Study Of Palbociclib Combined With Chemotherapy In Pediatric Patients With Recurrent/Refractory S… (NCT03709680) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Study Of Palbociclib Combined With Chemotherapy In Pediatric Patients With Recurrent/Refractory Solid Tumors
United States128 participantsStarted 2019-05-24
Plain-language summary
A study to learn about safety and find out maximum tolerable dose of palbociclib given in combination with chemotherapy (temozolomide with irinotecan or topotecan with cyclophosphamide) in children, adolescents and young adults with recurrent or refractory solid tumors (phase 1). Neuroblastoma tumor specific cohort to further evaluate antitumor activity of palbociclib in combination with topotecan and cyclophosphamide in children, adolescents, and young adults with recurrent or refractory neuroblastoma. Phase 2 to learn about the efficacy of palbociclib in combination with irinotecan and temozolomide when compared with irinotecan and temozolomide alone in the treatment of children, adolescents, and young adults with recurrent or refractory Ewing sarcoma (EWS).
Who can participate
Age range2 Years – 20 Years
SexALL
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Inclusion criteria
✓. Histologically confirmed relapsed or refractory solid tumor as follows:
✓. Age ≥2 and \<21 years at the time of study entry.
✓. 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.
✓. Adequate bone marrow function.
✓. Adequate renal function: Serum creatinine level based on age/gender must within protocol specified limits.
✓. Adequate liver function, including:
✓. 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.
✓. 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.
Exclusion criteria
What they're measuring
1
Phase 2 open-label, randomized: Event-free survival (EFS) based on Investigator assessment.
Timeframe: Baseline to Month 24.
2
Phase 1: First Cycle Dose-Limiting Toxicities (DLT)
Timeframe: First cycle (cycle length is approximately 21 days)
3
Phase 1: Dose Expansion Parts: Frequency of adverse events
Timeframe: At least 28 days after last dose
4
Phase 1: Dose Expansion Parts: Percentage of Participants With Complete Response or Partial Response
Timeframe: Through the end of treatment (up to at least 28 days after last dose)
✕. Phase 1 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.
✕. Prior intolerability to IRN and/or TMZ plus/minus palbociclib with IRN and TMZ combination 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.
✕. 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 Cycle 1 Day 1 (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 (See Section 5.7.1 for list of products.)
✕. Systemic anti cancer therapy within 2 weeks prior to study entry and 6 weeks for nitrosoureas.
✕. Prior irradiation to \>50% of the bone marrow (see Appendix 9).
✕. Participation in other studies involving investigational drug(s) within 2 weeks or 5 half lives, whichever is longer, prior to study entry.
✕. Major surgery within 4 weeks prior to study entry. Surgical biopsies or central line placement are not considered major surgeries.
✕. 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.