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

October 13, 2009
January 7, 2016
October 2009
February 2011   (final data collection date for primary outcome measure)
Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 [ Time Frame: At Month 6 ] [ Designated as safety issue: No ]
Proportion of patients with mean growth hormone (GH)≤2.5 ng/mL and normalised insulin-like growth factor-1 (IGF-1) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00994214 on ClinicalTrials.gov Archive Site
  • 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.

  • Proportion of patients with mean GH≤2.5 ng/mL and normalised IGF-1 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Ring finger measurement [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Clinical laboratory tests [ Time Frame: Every visit ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: At every visit ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Study to Assess the Efficacy and Safety of Repeated Administration of BIM 23A760 in Patients With Acromegaly
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acromegaly
Drug: BIM 23A760
Subcutaneous injections of BIM23A760 once a week. Until progression or unacceptable toxicity develops.
  • Experimental: BIM 23A760 1 mg
    Intervention: Drug: BIM 23A760
  • Experimental: BIM 23A760 2 mg
    Intervention: Drug: BIM 23A760
  • Experimental: BIM 23A760 4 mg
    Intervention: Drug: BIM 23A760
  • Experimental: BIM 23A760 6 mg
    Intervention: Drug: BIM 23A760
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
109
February 2011
February 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Brazil,   Czech Republic,   France,   Latvia,   Lithuania,   Mexico,   Netherlands,   Poland,   Romania,   Sweden,   Ukraine
Canada,   Germany,   Italy,   Russian Federation,   United Kingdom
 
NCT00994214
2-55-52060-003
No
Not Provided
Not Provided
Ipsen
Ipsen
Not Provided
Study Director: Catherine Lesage, MD Ipsen
Ipsen
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP