NCT00642421

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2008

Geographic Reach
6 countries

10 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 25, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

February 9, 2010

Status Verified

February 1, 2010

Enrollment Period

1.5 years

First QC Date

March 21, 2008

Last Update Submit

February 7, 2010

Conditions

Acromegaly

Keywords

Acromegaly

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (4)

  • 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.

  • 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.

  • 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.

  • 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.

Study Arms (2)

Population A

EXPERIMENTAL

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

Population B

EXPERIMENTAL

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

Interventions

C2L-OCT-01 PR, 10 or 20 mgDRUG

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.

Also known as: octreotide acetate
Population A
C2L-OCT-01 PR, 20 mgDRUG

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.

Also known as: octreotide acetate
Population B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

UCLA Medical Center Division of Neurosurgery

Los Angeles, California, 90095, United States

Location

Stanford University Medical Center

Stanford, California, 94305-5826, United States

Location

Kaleida Health/Diabetes Center of WNY

Buffalo, New York, 14206, United States

Location

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

VA Puget Sound Health Care System

Tacoma, Washington, 98489, United States

Location

Republican Centre for Medical Rehabilitation and Water-therapy

Minsk, Belarus

Location

Semmelweis Egyetem Altalanos Orvostudomanyi

Budapest, Hungary

Location

Institute of Endocrinology "C.I. Parhon" Bucharest

Bucharest, Romania

Location

Institute of Endocrinology, University Clinical Center

Belgrade, Serbia

Location

V.P. Komisarenko Institute of Endocrinology and Metabolism, AMS Ukraine

Kiev, Ukraine

Location

MeSH Terms

Conditions

Acromegaly

Interventions

Octreotide

Condition Hierarchy (Ancestors)

Bone Diseases, EndocrineBone DiseasesMusculoskeletal DiseasesHyperpituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Peptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Raphael Naudin, M.D.

    Ambrilia Biopharma, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 21, 2008

First Posted

March 25, 2008

Study Start

February 1, 2008

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

February 9, 2010

Record last verified: 2010-02

Locations

RO(1)SE(1)UA(1)BE(1)HU(1)US(5)