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Safety and Biological Activity 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


Phase 3
18 Years
N/A
Not Enrolling
Both
Acromegaly

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Trial Information

Safety and Biological Activity 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

Inclusion Criteria


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

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.

Safety Issue:

Yes

Principal Investigator

Raphael Naudin, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Ambrilia Biopharma, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

C2L-OCT-01 PR-303

NCT ID:

NCT00642421

Start Date:

February 2008

Completion Date:

August 2009

Related Keywords:

  • Acromegaly
  • Acromegaly
  • Acromegaly

Name

Location

Stanford University Medical CenterStanford, California  94305-5408
VA Puget Sound Health Care SystemSeattle, Washington  98101
The Cleveland ClinicCleveland, Ohio  44195
UCLA Medical Center Division of NeurosurgeryLos Angeles, California  90095
Kaleida Health/Diabetes Center of WNYBuffalo, New York  14206