Study to Determine the Maximum Tolerated Dose, Safety and Tolerability of a Single Dose of Lanreotide Prolonged Release Formulation (PRF) in Subjects With Acromegaly

Learn more about:
Related Clinical Trial
Rhinological Outcomes in Endonasal Pituitary Surgery Co-treatment With Pegvisomant and a Somatostatin Analogue (SA) in SA-responsive Acromegalic Patients Study to Allow Access to Pasireotide for Patients Benefiting From Pasireotide Treatment in Novartis-sponsored Studies A Four-Part Study to Assess the Safety, Tolerability, PK and PD of ONO-5788 in Healthy Adult Volunteers The Effect of Subcutaneous Infusions of 3 Doses of DG3173 on Growth Hormone Levels in Untreated Acromegalics One Year Follow-up of Study 2-79-52030-207 (PRIMARYS) in Acromegalic Patients With Macroadenoma Study in Polish Acromegalic Patients Treated With Somatuline Autogel Long Term Use of Somavert (Pegvisomant) For A Regulatory Post Marketing Commitment Plan Predictive Factors of Response to Somatostatin Analogues in Acromegalic Patients With Persistent Disease Following Surgery The Observational Study of Growth Hormone-secreting Pituitary Tumors Change in Quality of Life After Addition of Weekly 40 mg Pegvisomant/Placebo in Controlled Acromegalic Patients Study to Evaluate the Efficacy and Safety of Sandostatin LAR at High Dose or in Combination Either With GH-receptor Antagonist or Dopamine-agonist in Acromegalic Patients Efficacy and Safety of Lanreotide Autogel (60, 90 or 120 mg) in Acromegalic Patients Substrate Metabolism and Insulin Sensitivity in Acromegalic Patients Before and After Treatment Single-dose Study to Evaluate the Absolute Bioavailability and Mass Balance of ONO-5788 Study Comparing SOM230 Subcutaneously and Sandostatin Subcutaneously in Acromegalic Patients Therapeutic Strategies in Acromegalic Subjects Treated With Lanreotide 120mg Preoperative Lanreotide Treatment in Acromegalic Patients With Macroadenomas Study to Assess the Efficacy of an Extended Injection Interval Schedule of Lanreotide Autogel in Acromegalic Subjects Phase II Study With ITF2984 in Acromegalic Patients Non Interventional Study For Patients Treated With Somavert® Single Dose Pharmacology Study of DG3173 and Octreotide in Acromegalic Patients. Estrogen Treatment in Acromegalic Women Pharmacodynamics Of Product Octreotide Acetate Lar 30 Mg, Imported And Distributed By The Laboratory Chemical Pharmaceutical Bergamo Ltda., Compared To Product Sandostatin LAR ® (Octreotide Acetate LAR) 30 MG Manufactured By Novartis Biosciences S / A. ACRODAT Prospective Evaluation Study Pegvisomant And Sandostatin LAR Combination Study Lanreotide as Primary Treatment for Acromegalic Patients With Pituitary Gland Macroadenoma Open Label Extension Study Evaluating Safety and Biological Activity of C2L-OCT-01 PR in Acromegalic Patients Efficacy and Safety of C2L-OCT-01 PR in Acromegalic Patients Efficacy of Octreotide Acetate and Cabergoline in Patients With Acromegaly Canadian Pegvisomant Compassionate Study In Acromegalic Patients Efficacy and Safety Study of Varying Doses of Lanreotide Autogel in Patients With Acromegaly Hormonal Outcomes in Acromegalic Patients With Treated Surgery With or Without Long Acting Somatostatin Analogues Tissue Biomarker for Pegvisomant Action Sandostatin LAR Depot vs. Surgery for Treating Acromegaly Safety and Efficacy of Octreotide Long Acting Release (LAR) in Treatment Naïve Acromegalic Patients Lanreotide Autogel 120 mg at Extended Dosing Intervals (>4 Weeks) in Acromegalic Subjects Comparable Effects of Lanreotide Autogel and Octreotide LAR on GH, IGF-I Levels and Patient Satisfaction Predictive Factors Study Sleep Apnea