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

Status: Terminated
Location: See all (14) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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

Locations
Other Locations
Denmark
Rigshospitalet, Endokrinologisk afdeling
Copenhagen
France
CHU Angers
Angers
AP-HP Hopital Bicetre
Le Kremlin-bicêtre
AP-HM - Hôpital de la Conception, Service d'Endocrinologie et Centre de Référence des Maladies Rares de l'hypophyse
Marseille
Germany
Medicover Praxis fur Neuroendokrinologie
Munich
Israel
Rabin Medical Center, Beilinson Hospital, Clalit Health Services by Rabin Medical Center, Beilinson Hospita
Petah Tikva
Sheba Medical Center, Endocrine institute
Ramat Gan
Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
Milan
Poland
Uniwersyteckie Centrum Kliniczne im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowicach
Katowice
Mazowiecki Szpital Brodnowski - Zespol Oddzialow Chorob Wewnetrznych, Endokrynologii i Diabetologii
Warsaw
Spain
Hospital de la Santa Creu i Sant Pau Barcelon
Barcelona
Hospital Universitario Virgen del Rocio
Seville
United Kingdom
University Hospital Coventry, WISDEM Centre, UHCW NHS Trust
Coventry
Royal Free London NHS Foundation Trust
London
Time Frame
Start Date: 2022-05-18
Completion Date: 2024-12-03
Participants
Target number of participants: 19
Treatments
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.
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.
Sponsors
Leads: Debiopharm International SA

This content was sourced from clinicaltrials.gov