NCT06485908Toborzás még nem indult1/2. fázis
Axitinib and Oral Metronomic Etoposide for Pediatric Children and AYA Refractory/Relapsing Medulloblastoma and Ependymoma
MEPENDAX: Phase I/II Study of Axitinib (Inlyta®) and Oral Metronomic Etoposide for Pediatric Children and AYA Refractory/Relapsing Medulloblastoma and Ependymoma
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2024. júl. 3. · Több mint 12 hónapja nem frissült - kérdezd meg a helyszínt, nyitott-e még
Rövid összefoglaló (regiszter, angolul)
It is an open multicentric phase I/II trial with axitinib (Inlyta®) and metronomic delivery of etoposide for children, adolescent and young adults (AYA) with refractory/ relapsing solid tumors. It is a two-stage trial: First stage: To determine the Maximum Tolerated Dose (MTD) of the combination of axitinib and oral metronomic etoposide for patient with medulloblastoma or ependymoma Second stage: Extension cohort evaluating the preliminary efficacy at the recommended dose for the phase II (RDP2) of the combination. The 2nd stage will start after a meeting of independent data monitoring committee (IDMC). Two cohorts of 9 patients with ependymoma and medulloblastoma Patients treated at first stage won't be included in the second stage.
- Állapot (regiszter)
- Toborzás még nem indult
- Fázis (regiszter)
- 1/2. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 40 (tervezett)
- Első benyújtás
- 2024. jún. 25.
- Kezdés
- 2024. okt.
- Elsődleges befejezés
- 2026. ápr.
- Fő szponzor
- Assistance Publique Hopitaux De Marseille
- Betegségek
- Gyermekkori daganatok
- NCT-szám
- NCT06485908
- EU CT-szám
- 2023-509585-38-00
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 1/2. fázis
- Tervezett résztvevők: 40
- 2024. okt. és az elsődleges befejezés (2026. ápr.) között
- 7 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
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Kiket keres a vizsgálat
- Histologically proven diagnosis of ependymoma or medulloblastoma
- Methyloma classification performed or available material for methyloma analysis
- Confirmed progressive or refractory disease despite standard therapy, or for which no effective standard therapy exists
- Male and female subjects with > 4 to ≤ 25 years of age at inclusion
- Weight > 20 kg
- Evaluable target lesion(s) according to RAPNO
- Performance status: Karnofsky performance status (for patients >12 years of age) or Lansky Play score (for patients ≤12 years of age) ≥ 70%. Patients who are unable to walk because of paralysis or stable neurological disability, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
- Life expectancy ≥ 3 months
- No known allergy to any of the compounds in the experimental treatment
- Able to take oral treatments
- Adequate organ function:
- Hematologic criteria
- Peripheral absolute neutrophil count (ANC) ≥ 1000/mm3 (unsupported)
- Platelet count ≥ 100,000/mm3 (unsupported)
- Hemoglobin ≥ 8.0 g/dL (transfusion is allowed) Cardiac function
- Shortening fraction (SF) >29% and left ventricular ejection fraction (LVEF) ≥50% at baseline, as determined by echocardiography (mandatory only for patients who have received cardiotoxic therapy).
- Renal and hepatic function
- Serum creatinine < 1.5 x upper limit of normal (ULN) for age
- Total bilirubin < 1.5 x ULN
- Alanine aminotransferase (ALT)/ Aspartate aminotransferase (AST)/ < 2.5 x ULN
- Able to comply with scheduled follow-up and with management of toxicity.
- Females of child bearing potential must have a negative serum pregnancy test within 7 days prior to initiation of treatment.
- Sexually active patients must agree to use adequate and appropriate contraception (in accordance with Clinical Trials Facilitation and Coordination Group (CTFG) recommendations) while on study drug and for 6 months after stopping the study drug.
- Patient able to comfortably swallow capsules.
- Written informed consent from parents/legal representative, patient, and age-appropriate assent before any study-specific screening procedures are conducted according to local, regional or national guidelines.
- Patient affiliated to a social security regimen or beneficiary of the same according to local requirements.
- Non-inclusion Criteria
- Chemotherapy within 21 days of day 1 from the start of study treatment. This period can be shortened in the case of treatment with vincristine (2 weeks) and extended to 6 weeks in the case of treatment with nitrosureas. The period is set to 5 half-lives in the case of targeted therapies or metronomic chemotherapy. The period is set to 2 weeks after bevacizumab administration. Evidence of > Grade 1 recent CNS hemorrhage on the baseline MRI or scan.
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter drug absorption of oral drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, or malabsorption syndrome).
- Clinically significant, uncontrolled heart disease (including history of any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality within 12 months of screening).
- Known active viral hepatitis or known human immunodeficiency virus (HIV) infection or any other uncontrolled infection.
- Presence of any NCI-CTCAE v5 grade ≥ 2 treatment-related extra-hematological toxicity with the exception of alopecia, ototoxicity or peripheral neuropathy.
- Known congenital immunodeficiency.
- Radiotherapy within the 2 months preceding D1 of the start of study treatment. Palliative RT on a non-target lesion is allowed up to 1 weeks before beginning of treatment.
- Major surgery within 21 days of the first dose. Gastrostomy, ventriculo-peritoneal shunt, endoscopic ventriculostomy, tumor biopsy and insertion of central venous access devices are not considered major surgery, but for these procedures, a 48 hour interval must be maintained before the first dose of the investigational drug is administered.
- Bleeding disorder.
- Clinically significant, uncontrolled heart disease (including history of any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality within 12 months of screening).
- Known hypersensitivity to any study drug or component of the formulation.
- Absence of effective contraception in patients of childbearing age (see appendix 3)
- Pregnant or nursing (lactating) females.
- Patients with galactose intolerance, lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).
- Severe infections requiring parenteral antibiotic therapy.
- Inability to undergo medical monitoring of the trial for geographic, social or psychological reasons.
Életkor a regiszterben: 4 év – 25 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (7)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Centre Hospitalier Universitaire D'Angers | Angers | Franciaország | Toboroz |
| Centre hospitalier Universitaire de Bordeaux | Bordeaux | Franciaország | Toboroz |
| Hospices Civils de Lyon | Lyon | Franciaország | Toboroz |
| Centre Hospitalier Regional De Marseille | Marseille | Franciaország | Toboroz |
| Institut Curie | Paris | Franciaország | Toboroz |
| Les Hopitaux Universitaires De Strasbourg | Strasbourg Cedex 2 | Franciaország | Toboroz |
| CHRU De Nancy | Vandoeuvre Les Nancy | Franciaország | Toboroz |
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