A trial to assess the long-term safety of octreotide subcutaneous depot in patients with acromegaly

Phase 3

Completed

• Conditions: Acromegaly

• Registration Number: 2024-510667-33-00
• Lead Sponsor: Camurus AB

Brief Summary

Main part of the trail: To assess the overall safety and tolerability of CAM2029

Extension part of the trial: To assess the overall safety and tolerability of CAM2029

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-04-17
• Last Update Posted: 2025-02-04

Recruitment & Eligibility

• Status: Ended
• Sex: Not specified
• Target Recruitment: 35

Inclusion Criteria

Main part of the trail: Male or female patients > =18 years at screening

Main part of the trail: Able to provide written informed consent to participate in the trial

Main part of the trail: Diagnosis of acromegaly by historical evidence (persistent or recurrent) acromegaly

Main part of the trail: Treatment with a stable dose of octreotide LAR or lanreotide ATG for at least 3 months as monotherapy prior to screening

Main part of the trail: IGF-1 levels >1xULN and ≤2.0xULN at screening (adjusted for age and sex; mean value of the first measurement at screening and the second measurement at 2 weeks before Day 1) or IGF-1 levels <=1xULN at screening (adjusted for age and sex; value of the first measurement at screening and the second measurement at 2 weeks before Day 1) either without prior pituitary radiotherapy or with prior pituitary radiotherapy

Main part of the trail: Adequate liver, pancreatic, renal and bone marrow functions

Main part of the trail: Normal ECG

Extension part of the trial: Continuation Criteria for Patients who Continue Directly to the Extension Part of the Trial: Patients who continue directly from the main part of the trial must complete treatment with CAM2029 in the main part of the trial, attend the Week 52 visit, and provide written informed consent to continue treatment in the extension part of the trial before treatment can be continued.

Extension part of the trial: Main Inclusion Criteria for Re-invited Patients: Completed treatment with CAM2029 in the main part of the trial and attended the Week 52 visit. Adequate liver, pancreatic and renal functions. Normal ECG.

Exclusion Criteria

Main part of the trail: For roll-over patients from trial HS-18-633: Unresolved, drug-related serious adverse event (SAE) from the preceding trial (HS-18-633)

Main Exclusion Criteria for Re-invited Patients -Extension Part of the Trial: Receiving treatments (other than treatments for acromegaly) known to affect GH or IGF-1 concentration. Patients who have undergone major surgery/surgical therapy (including pituitary surgery) for any cause within 1 month prior to screening. Patients who have received pituitary irradiation since the end of the main part of the trial. Patients with poorly controlled diabetes mellitus (HbA1c >8.0%).

Main part of the trail: For roll-over patients from trial HS-18-633: Patients with a clinically significant or unstable medical or surgical condition that may preclude safe and complete trial participation

Main part of the trail: For new patients: Have received medical treatment for acromegaly with pasireotide (within 6 months prior to screening), pegvisomant (within 3 months prior to screening), dopamine agonists (within 3 months prior to screening) or other investigational agents (within 30 days or 5 half-lives prior to screening [whichever is longer])

Main part of the trail: For new patients: Patients who usually take octreotide LAR or lanreotide ATG less frequently than every 4 weeks (e.g. every 6 weeks or 8 weeks)

Main part of the trail: For new patients: Patients with compression of the optic chiasm causing any visual field defect for whom surgical intervention is indicated

Main part of the trail: For new patients: Patients who have undergone major surgery/surgical therapy for any cause within 1 month prior to screening

Main part of the trail: For new patients: Patients who have undergone pituitary surgery within 6 months prior to screening

Main part of the trail: For new patients: Patients who have received prior pituitary irradiation within 3 years prior to screening

Main part of the trail: For new patients: Patients with poorly controlled diabetes mellitus (hemoglobin A1c [HbA1c] >8.0%)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main part and Extension part of the trial: Characterization of adverse events (AEs)		Main part and Extension part of the trial: Characterization of adverse events (AEs)