Syndrome on Acromegaly: Impact of the Treatment on the Carbohydrates Metabolism. Growth Hormone Feedback to Insulin-like Growth Factor-I (IGF-1) and Oral Glucose Tolerance Test (OGTT) Somatostatin Analog Treatment of Acromegaly Before Pituitary Surgery : Comparison With Neurosurgery Alone Effect of 120mg Somatuline Autogel at Different Dose Intervals (28, 42 or 56 Days) in Patients With Acromegaly Acromegaly – Before and After Treatment Study to Assess the Efficacy and Safety of Repeated Administration of BIM 23A760 in Patients With Acromegaly Measurement of Outcome of Surgical Treatment in Patients With Acromegaly Non Interventional Post Marketing Programme in Acromegaly Short and Long Term Efficacy of Combined Cabergoline and Octreotide Treatment in Acromegalic Patients Cardiovascular Outcome After Surgery or Somatostatin Analogues Efficacy/Safety of Octreotide Acetate in Patients With Uncontrolled Acromegaly Study Assessing the Efficacy and Safety of Octreotide Acetate in Patients With Acromegaly, With Micro or Macroadenomas Long Term Study With B2036-PEG Octreotide Efficacy and Safety in First-line Acromegalic Patients Long-term Safety and Efficacy Study of Octreotide Implant in Patients With Acromegaly An Extension Study to Assess the Long-term Safety and Efficacy of Pasireotide in Patients With Acromegaly Study of the Effect of Growth Hormone-Releasing Hormone Antagonist on Growth Hormone Release in Acromegaly Clomiphene Citrate for Treatment of Acromegaly Cardiac (CMRI) Assessment of Acromegaly Acromegaly Combination Treatment Study Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly Assessment of Changes in Metabolic Activity in Liver & Skeletal Muscle in Patients Suffering From Acromegaly Changes of Left Ventricular Mass and Cardiac Function in Patients With Active Acromegaly During Treatment With the Growth Hormone Receptor Antagonist Pegvisomant Assessment of BIM23B065, Given as Repeated Subcutaneous Injection in Subjects With Acromegaly A Study to Evaluate the Risk of Developing a Heart Condition Called Valvular Regurgitation in Patients With Acromegaly Treated With Either Lanreotide or Octreotide Pasireotide LAR and Pegvisomant Study in Acromegaly Effects of Sandostatin LAR® in Acromegaly Open Label Study of Octreotide Implant in Patients With Acromegaly Efficacy and Safety Study of Octreotide Implant in Patients With Acromegaly Somatuline Autogel: Acromegaly Self/Partner Injection Study A Study To Compare The Efficacy And Safety Of Pegvisomant To That Of Sandostatin Lar Depot In Patients With Acromegaly Efficacy and Tolerability of Lanreotide (Autogel 120 mg) in Patients With Acromegaly Study to Predict Lanreotide-induced Disease Activity Normalization in Acromegaly Impact of Somatostatin Analogs vs. Surgery on Glucose Metabolism in Acromegaly Prospective Study on Changes in Acromegaly Study to Determine the Maximum Tolerated Dose, Safety and Tolerability of a Single Dose of Lanreotide Prolonged Release Formulation (PRF) in Subjects With Acromegaly Dose Escalation of Octreotide-LAR as First-Line Therapy in Resistant Acromegaly Assessment of the Ability of Subjects With Acromegaly or Their Partners to Administer Somatuline Autogel Efficacy and Safety of Lanreotide Autogel® 60, 90 or 120 mg With Lanreotide 40 mg Prolonged Release (PR) in Acromegaly An Open-label, Multi-center, Expanded Treatment Protocol of Pasireotide LAR in Patients With Acromegaly Assessment of Airway in Patients With Acromegaly for Predicting Successful Tracheal Intubation Quality of Life (QoL) in Subjects With Acromegaly Under Lanreotide Autogel® Treatment. A Study to Evaluate the