- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05364944
A Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Debio 4126 in Participants With Acromegaly or Functioning Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) (OXTEND-01)
February 26, 2024 updated by: Debiopharm International SA
A Phase 1b Study in Patients With Acromegaly or Functioning Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) to Characterize the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Debio 4126, a 12-week Prolonged-release Octreotide Formulation
This is an open-label, single treatment arm, multicenter study to assess the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of Debio 4126 in the treatment of participants with Acromegaly or Functioning Gastroenteropancreatic Neuroendocrine tumors (GEP-NETs).
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Debiopharm International S.A
- Phone Number: +41 21 321 01 11
- Email: clinicaltrials@debiopharm.com
Study Locations
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Copenaghen, Denmark, 2200
- Rigshospitalet, Endokrinologisk afdeling
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Angers, France, 49933
- CHU Angers
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Le Kremlin-bicetre, France, 94270
- AP-HP Hôpital Bicêtre
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Marseille, France, 13385
- AP-HM - Hôpital de la Conception, Service d'Endocrinologie et Centre de Référence des Maladies Rares de l'hypophyse
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Munich, Germany, 81667
- Medicover Praxis fur Neuroendokrinologie
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Petach Tikva, Israel, 49100
- Rabin Medical Center, Beilinson Hospital, Clalit Health Services by Rabin Medical Center, Beilinson Hospita
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Ramat Gan, Israel, 5265601
- Sheba Medical Center, Endocrine institute
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Milano, Italy, 20122
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
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Katowice, Poland, 40-514
- Uniwersyteckie Centrum Kliniczne im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowicach
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Warszawa, Poland, 03-242
- Mazowiecki Szpital Brodnowski - Zespol Oddzialow Chorob Wewnetrznych, Endokrynologii i Diabetologii
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Barcelona, Spain, 08041
- Hospital de la Santa Creu i Sant Pau Barcelon
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Sevilla, Spain, 41013
- Hospital Universitario Virgen del Rocio
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Coventry, United Kingdom, CV2 2DX
- University Hospital Coventry, WISDEM Centre, UHCW NHS Trust
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Main Inclusion Criteria:
For Participants with Acromegaly:
- Treatment with octreotide LAR (≤30 mg dose once in 4 weeks [Q4W] IM) or lanreotide ATG (≤120 mg Q4W or 120 mg once in 6 weeks [Q6W] to once in 8 weeks [Q8W] as deep SC injection) for at least 6 months overall, and for at least 2 months at a stable dose as monotherapy for acromegaly treatment prior to entering Run-in (Day -28). Octreotide doses of 10, 20, and 30 mg are considered similar to lanreotide doses of 60, 90, and 120 mg. Thus, a switch between similar doses of the two products will be considered as the patient remaining on a stable dose, unless due to efficacy or safety
- Diagnosis of acromegaly by historical evidence of (persistent or recurrent) acromegaly will be carried out
- IGF-1 ≤1.3 x upper limit of normal (ULN) assessed centrally at screening
For Participants with GEP-NETs:
- Treatment with octreotide LAR (≤ 30 mg dose Q4W IM) or lanreotide ATG (≤ 120 mg Q4W or 120 mg Q6W to Q8W as deep SC injection) for at least 6 months overall, and for at least 2 months at a stable dose as monotherapy for study disease treatment prior to entering Run-in (Day -28). Octreotide doses of 10, 20, and 30 mg are considered similar to lanreotide doses of 60, 90, and 120 mg. Thus, a switch between similar doses of the two products will be considered as the participant remaining on a stable dose, unless due to efficacy or safety
- Participants with functioning, well-differentiated (Grade 1 or Grade 2) GEP-NET with symptoms of carcinoid syndrome which are controlled by Sandostatin LAR, Somatuline ATG, or equivalent medications; sporadic use of rescue medication for symptom control, e.g., bowel movements and/or flushing, is allowed
Main Exclusion Criteria:
For Participants with Acromegaly and GEP-NETs:
- Known ongoing gallbladder or bile duct disease or acute or chronic pancreatitis
- Hypothyroidism not adequately treated with thyroid hormone replacement therapy
- Diabetic participants whose blood glucose is poorly controlled despite adequate therapy, as evidenced by glycated hemoglobin (HbA1c) >8.0% at screening
Cardiology:
- Known left ventricular ejection fraction <50%, left ventricular hypertrophy, ventricular arrhythmias, bradycardia (heart rate <50 beats per minute [bpm]), cardiomyopathy
- New York Heart Association Class ≥3 heart failure
- Congenital long QT syndrome or
- Known family history of long QT syndrome or sudden cardiac death before the age of 50
- Symptomatic Pulmonary embolism
- QT interval corrected for heart rate according to Fridericia's formula (QTcF) at screening >450 milliseconds (msec) for males and >470 msec for females, based on the average of a triplicate ECG
For Participants with Acromegaly:
- Participants who received pituitary irradiation <2 years prior to enrollment as stereotactic radiotherapy or <3 years prior to enrollment for conventional radiotherapy
- Participants who received medical treatment with pasireotide (within 6 months prior to screening), pegvisomant (within 3 months prior to screening), dopamine agonists (within 3 months prior to screening)
- Participants who have undergone pituitary surgery within 6 months prior to screening
For Participants with GEP-NETs:
- Participants with short-bowel syndrome
- Participants with poorly differentiated neuroendocrine carcinoma and/or high-grade neuroendocrine carcinoma
- Participants who have received any previous therapy with interferons, targeted therapies (e.g., everolimus, sunitinib, bevacizumab), chemotherapy or other anti-neoplastic systemic therapies administered for more than 1 month and within 12 weeks prior to the start of the Run-in period
- Participants having history of hepatic embolization, hepatic arterial chemoembolization, and/or selective internal radiation (SIR) therapy within less than 6 months prior to screening
- Participants who have received Peptide receptor radionuclide therapy (PRRT) therapy during the last 12 months prior to screening
[Note: Other inclusion/exclusion criteria mentioned in the protocol may apply.]
