Status:
TERMINATED
A Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Debio 4126 in Participants With Acromegaly or Functioning Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)
Lead Sponsor:
Debiopharm International SA
Conditions:
Acromegaly
GEP-NET
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Main
- 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
- 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
- \[Note: Other inclusion/exclusion criteria mentioned in the protocol may apply.\]
Key Trial Info
Start Date :
May 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 3 2024
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT05364944
Start Date
May 18 2022
End Date
December 3 2024
Last Update
November 17 2025
Active Locations (14)
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1
Rigshospitalet, Endokrinologisk afdeling
Copenhagen, Denmark, 2200
2
CHU Angers
Angers, France, 49933
3
AP-HP Hopital Bicetre
Le Kremlin-Bicêtre, France, 94270
4
AP-HM - Hôpital de la Conception, Service d'Endocrinologie et Centre de Référence des Maladies Rares de l'hypophyse
Marseille, France, 13385