Safety and Biological Activity of C2L-OCT-01 PR in Acromegalic Patients
Safety and Biological Activity of C2L-OCT-01 PR in Acromegalic Patients
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.
To be eligible for entry in this study, patient must:

 -  Be greater than or equal to 18 years of age.

 -  Have a confirmed diagnosis of acromegaly based on the following criteria:

 1. Typical clinical features and

 2. Mean GH concentration > 1.0 ng/mL following an oral glucose tolerance test (OGTT)
 and

 3. Elevated serum IGF-1 levels above gender- and age- matched values.

 -  Fall into one of the following categories:

 1. Has been treated for at least the last 12 weeks with Sandostatin LAR® 10 mg or 20
 mg, every 28 days with well-controlled symptoms of acromegaly and GH
 concentration < 2.5 ng/mL at screening or

 2. Be naïve to prolonged release octreotide with a demonstrated tolerance response
 to a 7-day administration of Sandostatin® immediate release (50 µg s.c. t.i.d.)
 or

 3. If previously treated with prolonged release octreotide, has stopped such
 treatment for at least 12 weeks prior to screening.

 -  If female and of childbearing potential, must have a negative pregnancy test at
 screening and be using adequate means of birth control (i.e., oral or trans-dermal
 contraceptive drugs, intra-uterine device, diaphragm) during the study.

 -  Have 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.

 Exclusion Criteria

 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.