Secondary Outcome Measures

Name	Time	Method
Main part of the trail: Proportion of patients with mean IGF-1 levels ≤1 x upper limit of normal (ULN) and <1.3xULN at Week 50 and Week 52 (average of the 2 measurements)		Main part of the trail: Proportion of patients with mean IGF-1 levels ≤1 x upper limit of normal (ULN) and <1.3xULN at Week 50 and Week 52 (average of the 2 measurements)
Main part of the trail: Proportion of patients with mean GH levels <2.5 μg/L and <5.0 μg/L at Week 52		Main part of the trail: Proportion of patients with mean GH levels <2.5 μg/L and <5.0 μg/L at Week 52
Main part of the trail: Proportion of patients/partners declared competent by healthcare professional to administer CAM2029		Main part of the trail: Proportion of patients/partners declared competent by healthcare professional to administer CAM2029
Main part of the trail: Octreotide plasma concentrations over time		Main part of the trail: Octreotide plasma concentrations over time
Main part of the trail: Treatment Satisfaction Questionnaire for Medication (TSQM) scores over time using all 4 domains of TSQM (effectiveness, side effects, convenience, and satisfaction)		Main part of the trail: Treatment Satisfaction Questionnaire for Medication (TSQM) scores over time using all 4 domains of TSQM (effectiveness, side effects, convenience, and satisfaction)
Main part of the trail: Patient satisfaction scale scores at Week 24 and Week 52		Main part of the trail: Patient satisfaction scale scores at Week 24 and Week 52
Main part of the trail: Change from baseline in Acromegaly Quality of Life Questionnaire (AcroQoL) and EuroQoL 5-dimension 5-level (EQ-5D-5L) scores		Main part of the trail: Change from baseline in Acromegaly Quality of Life Questionnaire (AcroQoL) and EuroQoL 5-dimension 5-level (EQ-5D-5L) scores
Extension part of the trial: IGF-1 levels over time		Extension part of the trial: IGF-1 levels over time
Extension part of the trial: GH levels over time		Extension part of the trial: GH levels over time
Extension part of the trial: TSQM scores over time using all 4 domains of TSQM (effectiveness, side effects, convenience, and satisfaction)		Extension part of the trial: TSQM scores over time using all 4 domains of TSQM (effectiveness, side effects, convenience, and satisfaction)
Extension part of the trial: AcroQoL, EQ-5D-5L and Short Form-36 (SF-36) scores over time		Extension part of the trial: AcroQoL, EQ-5D-5L and Short Form-36 (SF-36) scores over time
Extension part of the trial: Work Productivity and Activity Impairment (WPAI) scores over time		Extension part of the trial: Work Productivity and Activity Impairment (WPAI) scores over time
Extension part of the trial: Laboratory values, vital signs, ECG readings and gallbladder imaging over time		Extension part of the trial: Laboratory values, vital signs, ECG readings and gallbladder imaging over time

Trial Locations

Locations (19)

Medical Center - University Of Freiburg; 🇩🇪 Freiburg Im Breisgau, Germany

Klinikum der Universitaet Muenchen AöR; 🇩🇪 Munich, Germany

Medicover Medizin gGmbH; 🇩🇪 Munich, Germany

Medicover GmbH; 🇩🇪 Oldenburg, Germany

Central Hospital Of Northern Pest Military Hospital; 🇭🇺 Budapest VI, Hungary

University Of Szeged; 🇭🇺 Szeged, Hungary

Fondazione Policlinico Universitario Agostino Gemelli IRCCS; 🇮🇹 Rome, Italy

Azienda Ospedaliera Universitaria Federico II Di Napoli; 🇮🇹 Naples, Italy

Azienda Ospedale-Universita Padova; 🇮🇹 Padova, Italy

IRCCS Ospedale Policlinico San Martino; 🇮🇹 Genoa, Italy

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Medical Center - University Of Freiburg

🇩🇪Freiburg Im Breisgau, Germany

Jochen Seufert

Site contact

+4976127034200

jochen.seufert@uniklinik-freiburg.de