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

This study has been terminated.
(Commercial reasons)
Sponsor:
Information provided by:
Ambrilia Biopharma, Inc.
ClinicalTrials.gov Identifier:
NCT00642421
First received: March 21, 2008
Last updated: February 7, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Acromegaly
Drug: C2L-OCT-01 PR, 10 or 20 mg
Drug: C2L-OCT-01 PR, 20 mg
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Ambrilia Biopharma, Inc.:

Primary Outcome Measures:
  • 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. [ 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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. [ Time Frame: Screening, Visits 1 through 11, and End of Study Visit. ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: Screening, Visits 1 through 11, and End of Study Visit. ] [ Designated as safety issue: No ]
  • To assess the biologic and clinical activity of C2L-OCT-01 PR by examining the acromegaly severity index and patient's health status scores. [ Time Frame: Screening, Visit 1 through 11, and End of Study Visit. ] [ Designated as safety issue: No ]
  • To assess biological and clinical activity of C2L-OCT-01 PR by examining the pituitary tumor size. [ Time Frame: Screening, Visit 6 and End of Study Visit. ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: February 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Population A
Based on the dose of their previous Sandostatin-LAR treatment, Population A will receive 10 or 20 mg of C2L-OCT-01 PR at 5-week intervals.
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.
Other Name: octreotide acetate
Experimental: Population B
Population B, naive patients and patients who have stopped their treatment with prolonged release octreotide for at least 12 weeks, will receive 20 mg C2L-OCT-01 PR at 5-week intervals.
Drug: 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.
Other Name: octreotide acetate

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00642421

Locations
United States, California
UCLA Medical Center Division of Neurosurgery
Los Angeles, California, United States, 90095
Stanford University Medical Center
Stanford, California, United States, 94305-5826
United States, New York
Kaleida Health/Diabetes Center of WNY
Buffalo, New York, United States, 14206
United States, Ohio
The Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Washington
VA Puget Sound Health Care System
Tacoma, Washington, United States, 98489
Belarus
Republican Centre for Medical Rehabilitation and Water-therapy
Minsk, Belarus
Hungary
Semmelweis Egyetem Altalanos Orvostudomanyi
Budapest, Hungary
Romania
Institute of Endocrinology "C.I. Parhon" Bucharest
Bucharest, Romania
Serbia
Institute of Endocrinology, University Clinical Center
Belgrade, Serbia
Ukraine
V.P. Komisarenko Institute of Endocrinology and Metabolism, AMS Ukraine
Kiev, Ukraine
Sponsors and Collaborators
Ambrilia Biopharma, Inc.
Investigators
Study Director: Raphael Naudin, M.D. Ambrilia Biopharma, Inc.
  More Information

No publications provided

Responsible Party: Bonabes de Rouge, M.D./Senior Executive Vice-President & Chief Scientist Officer, Ambrilia Biopharma, Inc.
ClinicalTrials.gov Identifier: NCT00642421     History of Changes
Other Study ID Numbers: C2L-OCT-01 PR-303
Study First Received: March 21, 2008
Last Updated: February 7, 2010
Health Authority: United States: Food and Drug Administration
Hungary: National Institute of Pharmacy

Keywords provided by Ambrilia Biopharma, Inc.:
Acromegaly

Additional relevant MeSH terms:
Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Octreotide
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 16, 2014