search
Back to results

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

Primary Purpose

Acromegaly

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BIM 23A760
Sponsored by
Ipsen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acromegaly

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pituitary Center
  • Massachusetts General Hospital / Neuroendocrine Unit
  • Oregon University, Dept. of Endocrinology and Neurosurgery
  • UZ Leuven
  • Centre Hospitalier Universitaire de Liège
  • Hospital Universitário Clementino Fraga Filho
  • Hospital das Clínicas de São Paulo
  • University Hospital Olomouc, Clinic of Internal Medicine
  • General University Hospital, Clinic of Internal Medicine,
  • Hôpital Bicêtre
  • Hôpital de la Timone
  • P. Stradins Clinical University Hospital
  • Kaunas Medical University Hospital
  • Vilnius University Hospital "Santariskiu Klinikos"
  • UIM Endocrinología Experimental, Hospital de Especialidades
  • Insituto Nacional de Neurologia y Neurocirugia
  • Department of Endocrinology, Erasmus MC
  • Voivodeship Specialistic Hospital No 3
  • "C.I. Parhon" National Institute of Endocrinology
  • Karolinska University Hospital
  • Academy of Medical Science of Ukraine, Department of Clinical Endocrinology
  • Administration of Medical Services and Rehabilitation of "ARTEM"
  • National Medical University n.a. M.I.Pirogov

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

BIM 23A760 1 mg

BIM 23A760 2 mg

BIM 23A760 4 mg

BIM 23A760 6 mg

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1
Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1
Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6
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
Percentage Change in Ring Finger Circumference
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
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.

Full Information

First Posted
October 13, 2009
Last Updated
November 21, 2019
Sponsor
Ipsen
search

1. Study Identification

Unique Protocol Identification Number
NCT00994214
Brief Title
Study to Assess the Efficacy and Safety of Repeated Administration of BIM 23A760 in Patients With Acromegaly
Acronym
TULIPIA
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Terminated
Why Stopped
Preliminary data from this study does not support expected inhibition of GH and IGF-1
Study Start Date
October 2009 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ipsen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acromegaly

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BIM 23A760 1 mg
Arm Type
Experimental
Arm Title
BIM 23A760 2 mg
Arm Type
Experimental
Arm Title
BIM 23A760 4 mg
Arm Type
Experimental
Arm Title
BIM 23A760 6 mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BIM 23A760
Intervention Description
Subcutaneous injections of BIM23A760 once a week. Until progression or unacceptable toxicity develops.
Primary Outcome Measure Information:
Title
Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1
Time Frame
At Month 6
Secondary Outcome Measure Information:
Title
Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1
Time Frame
At Month 3
Title
Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1
Time Frame
At Month 1
Title
Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6
Description
Percentage change from Baseline at month X = (Mean GH at month X - Mean GH at baseline) x 100 / Mean GH at baseline
Time Frame
0-3 hr on Baseline (Day 1) and Months 1, 3 and 6
Title
Changes in IGF-1
Time Frame
Baseline (Day 1) and Month 6
Title
Percentage Change in Ring Finger Circumference
Description
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.
Time Frame
Baseline (Day 1) and Month 6
Title
Number of Subjects Reported Adverse Events During the Study
Description
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.
Time Frame
Up to Visit 10 (An average of 6.5 Months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Medical Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
Pituitary Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Massachusetts General Hospital / Neuroendocrine Unit
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Oregon University, Dept. of Endocrinology and Neurosurgery
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Centre Hospitalier Universitaire de Liège
City
Liège
ZIP/Postal Code
B-4000
Country
Belgium
Facility Name
Hospital Universitário Clementino Fraga Filho
City
Rio de Janeiro
ZIP/Postal Code
21941-913
Country
Brazil
Facility Name
Hospital das Clínicas de São Paulo
City
Sao Paulo
ZIP/Postal Code
05403-0000
Country
Brazil
Facility Name
University Hospital Olomouc, Clinic of Internal Medicine
City
Olomouc
ZIP/Postal Code
775 20
Country
Czechia
Facility Name
General University Hospital, Clinic of Internal Medicine,
City
Praha
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Hôpital Bicêtre
City
Le Kremlin Bicêtre
ZIP/Postal Code
94275 Cedex
Country
France
Facility Name
Hôpital de la Timone
City
Marseille
ZIP/Postal Code
13385 Cedex 05
Country
France
Facility Name
P. Stradins Clinical University Hospital
City
Riga
ZIP/Postal Code
LV 1002
Country
Latvia
Facility Name
Kaunas Medical University Hospital
City
Kaunas
ZIP/Postal Code
LT-50009
Country
Lithuania
Facility Name
Vilnius University Hospital "Santariskiu Klinikos"
City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
Facility Name
UIM Endocrinología Experimental, Hospital de Especialidades
City
Mexico City
ZIP/Postal Code
DF
Country
Mexico
Facility Name
Insituto Nacional de Neurologia y Neurocirugia
City
México City
ZIP/Postal Code
14269 México
Country
Mexico
Facility Name
Department of Endocrinology, Erasmus MC
City
Rotterdam
ZIP/Postal Code
3000 CA
Country
Netherlands
Facility Name
Voivodeship Specialistic Hospital No 3
City
Rybnik
ZIP/Postal Code
44-200
Country
Poland
Facility Name
"C.I. Parhon" National Institute of Endocrinology
City
Bucharest
ZIP/Postal Code
011863
Country
Romania
Facility Name
Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Academy of Medical Science of Ukraine, Department of Clinical Endocrinology
City
Kharkiv
ZIP/Postal Code
61002
Country
Ukraine
Facility Name
Administration of Medical Services and Rehabilitation of "ARTEM"
City
Kyiv
ZIP/Postal Code
04050
Country
Ukraine
Facility Name
National Medical University n.a. M.I.Pirogov
City
Vinnitsa
ZIP/Postal Code
21010
Country
Ukraine

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs