DRUG
Pasireotide LAR 60 mg
as mono-therapy or in combination with pegvisomant
Status
Unknown
Phase
Phase 4
Enrollment
60
Locations
1
Results
Not posted
Publications
1
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.
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.
Interventions
DRUG
as mono-therapy or in combination with pegvisomant
DRUG
only in combination with pasireotide LAR
Timeline
First posted
Jan 29, 2016
Study start
Aug 2015
Primary completion
Mar 2017
Study completion
Jun 2017
Results posted
Not reported
Registry updated
Aug 3, 2016
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
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
Time frame · 48 weeks
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.
Tolerability and safety profile of pasireotide LAR and pegvisomant combination therapy
Time frame · 48 weeks
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.
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
AcroQol is quality of life questionnaire specifically designed for acromegaly
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
PASQ are questionnaire for the disease specific symptoms
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
Eligibility
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
Study locations
Netherlands. Showing up to 24 locations stored in the fast local snapshot.
Erasmus Medical Center
Rotterdam, South Holland, Netherlands
Related trials
Novartis · Somatostatin Receptor Positive (SSTR+) · Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET)
Phase 3
Recruiting
240
2026-04
Memorial Sloan Kettering Cancer Center · Prolactin-Producing Pituitary Tumor
Phase 2
Recruiting
10
2026-03
RECORDATI GROUP · Pharmacokinetics · Safety
Phase 1
Completed
40
2026-02
Advanced Accelerator Applications · Gastro-enteropancreatic Neuroendocrine Tumor
Phase 3
Active, not recruiting
226
2026-01
Hospices Civils de Lyon · Enterostomy
Phase 2
Completed
57
2025-12
RECORDATI GROUP · Post-Bariatric Hypoglycemia
Phase 2
Active, not recruiting
93
2025-09
Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Acromegaly Due to Pituitary Adenoma · Acromegaly
Not applicable
Recruiting
120
2025-09
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Castrate Resistant Prostate Cancer · Chemotherapy Naive Prostate Cancer
Phase 2
Terminated
6
2025-04
Related PeptideStat pages
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.