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

Stopped early · Phase 3

Conditions studied: Acromegaly

In brief

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.

Key facts

Study ID

NCT00642421

Run by

Ambrilia Biopharma, Inc.

People needed

40

Starts

2008-02-01

Expected to finish

2009-08-01

Last updated by the study team

2010-02-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• To be eligible for entry in this study, patient must NOT:
• If female, be pregnant or lactating.
• Have been treated with a GH receptor antagonist (pegvisomant) within the last 12 weeks.
• Have used a dopamine agonist within the last 30 days.
• Have undergone pituitary surgery within the last 12 weeks.
• Have undergone radiotherapy within the last two years.
• Have any contraindication (hypersensitivity to octreotide formulation) or non-responders to Sandostatin-LAR® treatment.
• Be currently treated with Sandostatin-LAR® and have symptoms of acromegaly that would justify, in the Investigator's opinion, a dose modification.
• Be receiving Sandostatin-LAR® administration every < 21 or > 35 days.
• Have a liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis, or has persistent ALT, AST > 2 X ULN, serum creatinine > 2 X ULN, serum bilirubin > 2 X ULN.
• Have any other conditions that could result in altered GH or IGF-1 levels (such as anorexia nervosa, Laron's syndrome, treatment with levodopa or narcotics analgesics, heroin abuse.)
• Have type I diabetes (insulin-dependent) or uncontrolled type II diabetes (non-insulin-dependent) as indicated by the presence of ketoacidosis or HbA1C greater than or equal to 10%.
• Have clinically significant signs and symptoms potentially related to a tumor compression of the optical chiasm, based on judgment of the investigator.
• Have symptomatic cholelithiasis.
• Have received an investigational drug or participated in a clinical trial within the last 30 days.
• Have 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.

Where it is running

• 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
• The Cleveland Clinic — Cleveland, Ohio, United States
• VA Puget Sound Health Care System — Tacoma, Washington, 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
• Institute of Endocrinology, University Clinical Center — Belgrade, Serbia
• V.P. Komisarenko Institute of Endocrinology and Metabolism, AMS Ukraine — Kiev, Ukraine

Full record on ClinicalTrials.gov

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