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

Acromegaly Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00642421
• Other study ID #: C2L-OCT-01 PR-303
• Status: Terminated
• Phase: Phase 3
• First received: March 21, 2008
• Last updated: February 7, 2010
• Start date: February 2008
• Est. completion date: August 2009

Study information

• Verified date: February 2010
• Source: Ambrilia Biopharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationHungary: National Institute of Pharmacy
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Acromegaly

Intervention

Drug:
• C2L-OCT-01 PR, 10 or 20 mg
The first three injections of study medication will be given at V1 (Day 1), V2 (35 days) and V3 (70 days). Dose titration and/or injection interval adjustment will be allowed during the Treatment Period should any patients have a mean GH concentration below 1.0 ng/mL or above 2.5 ng/mL. Dose titration (10, 20 or 30 mg) and/or injection interval adjustment (4, 5 or 6 weeks) will be allowed at V3, V6 and V9 based on clinical symptoms and the mean GH concentration determined at V2, V5 and V8.
• C2L-OCT-01 PR, 20 mg
The first three injections of study medication will be given at V1 (Day 1), V2 (Day 35) and V3 (Day 70). Dose titration and/or injection interval adjustment will be allowed during the Treatment Period should any patients have a mean GH concentration below 1.0 ng/mL or above 2.5 ng/mL. Dose titration (10, 20 or 30 mg) and/or injection interval adjustment (4, 5 or 6 weeks) will be allowed at V3, V6 and V9 based on clinical symptoms and the mean GH concentration determined at V2, V5 and V8.

Locations

Country	Name	City	State
Belarus	Republican Centre for Medical Rehabilitation and Water-therapy	Minsk
Hungary	Semmelweis Egyetem Altalanos Orvostudomanyi	Budapest
Romania	Institute of Endocrinology "C.I. Parhon" Bucharest	Bucharest
Serbia	Institute of Endocrinology, University Clinical Center	Belgrade
Ukraine	V.P. Komisarenko Institute of Endocrinology and Metabolism, AMS Ukraine	Kiev
United States	Kaleida Health/Diabetes Center of WNY	Buffalo	New York
United States	The Cleveland Clinic	Cleveland	Ohio
United States	UCLA Medical Center Division of Neurosurgery	Los Angeles	California
United States	Stanford University Medical Center	Stanford	California
United States	VA Puget Sound Health Care System	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Ambrilia Biopharma, Inc.

Countries where clinical trial is conducted

United States,  Belarus,  Hungary,  Romania,  Serbia,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		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.	Yes
Secondary	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.		Screening, Visits 1 through 11, and End of Study Visit.	No
Secondary	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.		Screening, Visits 1 through 11, and End of Study Visit.	No
Secondary	To assess the biologic and clinical activity of C2L-OCT-01 PR by examining the acromegaly severity index and patient's health status scores.		Screening, Visit 1 through 11, and End of Study Visit.	No
Secondary	To assess biological and clinical activity of C2L-OCT-01 PR by examining the pituitary tumor size.		Screening, Visit 6 and End of Study Visit.	No