the biological safety and efficacy of using the drug, C2L-OCT-01 PR, 30 mg to treat acromegalic patients.

Study Overview

• Status: Completed
• Conditions: Acromegaly
• Intervention / Treatment: Drug: C2L-OCT-01 PR, 30 mg; Drug: Octreotide acetate prolonged release, 30 mg

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belarus
  • Minsk, Belarus
    • Republican Centre for Medical Rehabilitation and Water-therapy
• Hungary
  • Budapest, Hungary
    • Semmelweis Egyetem Altalanos Orvostudomanyi
• Romania
  • Bucharest, Romania
    • Institute of Endocrinology "C. I. Parhon" Bucharest
• Serbia
  • Belgrade, Serbia
    • Institute of Endocrinology, University Clinical Center
• Slovakia
  • Bratislava, Slovakia
    • Fakultná Nemocnica s Poliklinkou Bratislava
• Ukraine
  • Kiev, Ukraine
    • V.P. Komisarenko Institute of Endocrinology and Metabolism, AMS Ukraine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject must be diagnosed with active acromegaly.
• If subject is treated with a long acting somatostatin analogue, the treatment must have been unchanged for a period of at least 12 weeks prior to entry.
• If subject is treated with a 30 mg dose of a depot formulation of a somatostatin analogue, the IGF-1 levels must be normal at entry.
• If subject is treated with a 20 mg dose of a depot formulation of a somatostatin analogue, any value of IGF-1 is acceptable.
• If the subject is receiving an immediate release formulation of a somatostatin analogue or a dopamine agonist, the IGF-1 values must be above 10% of the reference range based on gender and age.
• If the subject is receiving a dopamine agonist, it must be stopped 14 days prior to receiving the study medication.
• The subject should be able to understand the instructions, provide a written consent and abide by the study restrictions.

Exclusion Criteria:

• Women of childbearing potential who are not taking adequate contraception or who are pregnant or lactating.
• Subjects previously treated with a growth hormone receptor antagonist (Pegvisomant) within 12 weeks of study entry.
• Subjects who have undergone pituitary surgery within 6 months or radiotherapy within 2 years prior to admission into the study
• Subjects who present some form of intolerance or allergy to the test article or one of its non-active ingredients
• Subject who have any other condition that alters the growth hormone or IGF-1 levels.
• Subjects with signs or symptoms related to a tumor compression of the optical chiasm.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: B	Drug: Octreotide acetate prolonged release, 30 mg; Administered by deep IM (gluteus) on Days 1, 28 and 56; Other Names: Sandostatin LAR, 30 mg
Experimental: A	Drug: C2L-OCT-01 PR, 30 mg; Administered by deep IM injection (gluteus) on days 1 and 42

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Compare the mean serum concentrations of insulin-like growth factor-1 (IGF-1) and growth hormone (GH) in patients treated with C2L-OCT-01 PR, 30 mg or Sandostatin LAR 30 mg	Days 1, 28, 42, 56 and 84

Secondary Outcome Measures

Outcome Measure	Time Frame
Compare plasma concentrations, efficacy and safety profile of C2L-OCT-01 PR	84 days

Collaborators and Investigators

• Sponsor: Ambrilia Biopharma, Inc.
• Investigators: Study Director: Raphael Naudin, M.D., Ambrilia Biopharma, Inc.

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (Actual): February 1, 2008
• Study Completion (Actual): February 1, 2008

Study Registration Dates

• First Submitted: February 4, 2008
• First Submitted That Met QC Criteria: February 4, 2008
• First Posted (Estimate): February 15, 2008

Study Record Updates

• Last Update Posted (Estimate): October 8, 2008
• Last Update Submitted That Met QC Criteria: October 7, 2008
• Last Verified: October 1, 2008

More Information

Terms related to this study

• Keywords: Acromegaly
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Musculoskeletal Diseases; Hypothalamic Diseases; Bone Diseases; Bone Diseases, Endocrine; Hyperpituitarism; Pituitary Diseases; Acromegaly; Antineoplastic Agents; Gastrointestinal Agents; Antineoplastic Agents, Hormonal; Octreotide
• Other Study ID Numbers: C2L-OCT-01 PR-301