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Cohort A: Participants With Acromegaly
Participants will receive Sandostatin Long-acting repeatable (LAR) or Somatuline Autogel (ATG) (or equivalent formulations of octreotide/lanreotide) in Run-in Period and further will receive Debio 4126 in this group.
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Intramuscular (IM) injection
Sandostatin LAR will be administered as IM injection as pre-study treatment dose prior to Debio 4126 administration
Other Names:
Somatulin ATG will be administered as deep subcutaneous (SC) injection as pre-study treatment dose prior to Debio 4126 administration
Other Names:
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Experimental: Cohort B: Participants With GEP-NET
Participants will receive Sandostatin LAR or Somatuline ATG (or equivalent formulations of octreotide/lanreotide) in Run-in Period and further will receive Debio 4126 in this group.
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Intramuscular (IM) injection
Sandostatin LAR will be administered as IM injection as pre-study treatment dose prior to Debio 4126 administration
Other Names:
Somatulin ATG will be administered as deep subcutaneous (SC) injection as pre-study treatment dose prior to Debio 4126 administration
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Plasma Concentration of Debio 4126 in Acromegaly and GEP-NET Participants
Time Frame: Predose at Days -28 to -7; Postdose at multiple timepoints from Day 1 to Day 337
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The PK of Debio 4126 will be evaluated in plasma.
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Predose at Days -28 to -7; Postdose at multiple timepoints from Day 1 to Day 337
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Assessment of Ratio of Accumulation (Rac) of Octreotide in Plasma After Repeated Administration of Debio 4126 in Acromegaly and GEP-NET Participants
Time Frame: Predose at Days -28 to -7; Postdose at multiple timepoints from Day 1 to Day 337
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Predose at Days -28 to -7; Postdose at multiple timepoints from Day 1 to Day 337
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Insulin-Like Growth Factor 1 (IGF-1) and Growth Hormone (GH) Levels in Acromegaly Participants
Time Frame: Baseline up to Week 48
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The blood samples will be collected to assess changes in the levels of IGF-1 (in µg/L) and GH (in µg/L).
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Baseline up to Week 48
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Number of Participants With Carcinoid Syndrome Symptoms and use of Rescue Medication for Symptom Control in GEP-NET Participants
Time Frame: Baseline up to Week 48
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Baseline up to Week 48
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Safety and Tolerability of Debio 4126 as Assessed by Number of Participants With At Least one Treatment Emergent Adverse Events (TEAE) in Acromegaly and GEP-NET Participants
Time Frame: Up to Week 65
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Up to Week 65
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Local Tolerability of Debio 4126 as Assessed by Pain at Injection Site Based on Pain Visual Analog Scale (VAS) Score in Acromegaly and GEP-NET Participants
Time Frame: Up to Week 65
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Pain VAS scale score will be assessed on 4-point rating scale, where 0=absent and 3=severe.
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Up to Week 65
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 18, 2022
Primary Completion (Estimated)
November 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
May 4, 2022
First Submitted That Met QC Criteria
May 4, 2022
First Posted (Actual)
May 6, 2022
Study Record Updates
Last Update Posted (Actual)
February 28, 2024
Last Update Submitted That Met QC Criteria
February 26, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Endocrine System Diseases
- Musculoskeletal Diseases
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Hypothalamic Diseases
- Bone Diseases
- Bone Diseases, Endocrine
- Hyperpituitarism
- Pituitary Diseases
- Acromegaly
- Neuroendocrine Tumors
- Antineoplastic Agents
- Gastrointestinal Agents
- Antineoplastic Agents, Hormonal
- Octreotide
- Lanreotide
Other Study ID Numbers
- Debio 4126-102
- 2021-005035-23 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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