A Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Debio 4126 in Participants With Acromegaly or Functioning Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)

Launched by DEBIOPHARM INTERNATIONAL SA · May 4, 2022

Keywords

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Gender

ALL

Eligibility criteria

• 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:
• • 1. Known left ventricular ejection fraction \<50%, left ventricular hypertrophy, ventricular arrhythmias, bradycardia (heart rate \<50 beats per minute \[bpm\]), cardiomyopathy
• • 2. New York Heart Association Class ≥3 heart failure
• • 3. Congenital long QT syndrome or
• • 4. Known family history of long QT syndrome or sudden cardiac death before the age of 50
• • 5. Symptomatic Pulmonary embolism
• • 6. 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
• • \[Note: Other inclusion/exclusion criteria mentioned in the protocol may apply.\]