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)
Acromegaly, GEP-NET
About this trial
This is an interventional treatment trial for Acromegaly
Eligibility Criteria
Main Inclusion Criteria:
For Participants with Acromegaly:
- Treatment with a stable dose of octreotide LAR (≤30 mg dose once in 4 weeks [Q4W] IM) or lanreotide ATG (≤120 mg Q4W as deep SC injection) for at least 2 months as monotherapy for acromegaly treatment prior to entering Run-in (Day -28)
- 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 a stable dose of octreotide LAR (≤ 30 mg dose Q4W IM) or lanreotide ATG (≤ 120 mg Q4W as deep SC injection) for at least 2 months prior to entering Run-in (Day -28)
- 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:
- Left ventricular ejection fraction, left ventricular hypertrophy, ventricular arrhythmias, bradycardia, cardiomyopathy
- Heart failure
- Congenital long QT syndrome or
- Known family history of long QT syndrome or sudden cardiac death
- 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
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), or other investigational agents (within 30 days or 5 half-lives prior to screening, whichever is longer)
- 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.]
Sites / Locations
- Rigshospitalet, Endokrinologisk afdelingRecruiting
- CHU AngersRecruiting
- AP-HP Hopital BicetreRecruiting
- AP-HM - Hôpital de la Conception, Service d'Endocrinologie et Centre de Référence des Maladies Rares de l'hypophyseRecruiting
- CHU Bordeaux - Hôpital Haut-LévêqueRecruiting
- Universitaetsklinikum Bonn, Medizinische Klinik und Poliklinik I,Recruiting
- Medicover Praxis fur NeuroendokrinologieRecruiting
- Hadassah Ein-Karem Medical CenterRecruiting
- Rabin Medical Center, Beilinson Hospital, Clalit Health Services by Rabin Medical Center, Beilinson HospitaRecruiting
- Sheba Medical Center, Endocrine instituteRecruiting
- Tel Aviv Sourasky Medical Center, Institute of Endocrinology, metabolism and hypertensionRecruiting
- Istituto Romagnolo per lo Studio dei Tumori Dino AmadoriRecruiting
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di MilanoRecruiting
- Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro CuoreRecruiting
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Oddzial GliwiceRecruiting
- Uniwersyteckie Centrum Kliniczne im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego w KatowicachRecruiting
- Mazowiecki Szpital Brodnowski - Zespol Oddzialow Chorob Wewnetrznych, Endokrynologii i DiabetologiiRecruiting
- Instituto Português de Oncologia de Lisboa Francisco GentilRecruiting
- Centro Hospitalar Universitário São JoãoRecruiting
- Hospital de la Santa Creu i Sant Pau BarcelonRecruiting
- Hospital Universitario 12 de OctubreRecruiting
- Hospital Universitario Virgen del RocioRecruiting
- University Hospital Coventry, WISDEM Centre, UHCW NHS TrustRecruiting
- Royal Free London NHS Foundation TrustRecruiting
- Cancer Research UK - Christie Hospital Foundation NHS Trust - Dept of Medical Oncology, Christie Hospital NHS Foundation TrustRecruiting
- Cancer Research UK - Christie Hospital Foundation NHS Trust - Endocrinology Department, Endocrinology department, The ChristieRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Cohort A: Participants With Acromegaly
Cohort B: Participants With GEP-NET
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.
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.