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

This study has been terminated.
(Preliminary data from this study does not support expected inhibition of GH and IGF-1)
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT00994214
First received: October 13, 2009
Last updated: January 7, 2016
Last verified: November 2015
  Purpose
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.

Condition Intervention Phase
Acromegaly
Drug: BIM 23A760
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II, Open, Randomised, Parallel Group, Noncomparative Multicentre Study to Assess the Efficacy and Safety of Repeated Subcutaneous (S.C.) Administration of Different Doses of BIM 23A760 in Acromegalic Patients

Resource links provided by NLM:


Further study details as provided by Ipsen:

Primary Outcome Measures:
  • Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 [ Time Frame: At Month 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 [ Time Frame: At Month 3 ] [ Designated as safety issue: No ]
  • Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 [ Time Frame: At Month 1 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6 [ Time Frame: 0-3 hr on Baseline (Day 1) and Months 1, 3 and 6 ] [ Designated as safety issue: No ]
    Percentage change from Baseline at month X = (Mean GH at month X - Mean GH at baseline) x 100 / Mean GH at baseline

  • Changes in IGF-1 [ Time Frame: Baseline (Day 1) and Month 6 ] [ Designated as safety issue: No ]
  • Percentage Change in Ring Finger Circumference [ Time Frame: Baseline (Day 1) and Month 6 ] [ Designated as safety issue: No ]
    Percentage change from Baseline at month X = (Ring finger circumference at month X - ring finger circumference at baseline) x 100 / ring finger circumference at baseline.

  • Number of Subjects Reported Adverse Events During the Study [ Time Frame: Up to Visit 10 (An average of 6.5 Months) ] [ Designated as safety issue: Yes ]

    For summaries of intensity and causality, individual patients may be reported in more than one category. In the event of multiple episodes of AEs being reported by the same patient during the study, the maximum intensity (severe > moderate > mild) and the most serious causality (related > not related) have been chosen.

    TEAE (Treatment emergent adverse event) are reported by Maximum Dose Received in Each Part of the Study.



Enrollment: 109
Study Start Date: October 2009
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BIM 23A760 1 mg Drug: BIM 23A760
Subcutaneous injections of BIM23A760 once a week. Until progression or unacceptable toxicity develops.
Experimental: BIM 23A760 2 mg Drug: BIM 23A760
Subcutaneous injections of BIM23A760 once a week. Until progression or unacceptable toxicity develops.
Experimental: BIM 23A760 4 mg Drug: BIM 23A760
Subcutaneous injections of BIM23A760 once a week. Until progression or unacceptable toxicity develops.
Experimental: BIM 23A760 6 mg Drug: BIM 23A760
Subcutaneous injections of BIM23A760 once a week. Until progression or unacceptable toxicity develops.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  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: NCT00994214

  Show 23 Study Locations
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Catherine Lesage, MD Ipsen
  More Information

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT00994214     History of Changes
Other Study ID Numbers: 2-55-52060-003 
Study First Received: October 13, 2009
Results First Received: October 14, 2015
Last Updated: January 7, 2016
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Czech Republic: State Institute for Drug Control
Lithuania: State Medicine Control Agency - Ministry of Health
Latvia: State Agency of Medicines
Germany: Federal Institute for Drugs and Medical Devices
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation
Romania: National Medicines Agency
Ukraine: State Pharmacological Center - Ministry of Health
Italy: The Italian Medicines Agency
Mexico: Ethics Committee
Brazil: Ethics Committee
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Canada: Health Products and Food Branch (HPFB)

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
Dopamine
Somatostatin
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 24, 2016