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Trial · Interventional

Status unknownPhase 4Registry data

Pasireotide LAR and Pegvisomant Study in Acromegaly

Short name PAPE

NCTNCT02668172 (opens ClinicalTrials.gov in a new tab)Other idNL49517.078.14Other id2014-002219-41Other idNTR5282Other id2014

Overview

Status
Status unknown
Phase
Phase 4
Enrollment
60 participants (actual)
Sponsor
Erasmus Medical Center · Other
Design
Not randomized · Open label (no masking)
Countries
1 country

Netherlands

Start
Aug 2015
Primary completion
Mar 2017 (estimated)
Completion
Jun 2017 (estimated)
First posted
29 Jan 2016 (estimated)
Last update posted
3 Aug 2016 (estimated)
Conditions
Acromegaly

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2015201620172018
  1. Ph 4

    PAPE

    NCT02668172

    Aug 2015 to est. Jun 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Pasireotide LAR 60 mgDrug
  • PegvisomantDrug

Arms3

  • Experimental

    Pasireotide LAR 60 mg monotherapy week 12

    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.

  • Experimental

    Pasireotide LAR 60 mg and Pegvisomant week 12

    When IGF-I rises above the adjusted normal limits after 12 weeks (run-in period), these subjects will switch their LA-SSA to Pasireotide LAR 60 mg every 4 weeks and continue with the reduced PEGV dose of the run-in period, for the remaining 12 weeks.

  • Experimental

    Pasireotide LAR 60 mg and Pegvisomant week 24

    Between week 12 and 24 dose adaptations of PEGV are not permitted unless IGF-I drops below the age adjusted normal limits, then the dose of PEGV will be decreased stepwise with 20 mg weekly until IGF-I is within the age adjusted normal limits. At week 24, efficacy will be assessed, as the number of patients with a normal IGF-I in the two different groups; the combination Pasireotide LAR 60 mg / PEG V dose and monotherapy Pasireotide LAR 60 mg. From week 24 patients will continue with Pasireotide LAR 60 mg monotherapy, or Pasireotide LAR will be combined with 50% of the original dose of PEGV, or with an increasing dose of PEGV every 8 weeks depending on the treatment arm.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 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

    Time frame · 24 weeks

Secondary outcomes(10)
  1. The proportion of patients with normalized IGF1 levels after 48 weeks of pasireotide LAR monotherapy

    Time frame · 48 weeks

  2. The proportion of patients with normalized IGF1 levels after 48 weeks combination treatment of pasireotide LAR with weekly pegvisomant.

    Time frame · 48 weeks

  3. The necessary dose of pegvisomant during combination treatment of pasireotide LAR with pegvisomant in patients with an IGF-I level within the age adjusted normal limits

    Time frame · 48 weeks

  4. Change in tumor volume by pituitary MRI

    Time frame · Baseline and 48 weeks

  5. Tolerability and safety profile of pasireotide Long Acting Release (LAR) monotherapy

    Time frame · 48 weeks

    Registry description

    Toxicity will be assessed using the National Cancer Institute-Common Toxicology Criteria Adverse Events version 4 (NCI-CTCAE v.4.03) and for laboratory assessments that include biochemistry, hematology, urinalysis; special safety assessments that include the regular monitoring and recording of blood glucose, insulin, HbA1c, GH and IGF-1, thyroid and liver function tests, gallbladder examinations and ECGs. Concomitant medications/Significant nondrug therapies will be assessed from study enrollment until the safety follow-up.

  6. Tolerability and safety profile of pasireotide LAR and pegvisomant combination therapy

    Time frame · 48 weeks

    Registry description

    Toxicity will be assessed using the National Cancer Institute-Common Toxicology Criteria Adverse Events version 4 (NCI-CTCAE v.4.03) and for laboratory assessments that include biochemistry, hematology, urinalysis; special safety assessments that include the regular monitoring and recording of blood glucose, insulin, HbA1c, and IGF-1, thyroid and liver function tests, gallbladder examinations and ECGs. Concomitant medications/Significant nondrug therapies will be assessed from study enrollment until the safety follow-up.

  7. Evaluation of long term effect of pasireotide LAR with or without pegvisomant on AcroQol, PASQ and signs and symptoms of acromegaly

    Time frame · Change in scores as measured by AcroQoL from baseline to week 48

    Registry description

    AcroQol is quality of life questionnaire specifically designed for acromegaly

  8. Evaluation of long term effect of pasireotide LAR with or without pegvisomant on AcroQol, PASQ and signs and symptoms of acromegaly

    Time frame · Change in scores as measured by PASQ from baseline to week 48

    Registry description

    PASQ are questionnaire for the disease specific symptoms

  9. Evaluation of long term effect of pasireotide LAR with or without pegvisomant on AcroQol, PASQ and signs and symptoms of acromegaly

    Time frame · Description of signs and symptoms of acromegaly

  10. Evaluation of body composition by Dual-energy X-ray Absorptiometry (DEXA) scan

    Time frame · baseline and 48 weeks

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

0 studies on this page

Indexing hint: Clinical trial · 2018

Efficacy and Safety of Switching to Pasireotide in Patients With Acromegaly Controlled With Pegvisomant and First-Generation Somatostatin Analogues (PAPE Study).

Muhammad et al. 2018The Journal of clinical endocrinology and metabolismcited by 62

PMID 29155991DOI 10.1210/jc.2017-02017PUB-29155991

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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