Clinical trial NCT00642421: Safety and Biological Activity of C2L-OCT-01 PR in Acromegalic Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Acromegaly
Keywords: Acromegaly
Lead sponsor: Ambrilia Biopharma, Inc.
Sponsor class: INDUSTRY
First posted: 2008-03-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
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.
timeFrame: 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.
Secondary outcomes:
measure: To assess biological and clinical activity of C2L-OCT-01 PR by examining the percentage of patients with mean growth hormone (GH) <2.5 ng/ml.
timeFrame: Screening, Visits 1 through 11, and End of Study Visit.
measure: To assess the biologic and clinical activity of C2L-OCT-01 PR by examining the mean changes from baseline in GH and IGF-1 concentrations.
timeFrame: Screening, Visits 1 through 11, and End of Study Visit.
measure: To assess the biologic and clinical activity of C2L-OCT-01 PR by examining the acromegaly severity index and patient's health status scores.
timeFrame: Screening, Visit 1 through 11, and End of Study Visit.
measure: To assess biological and clinical activity of C2L-OCT-01 PR by examining the pituitary tumor size.
timeFrame: Screening, Visit 6 and End of Study Visit.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Medical Center Division of Neurosurgery
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Buffalo
country: United States
facility: Kaleida Health/Diabetes Center of WNY
state: New York
city: Cleveland
country: United States
facility: The Cleveland Clinic
state: Ohio
city: Tacoma
country: United States
facility: VA Puget Sound Health Care System
state: Washington
city: Minsk
country: Belarus
facility: Republican Centre for Medical Rehabilitation and Water-therapy
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Altalanos Orvostudomanyi
city: Bucharest
country: Romania
facility: Institute of Endocrinology "C.I. Parhon" Bucharest
city: Belgrade
country: Serbia
facility: Institute of Endocrinology, University Clinical Center
city: Kiev
country: Ukraine
facility: V.P. Komisarenko Institute of Endocrinology and Metabolism, AMS Ukraine
Study officials:
affiliation: Ambrilia Biopharma, Inc.
name: Raphael Naudin, M.D.
role: STUDY_DIRECTOR
References: