EUCTR2021-003444-25-CZ进行中（未招募）1 期
PHASE 1/2 STUDY TO EVALUATE PALBOCICLIB (IBRANCE® ) IN COMBINATION WITH IRINOTECAN AND TEMOZOLOMIDE OR IN COMBINATION WITH TOPOTECAN AND CYCLOPHOSPHAMIDE INPEDIATRIC PATIENTS WITH RECURRENT OR REFRACTORY SOLID TUMORS
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Pfizer Inc.
- 入组人数
- 75
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
- 性别
- All
入选标准
- •Patients must meet all the following inclusion criteria to be eligible for
- •enrollment in the study:
- •1. Histologically confirmed relapsed or refractory solid tumor as follows:
- •For dose escalation and dose determination parts: Histologically
- •confirmed relapsed or refractory solid tumor (including CNS tumors but
- •not lymphomas). Patients with Diffuse Intrinsic Pontine Glioma do not
- •require histological only radiographic confirmed relapse to enroll.
- •For dose expansion cohorts: Histologically confirmed relapsed or
- •refractory solid tumor including but not limited to EWS, rhabdoid tumor,
- •rhabdomyosarcoma, neuroblastoma, and medulloblastoma. Patients with
- •Diffuse Intrinsic Pontine Glioma do not require histological only
- •radiographic confirmed relapse to enroll.
- •For tumor-specific cohorts: Histologically confirmed relapsed or
- •refractory solid tumor including but not limited to EWS, rhabdoid tumor,
- •rhabdomyosarcoma, neuroblastoma, and medulloblastoma. Patients with
- •Diffuse Intrinsic Pontine Glioma do not require histological only
- •radiographic confirmed relapse to enroll.
- •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 as
- •shown in Table 10:
- •Table 10. Maximum Allowed Creatinine Levels
- •Age Maximum Serum Creatinine (mg/dL)
- •Male Female
- •2 to <6 years 0.8 0.8
- •6 to <10 years 1.0 1.0
- •10 to <13 years 1.2 1.2
- •13 to <16 years 1.5 1.4
- •16 to <21 years 1.7 1.4
- •The threshold creatinine values in this table were derived from the
- •Schwartz formula for estimating glomerular filtration rate utilizing child
- •length and stature data published by the CDC.
- 另有 12 项未显示
排除标准
- •Patients with any of the following characteristics/conditions will not be
- •included in the study:
- •1. Phase 1 portion and tumor specific cohorts: For palbociclib with IRN
- •and TMZ combination, prior treatment with a CDK4/6 inhibitor or
- •progression while on treatment with an IRN-containing regimen that
- •includes TMZ. Patients who have
- •received the combination of IRN and TMZ and did not progress while on
- •these medications are eligible. For patients enrolling in the palbociclib
- •with TOPO and CTX combination, prior treatment with a CDK4/6 inhibitor
- •or progression while on treatment with a TOPO-containing regimen that
- •includes CTX. Patients who have received the combination of TOPO and
- •CTX and did not progress while on these medications are eligible. Phase 2
- •portion: prior treatment with a CDK4/6 inhibitor or progression while on
- •treatment with an IRN-containing or TMZ-containing 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
- •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 >14 days.
- •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 post surgery and are neurologically stable.
- •11. Hereditary bone marrow failure disorder.
- •12. QTc >470 msec.
- •13. History of clinically significant or uncontrolled cardiac disease, including:
- •History of or active congestive heart failure; if patient had congestive heart failure resolve and >1 year from resolution, patient will be considered eligible;
- •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 eff
研究者
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