EUCTR2021-003444-25-PL进行中（未招募）1 期
PHASE 1/2 STUDY TO EVALUATE PALBOCICLIB (IBRANCE® ) INCOMBINATION 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 clinical trial of medicinal product
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.
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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 thesemedications 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,
- •History of or active congestive heart failure; if patient had congestive
- 另有 8 项未显示
研究者
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