Informations générales (source: ClinicalTrials.gov)
A Phase I, Open-label, Parallel Group Study to Investigate Olaparib Safety and Tolerability, Efficacy and Pharmacokinetics in Paediatric Patients With Solid Tumours
Interventional
Phase 1
AstraZeneca (Voir sur ClinicalTrials)
janvier 2020
décembre 2025
19 décembre 2024
A study to find out whether olaparib is safe and well tolerated when administered to
children and adolescents with solid tumours.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 04/12/2024 12:44:21 | Contact (sur clinicalTrials) | |||
| CLCC INSTITUT GUSTAVE ROUSSY | Samuel ABBOU | 22/02/2024 16:21:43 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Research Site - 13385 - Marseille - France | Contact (sur clinicalTrials) | ||||
| Research Site - 31300 - Toulouse - France | Contact (sur clinicalTrials) | ||||
| Research Site - 59000 - Lille - France | Contact (sur clinicalTrials) | ||||
| Research Site - 75005 - Paris - France | Contact (sur clinicalTrials) | ||||
| Research Site - 94805 - Villejuif Cedex - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Provision of Informed Consent
- Male and female patients who are ≥6 months to <18 years of age at consent
- Pathologically confirmed relapsed or refractory solid or primary CNS tumours
(excluding lymphoid malignancies), with a HRR deficiency/gene mutation, and for whom
there are no standard treatment options. Eligible patients may include but not be
limited to those with osteosarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft
tissue sarcoma, Ewing Sarcoma, neuroblastoma, medulloblastoma and glioma
- For dose finding phase only: recruitment will be open to all patients with HRR
deficiency, based on a local test. For the signal identification phase: recruitment
will be open only to patients with documented evidence of a deleterious or suspected
deleterious germline or tumour HRR gene mutation that meets the AZ HRR rules
- A formalin fixed, paraffin embedded (FFPE) tumour sample from the primary cancer
(all patients) suitable for central HRR testing and a blood sample (patients ≥2
years old) for central germline BRCA testing must be provided for each patient
- For all non-neuroblastoma tumours, patients must have at least 1 radiographical
assessable lesion (measurable and/or non-measurable). For neuroblastoma tumours,
patients must have radiographical assessable disease with at least 1 lesion
(measurable and/or non measurable) OR disease evidenced by uptake of
meta-iodobenzylguanidine- (MIBG) or fluorodeoxyglucose positron emission tomography
(FDG-PET) scans
- Adequate performance status, organ, and marrow function and adequate weight to
obtain blood samples for both safety laboratory assessments and PK analysis.
- Ability to swallow tablets
Key
- Provision of Informed Consent
- Male and female patients who are ≥6 months to <18 years of age at consent
- Pathologically confirmed relapsed or refractory solid or primary CNS tumours
(excluding lymphoid malignancies), with a HRR deficiency/gene mutation, and for whom
there are no standard treatment options. Eligible patients may include but not be
limited to those with osteosarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft
tissue sarcoma, Ewing Sarcoma, neuroblastoma, medulloblastoma and glioma
- For dose finding phase only: recruitment will be open to all patients with HRR
deficiency, based on a local test. For the signal identification phase: recruitment
will be open only to patients with documented evidence of a deleterious or suspected
deleterious germline or tumour HRR gene mutation that meets the AZ HRR rules
- A formalin fixed, paraffin embedded (FFPE) tumour sample from the primary cancer
(all patients) suitable for central HRR testing and a blood sample (patients ≥2
years old) for central germline BRCA testing must be provided for each patient
- For all non-neuroblastoma tumours, patients must have at least 1 radiographical
assessable lesion (measurable and/or non-measurable). For neuroblastoma tumours,
patients must have radiographical assessable disease with at least 1 lesion
(measurable and/or non measurable) OR disease evidenced by uptake of
meta-iodobenzylguanidine- (MIBG) or fluorodeoxyglucose positron emission tomography
(FDG-PET) scans
- Adequate performance status, organ, and marrow function and adequate weight to
obtain blood samples for both safety laboratory assessments and PK analysis.
- Ability to swallow tablets
Key
- Patients with MDS/AML or with features suggestive of MDS/AML
- Patients unable to swallow orally administered medication
- Unresolved toxicity from previous anticancer therapy
- Unstable or untreated CNS disease (i.e., symptomatic uncontrolled brain metastases
or untreated spinal cord compression)
- Previous treatment with a PARP inhibitor, including olaparib
- Receipt of any radiotherapy for cancer treatment (except for palliative reasons)
within 30 days prior to first dose of study treatment or receipt of last dose of an
approved (marketed) anticancer therapy (chemotherapy, targeted therapy, biologic
therapy, monoclonal antibodies, etc) within 21 days prior to the first dose of study
treatment
- Concomitant use of known strong or moderate CYP3A inhibitors or concomitant use of
known strong or moderate CYP3A inducers
- Whole blood transfusions in the last 120 days prior to screening (packed red blood
cells and platelet transfusions are acceptable)