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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)

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ClinicalTrials.gov Identifier: NCT05364944
Recruitment Status : Recruiting
First Posted : May 6, 2022
Last Update Posted : November 29, 2022
Sponsor:
Information provided by (Responsible Party):
Debiopharm International SA

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

Condition or disease Intervention/treatment Phase
Acromegaly GEP-NET Drug: Debio 4126 Drug: Sandostatin LAR Drug: Somatuline ATG Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 18, 2022
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : February 2025


Arm Intervention/treatment
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.
Drug: Debio 4126
Intramuscular (IM) injection

Drug: Sandostatin LAR
Sandostatin LAR will be administered as IM injection as pre-study treatment dose prior to Debio 4126 administration
Other Name: Octreotide acetate

Drug: Somatuline ATG
Somatulin ATG will be administered as deep subcutaneous (SC) injection as pre-study treatment dose prior to Debio 4126 administration
Other Name: Lanreotide acetate

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.
Drug: Debio 4126
Intramuscular (IM) injection

Drug: Sandostatin LAR
Sandostatin LAR will be administered as IM injection as pre-study treatment dose prior to Debio 4126 administration
Other Name: Octreotide acetate

Drug: Somatuline ATG
Somatulin ATG will be administered as deep subcutaneous (SC) injection as pre-study treatment dose prior to Debio 4126 administration
Other Name: Lanreotide acetate




Primary Outcome Measures :
  1. Plasma Concentration of Debio 4126 in Acromegaly and GEP-NET Participants [ Time Frame: Predose at Days -28 to -7; Postdose at multiple timepoints from Day 1 to Day 337 ]
    The PK of Debio 4126 will be evaluated in plasma.


Secondary Outcome Measures :
  1. Assessment of Ratio of Accumulation (Rac) of Octreotide in Plasma After Repeated Administration of Debio 4126 in Acromegaly and GEP-NET Participants [ Time Frame: Predose at Days -28 to -7; Postdose at multiple timepoints from Day 1 to Day 337 ]
  2. Safety and Tolerability of Debio 4126 as Assessed by Number of Participants With At Least one Treatment Emergent Adverse Events (TEAE) in Acromegaly and GEP-NET Participants [ Time Frame: Up to Week 61 ]
  3. Local Tolerability of Debio 4126 as Assessed by Pain at Injection Site Based on Pain Visual Analog Scale (VAS) Score in Acromegaly and GEP-NET Participants [ Time Frame: Up to Week 61 ]
    Pain VAS scale score will be assessed on 4-point rating scale, where 0=absent and 3=severe.

  4. Insulin-Like Growth Factor 1 (IGF-1) and Growth Hormone (GH) Levels in Acromegaly Participants [ Time Frame: Baseline up to Week 48 ]
    The blood samples will be collected to assess changes in the levels of IGF-1 (in µg/L) and GH (in µg/L).

  5. Number of Participants With Carcinoid Syndrome Symptoms and use of Rescue Medication for Symptom Control in GEP-NET Participants [ Time Frame: Baseline up to Week 48 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

    1. Left ventricular ejection fraction, left ventricular hypertrophy, ventricular arrhythmias, bradycardia, cardiomyopathy
    2. Heart failure
    3. Congenital long QT syndrome or
    4. Known family history of long QT syndrome or sudden cardiac death
    5. 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

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.]


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05364944


Contacts
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Contact: Debiopharm International S.A +41 21 321 01 11 clinicaltrials@debiopharm.com

Locations
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Sponsors and Collaborators
Debiopharm International SA
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Responsible Party: Debiopharm International SA
ClinicalTrials.gov Identifier: NCT05364944    
Other Study ID Numbers: Debio 4126-102
2021-005035-23 ( EudraCT Number )
First Posted: May 6, 2022    Key Record Dates
Last Update Posted: November 29, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Acromegaly
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Octreotide
Lanreotide
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents