A study on the use of Debio 0123 in combination with Temozolomide in adult patients with recurrent or progressive glioblastoma, as well as on the use of Debio 0123 in combination with Temozolomide and radiotherapy in adult patients with newly diagnosed glioblastoma.
Résumé de l'étude
This is a clinical study on the investigational drug Debio 0123 in combination with the approved drug Temozolomide (TMZ) or with TMZ and radiotherapy in patients with a specific brain tumor called glioblastoma (GBM). The study consists of two phases. In Phase I, different doses are administered to groups of participants to determine the safest dose. Phase II begins after the data from Phase I have been evaluated and a recommended dose has been determined. The main goal of Phase I is to find the safest study treatment and to investigate its effect on participants with GBM. The various treatment combinations of the study are administered to different groups (“arms”) of participants. In Arm A, Debio 0123 is administered in combination with TMZ, in Arm C (and previously Arm B) with TMZ and radiotherapy. The main goal of Phase II is to determine the efficacy of the combination of Debio 0123 and TMZ in the treatment of GBM in a group of participants, the “trial arm,” compared to the results of previous clinical studies on participants whose GBM was treated with standard therapy, the “external control arm.” Debio 0123 is intended to prevent cancer cells from repairing their damaged DNA, thereby helping to kill cancer cells and shrink the tumor. Participants may benefit from the study treatment, but there is no guarantee. The combination of Debio 0123 with TMZ has been tested in animal studies but is being administered to humans for the first time in this study. It cannot be ruled out that the combination treatment may lead to more side effects, which can be mild, severe, and life-threatening, or even lead to death. Treatment with Debio 0123 alone is being evaluated in other clinical studies and is so far considered safe, but the risks and side effects are not yet fully known.
(BASEC)
Intervention étudiée
This is an open-label study, meaning that the study teams, the sponsor, and the participants know the treatment group to which they are assigned and the doses they receive. Participants undergo a screening period of up to 28 days (to determine if the patient can participate in the study), a study treatment (in which the patient receives the study treatments according to the assigned arm), and a post-treatment follow-up. The total duration of the study treatment depends on how participants respond to the treatment.
(BASEC)
Maladie en cours d'investigation
Progressive and newly diagnosed glioblastoma
(BASEC)
1 - Patients are ≥ 18 years old. 2 - Participants agree to provide an archived or fresh tumor sample, if available. Submission of a tumor sample is not required to initiate study treatment. 4 - Bone marrow, liver, and kidney function is adequate: • Absolute neutrophil count (ANC) is ≥ 1500/μl, platelet count ≥ 100,000/μl, and hemoglobin level ≥ 9 g/dl or 5.6 mmol/l. Additionally, no blood transfusions have occurred within the last 2 weeks prior to the start of study treatment. • For participants with liver metastases, values for aspartate aminotransferase (AST) and alanine aminotransferase (ALT) are ≤ 2.5 × the upper limit of normal (ULN) or ≤ 5 × ULN. For participants with liver metastases, values for total bilirubin in serum are ≤ 1.5 × ULN and for alkaline phosphatase (ALP) < 2.5 × ULN or ≤ 5 × ULN. • Calculated creatinine clearance is ≥ 50 ml/minute (according to the Chronic Kidney Disease – Epidemiology Collaboration [CKD EPI] formula). • Coagulation status corresponds to international normalized ratio (INR) or a prothrombin time of ≤ 1.5 × ULN and activated partial thromboplastin time (aPTT) of ≤ 1.5 × ULN. (BASEC)
Critères d'exclusion
1 - History of other malignant diseases that required active treatment within the last 2 years prior to the first dose of study treatment, except for superficial bladder carcinomas, adequately treated low-risk prostate carcinomas under active surveillance, ductal carcinoma in situ or other in situ carcinomas and non-melanocytic skin cancers (basal cell or squamous cell carcinoma) that were treated with curative intent. 2 - Clinically significant gastrointestinal anomalies that would impair the absorption of the drug (e.g., ulcerative diseases, gastrointestinal dysfunctions, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, extensive resection of the small intestine or total gastrectomy or inflammatory bowel diseases). 3 - Infection requiring systemic administration of an antibiotic or antiviral within 1 week prior to the start of study treatment. (BASEC)
Lieu de l’étude
Zurich
(BASEC)
Sponsor
Debiopharm International S.A.
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Orla Duffy-Roger
+4121312011
info-international@clutterdebiopharm.comDebiopharm International S.A./Clinical Department
(BASEC)
Informations scientifiques
non disponible
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale de Zurich
(BASEC)
Date d'approbation du comité d'éthique
28.03.2023
(BASEC)
Identifiant de l'essai ICTRP
non disponible
Titre officiel (approuvé par le comité d'éthique)
A Phase 1/2 open-label study of Debio 0123 in combination with temozolomide in adult participants with recurrent or progressive glioblastoma and of Debio 0123 in combination with temozolomide and radiotherapy in adult participants with newly diagnosed glioblastoma (BASEC)
Titre académique
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Titre public
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Maladie en cours d'investigation
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Intervention étudiée
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Type d'essai
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Plan de l'étude
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Critères d'inclusion/exclusion
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Critères d'évaluation principaux et secondaires
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Date d'enregistrement
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Inclusion du premier participant
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Sponsors secondaires
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Contacts supplémentaires
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ID secondaires
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Résultats-Données individuelles des participants
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Informations complémentaires sur l'essai
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Résultats de l'essai
Résumé des résultats
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Lien vers les résultats dans le registre primaire
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