Long-Term Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Advance) An Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Edge) Study to Evaluate Patients With Acromegaly Treated With Lanreotide Autogel (Somatuline ATG) IGF-I and Free Fatty Acids Isn Glucose Metabolism in Acromegaly Safety and Efficacy of Pasireotide Long Acting Release (LAR) vs. Octreotide LAR in Patients With Active Acromegaly Study of Management of Pasireotide-induced Hyperglycemia in Adult Patients With Cushing’s Disease or Acromegaly Growth Hormone, IGF-1 and Medical Treatment in Acromegaly: Are There Effects on Gut Hormone Physiology and Postprandial Substrate Metabolism? Efficacy and Safety of Pasireotide Long Acting Release (LAR) Versus Octreotide LAR or Lanreotide Autogel (ATG) in Patients With Inadequately Controlled Acromegaly Rehabilitation Program in Patients With Acromegaly Acute Application of Pegvisomant and Octreotide in Acromegaly Lanreotide Autogel-120 mg as First-Line Treatment of Acromegaly Prediction of Tumor Shrinkage in Acromegaly Somatostatin Analogue Treatment of Acromegaly: Molecular Aspects Safety and Efficacy of Long-acting Repeatable Octreotide Acetate for Injectable Suspension vs. Surgery in Treatment-naïve Patients With Acromegaly SAGIT for Classification of Patients With Acromegaly in Clinical Practice Lanreotide Autogel in Patients With Acromegaly Previously Treated With Octreotide LAR Olfactory Function and Olfactory Bulb Volume in Acromegaly Patients Late Effects of Radiosurgery on Acromegaly Study Ultrasound Guided Octreotide LAR Injection in Acromegaly Comparison of Oral Octreotide Capsules to Injectable Somatostatin Analogs in Acromegaly A Trial to Assess the Long-term Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly Safety, Tolerability, and Efficacy of IONIS-GHR-LRx in Patients With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly Strict IGF-1 Control in Acromegaly Extension Study of IONIS-GHR-LRx Administered to Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands Treatment of Acromegaly With Somatostatin Analogs: GH vs. IGF-I as Primary Biochemical Target Fractionated Stereotactic Radiotherapy in Patients With Acromegaly Validation Study of the SAGIT® Instrument in Acromegaly Developing a Simple Recognition System of Acromegaly Glucose Tolerance in Acromegaly: The Influence of GH-excess on Glucose Metabolism and Insulin Resistance Surgical Versus Medical Treatment of Acromegaly A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Evolve) Acromegaly & Sleep Apnoea Somatuline Predictive Factors in Acromegaly and NET Acromegaly Treatment Quality of Life Study Lanreotide Levels in Acromegaly Description of Sign-and-symptom Associations at Acromegaly Diagnosis. Treatment Patterns and Treatment Outcomes for Acromegaly Ectopic Lipid Deposition and Insulin Resistance in After Treatment of Acromegaly Physiopathology of Sodium Retention in Acromegaly Somatuline® Depot (Lanreotide) for Acromegaly Post-Marketing Observational Study Peri- and Post-operative Dynamics of the Growth Hormone Axis in Subjects With Acromegaly During the First Year After Surgical Resection The Longitudinal Approach to Acromegaly: A Pattern of Treatment and Comparative Effectiveness Research Preoperative Octreotide Treatment of Acromegaly The Treatment and Natural History of Acromegaly Bone MicroArchitecture in Acromegaly Reproducibility and Utility of OGTT in Acromegaly A Prospective Study of Outcome After Therapy for Acromegaly Epidemiology of Acromegaly in Denmark 1991-2010 Programme of Acromegaly Screening in Patients With Associated Somatic Disorders Acromegaly: Patient And Physician Perspectives

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