Study to Assess the Efficacy and Safety of Repeated Administration of BIM 23A760 in Patients With Acromegaly

NCT00994214 | Terminated Phase 2 Results

• 2 other identifiers: 2-55-52060-0032009-010787-42
• Study Type: interventional
• Target: 109
• Locations: 13 countries
• Sites: 23

Brief Summary

The purpose of this study is to assess the efficacy of repeated subcutaneous (under the skin) injections at different doses of BIM 23A760 on growth hormone and insulin-like growth factor-1 levels in patients with acromegaly after 6 months of treatment.

Conditions

Acromegaly

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1

  At Month 6

Secondary Outcomes (6)

• Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1

  At Month 3

• Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1

  At Month 1

• Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6

  0-3 hr on Baseline (Day 1) and Months 1, 3 and 6

• Changes in IGF-1

  Baseline (Day 1) and Month 6

• Percentage Change in Ring Finger Circumference

  Baseline (Day 1) and Month 6

Study Arms (4)

BIM 23A760 1 mg

EXPERIMENTAL

Drug: BIM 23A760

BIM 23A760 2 mg

EXPERIMENTAL

Drug: BIM 23A760

BIM 23A760 4 mg

EXPERIMENTAL

Drug: BIM 23A760

BIM 23A760 6 mg

EXPERIMENTAL

Drug: BIM 23A760

Interventions

BIM 23A760 DRUG

Subcutaneous injections of BIM23A760 once a week. Until progression or unacceptable toxicity develops.

BIM 23A760 1 mg; BIM 23A760 2 mg; BIM 23A760 4 mg; BIM 23A760 6 mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• IGF-1 ≥1.3 x upper limit normal (ULN)
• Nadir serum GH concentration ≥0.4 ng/mL in an oral glucose tolerance test (OGTT)
• Patient must have documentation supporting the diagnosis of acromegaly, including elevated GH and/or insulin-like growth factor-1 (IGF-1) levels.

You may not qualify if:

• The patient has received long acting somatostatin analogues within 6 months of study entry
• The patient has undergone radiotherapy at any time prior to study entry
• The time between pituitary surgery (if any) and study entry is less than 6 weeks
• The patient suffers from macroadenoma with visual field defects due to chiasmatic compression

Sponsors & Collaborators

• Ipsen: lead

Study Sites (23)

Pituitary Center

Los Angeles, California, 90048, United States

Location

Massachusetts General Hospital / Neuroendocrine Unit

Boston, Massachusetts, 02114, United States

Location

Oregon University, Dept. of Endocrinology and Neurosurgery

Portland, Oregon, 97239, United States

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Centre Hospitalier Universitaire de Liège

Liège, B-4000, Belgium

Location

Hospital Universitário Clementino Fraga Filho

Rio de Janeiro, 21941-913, Brazil

Location

Hospital das Clínicas de São Paulo

São Paulo, 05403-0000, Brazil

Location

University Hospital Olomouc, Clinic of Internal Medicine

Olomouc, 775 20, Czechia

Location

General University Hospital, Clinic of Internal Medicine,

Prague, 128 08, Czechia

Location

Hôpital Bicêtre

Le Kremlin-Bicêtre, 94275 Cedex, France

Location

Hôpital de la Timone

Marseille, 13385 Cedex 05, France

Location

P. Stradins Clinical University Hospital

Riga, LV 1002, Latvia

Location

Kaunas Medical University Hospital

Kaunas, LT-50009, Lithuania

Location

Vilnius University Hospital "Santariskiu Klinikos"

Vilnius, LT-08661, Lithuania

Location

UIM Endocrinología Experimental, Hospital de Especialidades

Mexico City, DF, Mexico

Location

Insituto Nacional de Neurologia y Neurocirugia

México, 14269 México, Mexico

Location

Department of Endocrinology, Erasmus MC

Rotterdam, 3000 CA, Netherlands

Location

Voivodeship Specialistic Hospital No 3

Rybnik, 44-200, Poland

Location

"C.I. Parhon" National Institute of Endocrinology

Bucharest, 011863, Romania

Location

Karolinska University Hospital

Stockholm, 171 76, Sweden

Location

Academy of Medical Science of Ukraine, Department of Clinical Endocrinology

Kharkiv, 61002, Ukraine

Location

Administration of Medical Services and Rehabilitation of "ARTEM"

Kyiv, 04050, Ukraine

Location

National Medical University n.a. M.I.Pirogov

Vinnitsa, 21010, Ukraine

Location

MeSH Terms

Conditions

Acromegaly

Interventions

TBR-760

Condition Hierarchy (Ancestors)

Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Limitations and Caveats

The study was terminated prematurely due to lack of efficacy.

Results Point of Contact

• Title: Medical Director, Endocrinology
• Organization: Ipsen

clinical.trials@ipsen.com

clinical.trials@ipsen.com

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2009
• First Posted: October 14, 2009
• Study Start: October 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: November 22, 2019
• Results First Posted: February 10, 2016

Record last verified: 2019-11

Locations

FR (2); PL (1); CZ (2); SE (1); LI (2); BE (2); BR (2); LA (1); ME (2); UA (3); US (3); RO (1); NL (1)