Pasireotide LAR and Pegvisomant Study in Acromegaly

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Brief Title

Pasireotide LAR and Pegvisomant Study in Acromegaly

Official Title

Efficacy and Safety of Pasireotide Long Acting Release (LAR) in Combination With Weekly Pegvisomant in Previously Controlled Acromegaly Patients on Combination Treatment of Long-Acting Somatostatin Analogues and Weekly Pegvisomant

Brief Summary

      The objective of this study is to assess the efficacy of Pasireotide Long Acting Release
      (LAR) alone and in combination with weekly Pegvisomant (PEGV) in acromegaIy patients
      previously controlled with combination treatment of long-acting Somatostatin analogs
      (LA-SSAs) and PEGV.
    

Detailed Description

      Pasireotide Long Acting Release (Signifor ®), a novel long-acting multi-receptor ligand
      somatostatin analogue, has been shown to be more effective for the treatment of GH-secreting
      pituitary adenomas than currently used long-acting somatostatin analogues (LA-SSAs). The
      long-term efficacy of acromegaly patients using LA-SSAs in combination with PEGV was over 90%
      in terms of normalization of IGF-I. The combination of PEGV with pasireotide LAR has not been
      studied yet. Combining PEGV with pasireotide LAR could result in a lower dose and less
      injections of pegvisomant. This may ultimately lead to a more cost-effective treatment and
      improved quality of life.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

The proportion of patients with normalized IGF1 levels at 24 weeks in the pasireotide LAR monotherapy group and in the pasireotide LAR combined with pegvisomant group

Secondary Outcome

 The proportion of patients with normalized IGF1 levels after 48 weeks of pasireotide LAR monotherapy

Condition

Acromegaly

Intervention

Pasireotide LAR 60 mg

Study Arms / Comparison Groups

 Pasireotide LAR 60 mg monotherapy week 12
Description:  After enrollment, acromegaly patients on combination treatment will half their regular weekly dose of pegvisomant (PEGV) for 12 weeks (run-in period).
When insuline-like growth factor 1 (IGF‐I) remains within the age adjusted normal limits after 12 weeks, PEGV and the LA-SSA (Octreotide Long Acting Release (LAR) or Lanreotide Autogel) with Pegvisomant (PEGV) are discontinued and patients are switched to pasireotide LAR 60 mg for 12 weeks.

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

60

Start Date

August 2015

Completion Date

June 2017

Primary Completion Date

March 2017

Eligibility Criteria

        Inclusion Criteria:

          -  written informed consent male or female aged ≥ 18 years

          -  documentation supporting the diagnosis of acromegaly based on elevated GH and/or IGF-I
             levels due to a pituitary tumor

          -  the patient is treated with lanreotide Autogel or octreotide LAR and PEGV (twice)
             weekly for at least 6 months and has a serum IGF-I level within 120 % of the age
             adjusted normal limits. These patients were previously not controlled by somatostatin
             analogs alone.

          -  female of no childbearing potential or male. No childbearing potential is defined as
             being postmenopausal for at least 1 year, or women with documented infertility
             (natural or acquired) or using two acceptable contraceptive measures, except for oral
             contraceptives.

          -  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. use a condom)
             for the duration of the study

          -  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:

        Patients will not be included in the study if he or she:

          -  has undergone pituitary surgery or radiotherapy within 6 months prior to study entry.

          -  it is anticipated that the patient will receive pituitary surgery or radiotherapy
             during the study.

          -  has a history of hypersensitivity to lanreotide, octreotide or pegvisomant or drugs
             with a similar chemical structure

          -  has been treated with any unlicensed drug within the last 30 days before study entry.

          -  has abnormal hepatic function at study entry (defined as AST, ALT, gGT, alkaline
             phosphatase, or total bilirubin above 3 ULN)

          -  is at risk of pregnancy or is lactating. Females of childbearing potential must
             provide a negative pregnancy test within 5 days before the start of the study and must
             be using contraception. Non-childbearing potential is defined as post-menopause for at
             least one year, surgical sterilization or hysterectomy at least three months before
             the start of the study.

          -  has a history of, or known current problems with alcohol or drug abuse.

          -  has a mental condition rendering the subject unable to understand the nature, scope
             and possible consequences of the study, and/or evidence of an uncooperative attitude.

          -  has abnormal baseline findings, any other medical condition(s) or laboratory findings
             that, in the opinion of the investigator, might jeopardize the subject's safety or
             decrease the chance of obtaining satisfactory data needed to achieve the objective(s)
             of the study.

          -  renal insufficiency, clearance < 50ml/min

          -  poorly controlled diabetes mellitus with an HbA1c > 9.0%

          -  patients with a QTc > 500 ms on the EKG

          -  participation in a clinical trial in the last 6 months
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Sebastian Neggers, MD PhD, , 

Location Countries

Netherlands

Location Countries

Netherlands

Administrative Informations


NCT ID

NCT02668172

Organization ID

NL49517.078.14

Secondary IDs

2014-002219-41

Responsible Party

Principal Investigator

Study Sponsor

Erasmus Medical Center

Collaborators

 Novartis

Study Sponsor

Sebastian Neggers, MD PhD, Principal Investigator, Erasmus MC


Verification Date

August 2016