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)

  • STATUS
    Recruiting
  • End date
    Feb 4, 2025
  • participants needed
    30
  • sponsor
    Debiopharm International SA
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Updated on 4 April 2023
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octreotide
lanreotide
somatuline
sandostatin
carcinoid syndrome
igf1

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 Acromegaly or Functioning Gastroenteropancreatic Neuroendocrine tumors (GEP-NETs).

Details
Condition Acromegaly, GEP-NET
Treatment Sandostatin LAR, Debio 4126, Somatuline ATG
Clinical Study IdentifierNCT05364944
SponsorDebiopharm International SA
Last Modified on4 April 2023

Eligibility

 Yes No Not Sure

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

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.]
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