Brief Title
Study to Determine the Maximum Tolerated Dose, Safety and Tolerability of a Single Dose of Lanreotide Prolonged Release Formulation (PRF) in Subjects With Acromegaly
Official Title
Phase IIa, Open Label, Dose Ascending Study to Determine the Maximum Tolerated Dose, Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Lanreotide PRF in Subjects With Acromegaly Previously Treated and Controlled With Either Octreotide LAR or Lanreotide Autogel
Brief Summary
The objectives of the protocol is to determine the maximum tolerated dose and to investigate
the pharmacokinetics of a single dose of lanreotide PRF in subjects with acromegaly.
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Determination of the Maximum Tolerated Dose (MTD) by Number of Subjects With DLTs.
Secondary Outcome
Overall Summary of Number of Subjects With AEs.
Condition
Acromegaly
Intervention
Lanreotide PRF
Study Arms / Comparison Groups
lanreotide PRF
Description: One single dose of lanreotide PRF (via subcutaneous injection) either 180mg or 270mg or 360mg.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
28
Start Date
March 2015
Completion Date
November 28, 2017
Primary Completion Date
November 28, 2017
Eligibility Criteria
Inclusion Criteria:
- Documented diagnosis of acromegaly.
- Provided written informed consent prior to any study related procedures.
- Between 18 and 75 years of age inclusive.
- Female of non-childbearing potential or male. Non-childbearing potential is defined as
being postmenopausal for at least 1 year, or women with documented infertility
(natural or acquired).
- Male subjects must agree that, if their partner is at risk of becoming pregnant, they
will use a medically accepted, effective method of contraception (i.e. condom) for the
duration of the study (maximum of 7.5 months).
- Treatment with a stable dose of either octreotide LAR or lanreotide Autogel for at
least 3 months immediately prior to study entry, with confirmation of disease control
during this treatment period (documentation of age adjusted IGF 1 <1.3 x upper limit
of normal (ULN), based on local laboratory results, during screening period).
- If the subject is receiving treatment for hypertension, the dose has been stable for
at least 1 month prior to study entry.
- Subjects must be willing and able to comply with study restrictions and to remain at
the clinic for the required duration during the study period and willing to return to
the clinic for the follow up evaluation as specified in the protocol.
Exclusion Criteria:
- Has undergone radiotherapy within 2 years prior to study entry.
- Has been treated with a dopamine agonist and/or GH receptor antagonist or has
undergone pituitary surgery within 3 months prior to study entry.
- Is anticipated to require pituitary surgery or radiotherapy during the study.
- Has clinically significant hepatic abnormalities and/or alanine aminotransferase (ALT)
and/or aspartate aminotransferase (AST) ≥3 x ULN and/or alkaline phosphatase (AP) ≥2.5
x ULN and/or total bilirubin ≥1.5 x ULN and/or gamma-glutamyl transpeptidase (GGT)
≥2.5 x ULN during the Screening period (central laboratory results) or a history of
these findings when on somatostatin analogue (SSTa) treatment.
- Has clinically significant pancreatic abnormalities and/or amylase and/or lipase ≥1.5
x ULN during the Screening period (central laboratory results).
- Has any significant renal abnormalities and/or creatinine ≥1.5 x ULN during the
screening period (central laboratory results).
- Has uncontrolled diabetes (glycosylated haemoglobin (HbA1c) ≥9%, centrally assessed
during the Screening period), or has diabetes treated with insulin for less than 6
months prior to study entry.
- Has any known uncontrolled cardiovascular disease or had any of the following within 6
months of Screening: ventricular or atrial dysrhythmia
≥grade 2, bradycardia ≥grade 2, electrocardiogram (ECG) QT interval corrected (QTc)
prolonged ≥grade 2, myocardial infarction, severe/unstable angina, symptomatic
congestive heart failure, cerebrovascular accident or transient ischemic attack,
pulmonary embolism, hypertension not adequately controlled by current medications.
- Use of any hormone replacement therapy (HRT) with oestrogens.
- Has symptomatic gallstones/ sludge at the Screening Visit echography (local
assessment) OR is asymptomatic but has echography showing clear evidence of impending
inflammation such as localised mucosal thickening suggesting the subject is at high
risk of developing acute disease. Subjects with asymptomatic gallstones/ sludge and
otherwise normal echography may be entered at the discretion of the investigator.
- Has abnormal findings during the Screening period, any other medical condition(s) or
laboratory findings that, in the opinion of the investigator, might jeopardise the
subject's safety.
- Has been treated with any other investigational medicinal product (IMP) prior to the
first study visit without undergoing a washout period of seven times the elimination
half-life of the investigational compound.
- Has a known hypersensitivity to any of the test materials or related compounds.
- Is likely to require treatment during the study with drugs that are not permitted by
the study protocol.
- Has a history of, or known current, problems with alcohol or drug abuse.
- Has any mental condition rendering him/her unable to understand the nature, scope and
possible consequences of the study, and/or evidence of an uncooperative attitude.
Gender
All
Ages
18 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
Ipsen Medical Director, ,
Location Countries
Belgium
Location Countries
Belgium
Administrative Informations
NCT ID
NCT02396953
Organization ID
8-55-52030-309
Secondary IDs
2014-002389-62
Responsible Party
Sponsor
Study Sponsor
Ipsen
Study Sponsor
Ipsen Medical Director, Study Director, Ipsen
Verification Date
April 2019