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

Ambrilia Biopharma

Status and phase: Completed; Phase 3

Conditions: Acromegaly

Treatments: Drug: C2L-OCT-01 PR, 30 mg; Drug: Octreotide acetate prolonged release, 30 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00616551

C2L-OCT-01 PR-301

Details and patient eligibility

About

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.

Enrollment: 65 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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65 participants in 2 patient groups

A

Experimental group

Treatment:

Drug: C2L-OCT-01 PR, 30 mg

B

Active Comparator group

Treatment:

Drug: Octreotide acetate prolonged release, 30 mg