Status unknownNCT02668172PAPEUpdated Aug 3, 2016

Pasireotide LAR and Pegvisomant Study in Acromegaly

A Phase 4 interventional study of Pasireotide LAR 60 mg and Pegvisomant in Acromegaly, sponsored by Erasmus Medical Center. Status unknown at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-08-03.

Sponsored by Erasmus Medical Center · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2016), so the status shown — last known as Active, not recruiting — may be out of date.

Phase: Phase 4
Study type: Interventional
Enrollment: 60
Allocation: Non-randomized
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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.

Conditions studied

Acromegaly

Browse trials for

Acromegaly 196

Keywords

pegvisomant
pasireotide LAR
long acting somatostatin analogues

In context

Acromegaly

196 studies on the registry are indexed under Acromegaly; 18 are open to participants now.

This study's enrollment of 60 is above the median of 43 across 115 interventional studies indexed under Acromegaly.

Browse Acromegaly studies →

Lead sponsor

Erasmus Medical Center is the lead sponsor of 466 studies on the registry; 179 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 60 participants (actual)

Study arms

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.
Drug: Pasireotide LAR 60 mg
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.
Drug: Pasireotide LAR 60 mg · Drug: Pegvisomant
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.
Drug: Pasireotide LAR 60 mg · Drug: Pegvisomant

Interventions

DrugPasireotide LAR 60 mg
as mono-therapy or in combination with pegvisomant
Also known as: Signifor, SOM230
DrugPegvisomant
only in combination with pasireotide LAR
Also known as: Somavert

What researchers measure

Primary outcomes

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

The proportion of patients with normalized IGF1 levels after 48 weeks of pasireotide LAR monotherapy
Time frame: 48 weeks
The proportion of patients with normalized IGF1 levels after 48 weeks combination treatment of pasireotide LAR with weekly pegvisomant.
Time frame: 48 weeks
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
Change in tumor volume by pituitary MRI
Time frame: Baseline and 48 weeks
Tolerability and safety profile of pasireotide Long Acting Release (LAR) monotherapy
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.
Time frame: 48 weeks
Tolerability and safety profile of pasireotide LAR and pegvisomant combination therapy
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.
Time frame: 48 weeks
Evaluation of long term effect of pasireotide LAR with or without pegvisomant on AcroQol, PASQ and signs and symptoms of acromegaly
AcroQol is quality of life questionnaire specifically designed for acromegaly
Time frame: Change in scores as measured by AcroQoL from baseline to week 48
Evaluation of long term effect of pasireotide LAR with or without pegvisomant on AcroQol, PASQ and signs and symptoms of acromegaly
PASQ are questionnaire for the disease specific symptoms
Time frame: Change in scores as measured by PASQ from baseline to week 48
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
Evaluation of body composition by Dual-energy X-ray Absorptiometry (DEXA) scan
Time frame: baseline and 48 weeks

Study locations

1 site

Erasmus Medical Center
Rotterdam, South Holland 3000CA, Netherlands

References and documents

Publications

Muhammad A, van der Lely AJ, Delhanty PJD, Dallenga AHG, Haitsma IK, Janssen JAMJL, Neggers SJCMM. Efficacy and Safety of Switching to Pasireotide in Patients With Acromegaly Controlled With Pegvisomant and First-Generation Somatostatin Analogues (PAPE Study). J Clin Endocrinol Metab. 2018 Feb 1;103(2):586-595. doi: 10.1210/jc.2017-02017. PubMed 29155991 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 3, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02668172
Lead sponsor: Erasmus Medical Center
Collaborators: Novartis
Responsible party: s neggers (Consultant endocrinology, Erasmus Medical Center) — Principal investigator
First posted: Jan 29, 2016
Start date: Aug 2015
Primary completion: Mar 2017 (estimated)
Completion: Jun 2017 (estimated)
Last update: Aug 3, 2016

Study contacts

Sebastian Neggers, MD PhD

principal investigator · Erasmus Medical Center

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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