PHASE 1/2 STUDY TO EVALUATE PALBOCICLIB (IBRANCE® ) IN COMBINATION WITH IRINOTECAN AND TEMOZOLOMIDE AND/OR IN COMBINATION WITH TOPOTECAN AND CYCLOPHOSPHAMIDE IN PEDIATRIC PATIENTS WITH RECURRENT OR REFRACTORY SOLID TUMORS - A5481092

Pfizer0 个研究点目标入组 2 人开始时间: 待定最近更新: 2024年4月9日

适应症

试验速览

阶段: 2 期
状态: 撤回
发起方: Pfizer
入组人数: 2

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 2 至 64（—）

入选标准

•1. Histologically confirmed relapsed or refractory solid tumor as follows:
•For randomized Phase 2 part: Histologically confirmed Ewing sarcoma at
•diagnosis or at relapse, with presence of EWSR1-ETS or FUS-ETS rearrangement.
•Histopathology confirmation of both EWSR1-ETS or FUSETS rearrangement partners
•is required OR availability of formalin fixed paraffin embedded (FFPE) tumor
•tissue sample for central testing. Patient must have relapsed or have
•refractory disease and at least evaluable disease in at least one site other
•than bone marrow that can be followed by imaging.
•2. Age >=2 and <21 years at the time of study entry. Refer to Section 4.3 for
•reproductive criteria for male and female participants.
•3. Lansky performance status >=50% for patients <=16 years of age, or Eastern
•Cooperative Oncology Group (ECOG) 0, 1 or 2 for patients >16 years of age.
•4. Adequate bone marrow function.
•Absolute neutrophil count >=1000/mm3;
•Platelet count >=75,000/mm3 (transfusion independent, no platelet transfusion
•in past 7 days prior study entry);
•Hemoglobin >=8.5 g/dL (transfusion allowed).
•5. Adequate renal function: Serum creatinine level based on age/gender must be
•less than or equal to the following maximum upper limits
•6. Adequate liver function, including:
•Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=2.5 ×
•upper limit of normal (ULN) or <=5 × ULN for age, if attributable to disease
•involvement of the liver;
•Total bilirubin <=1.5 × ULN for age unless the patient has documented
•Gilbert's syndrome. Patients with documented Gilbert's syndrome are eligible
•if direct bilirubin is within normal ranges (<=ULN).
•7. Patients enrolled to Phase 1 portion of the study and tumor specific
•cohorts must have measurable disease as defined by RECIST version 1.1 or
•modified RANO criteria for CNS disease or at least evaluable disease by INRC
•for neuroblastoma.
•The eligible patients with neuroblastoma must have at least one of the
•following at the time of study entry:
•Measurable tumor by CT or MRI that is avid on MIBG scan or demonstrates
•increased FDG uptake on PET scan;
•Avid lesion on MIBG scan with positive uptake at a minimum of one site;
•For disease that is not avid by MIBG-scan, at least one lesion that
•demonstrates increased FDG uptake on PET scan AND viable neuroblastoma
•confirmed by current or prior biopsy;
•bone marrow involvement with more than 5% neuroblastoma cells in at least one
•sample from bilateral bone marrow biopsies;
•In non MIBG-avid refractory soft tissue disease that does not demonstrate
•increased FDG uptake; lesion biopsy is required to document the presence of
•viable neuroblastoma, unless patient has a
•new soft tissue lesion (radiographic evidence of disease progression). Patients
•with EWS enrolled to Phase 2 portion of the study are eligible with at least
•evaluable disease (eg, bone only disease with no soft tissue component).
•8. Recovered to CTCAE Grade <=1, or to baseline, from any non-hematological
•acute toxicities of prior surgery, chemotherapy,
•immunotherapy, radiotherapy, differentiation therapy or biologic
•therapy, with the exception of alopecia.
另有 2 项未显示

排除标准

•1. Phase 2 portion: prior treatment with a CDK4/6 inhibitor or progression
•while on treatment with an IRN-containing or TMZcontaining regimen. Patients
•who have received IRN and/or TMZ and did
•not progress while on these medications are eligible.
•2. Prior intolerability to IRN and/or TMZ for IRN and TMZ plus/minus
•palbociclib combinations and prior intolerability to TOPO and/or CTX for TOPO
•and CTX combination. For patients enrolled in the UK, any contraindication for
•IRN and/or TMZ treatment, as per the local SmPC.
•3. Use of strong cytochrome P450 (CYP) 3A inhibitors or inducers within 12 days
•of study entry. Patients who are receiving strong uridine
•diphosphate-glucuronosyl transferase 1A1 (UGT1A1) inhibitors within 12 days of
•C1D1 are not eligible for the palbociclib with IRN and TMZ combination.
•Patients who are receiving strong UGT1A1 inhibitors within 12 days of C1D1 are
•eligible for the palbociclib with TOPO and CTX combination
•4. Systemic anticancer therapy within 2 weeks prior to study entry and 6 weeks
•for nitrosoureas.
•5. Prior irradiation to >50% of the bone marrow (see ATTACHMENTS).
•6. Participation in other studies involving investigational drug(s) within 2
•weeks or 5 halflives, whichever is longer, prior to study entry.
•7. Major surgery within 4 weeks prior to study entry. Surgical biopsies or
•central line placement are not considered major surgeries.
•8. For IRN and TMZ with/without palbociclib combinations: known or suspected
•hypersensitivity to palbociclib, dacarbazine, IRN and/or TMZ. For combination
•of palbociclib with TOPO and CTX: known or suspected hypersensitivity to
•palbociclib, TOPO and/or CTX
•9. Patients with known symptomatic brain tumors or brain metastases and require
•steroids, unless they have been on a stable or on a decreasing steroid dose for
•10. Patients with previously diagnosed brain metastases are eligible if they
•have completed their prior treatment and have recovered from the acute effects
•of radiation therapy or surgery prior to study entry for these metastases for
•at least 14 days postradiation and 4 weeks postsurgery
•and are neurologically stable.
•11. Hereditary bone marrow failure disorder.
•12. QTc >470 msec.
•13. History of clinically significant or uncontrolled cardiac disease,
•History of or active congestive heart failure; if patient had congestive
•heart failure resolve and >1 year from resolution, patient will be considered
•Clinically significant ventricular arrhythmia (such as ventricular
•tachycardia, ventricular fibrillation or Torsades de Pointes);
•Diagnosed or suspected congenital or acquired prolonged QT syndrome;
•Need for medications known to prolong the QT interval;
•Uncorrected hypomagnesemia or hypokalemia because of potential effects on the
•QT interval;
•Left ventricular ejection fraction <50% or shortening fraction <28%.
•14. Recent or ongoing clinically significant gastrointestinal disorder that may
•interfere with absorption of orally administered drugs (eg, gastrectomy).
•15. Evidence of serious active or uncontrolled bacterial, fungal or viral
•infection or known history of hepatitis B virus, hepatitis C virus, or human
•immunodeficiency virus infection or acquired immunodeficiency syndrome-related
•illness. Screening for viral hepatitis and HIV is under <

研究者

发起方

Pfizer

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