Study Of Palbociclib Combined With Chemotherapy In Pediatric Patients With Recurrent/Refractory Solid Tumors

No strong warning signs right now. The score counts warning signs; it is not a prediction.

Why this score

Score over time

What counts as success

The trial's main goal(s), called the “primary outcome.”

• Phase 1, Dose Escalation/Dose Determination Cohorts: Number of Participants With Dose Limiting Toxicities (DLTs)

  Measured over: Cycle 1 (21 days)

• Phase 1, Dose Expansion Cohorts and TSC: Number of Participants With Treatment-emergent AEs, Treatment-emergent Serious AEs (SAEs), Treatment Related AEs, Treatment Related SAEs and AEs of Maximum Grade 3 or 4 and 5

  Measured over: First dose of study treatment (Day 1) up to 35 days after last dose of study treatment (maximum up to approximately 25 months)

• Phase 1, Dose Expansion Cohorts and TSC: Number of Participants With Maximum CTCAE Grade in Hematology Parameters

  Measured over: First dose of study treatment (Day 1) up to 35 days after last dose of study treatment (maximum up to approximately 25 months)

• Phase 1, Dose Expansion Cohorts and TSC: Number of Participants With Maximum CTCAE Grade in Chemistry Parameters

  Measured over: First dose of study treatment (Day 1) up to 35 days after last dose of study treatment (maximum up to approximately 25 months)

• Phase 1, Dose Expansion Cohorts and TSC: Number of Participants With Post-Baseline and Maximum Change From Baseline in Electrocardiogram (ECG) Parameters

  Measured over: Baseline (pre-treatment) up to Cycle 3 (63 days)

• Phase 1, Dose Expansion Cohorts and TSC: Maximum Change From Baseline in Vital Signs Parameter- Blood Pressure

  Measured over: Baseline (pre-treatment) up to end of study treatment (maximum up to approximately 24.2 months)

• Phase 1, Dose Expansion Cohorts and TSC: Maximum Change From Baseline in Vital Signs Parameter- Pulse Rate

  Measured over: Baseline (pre-treatment) up to end of study treatment (maximum up to approximately 25 months)

• Phase 1, Dose Expansion Cohorts and TSC: Number of Participants With Clinically Significant Changes in Glycosylated Hemoglobin (HbA1c)

  Measured over: First dose of study treatment (Day 1) up to 35 days after last dose of study treatment (maximum up to approximately 25 months)

• Phase 1, Dose Expansion Cohorts: Objective Response (OR) Rate Based on Investigator Assessment

  Measured over: First dose of study treatment (Day 1) up to maximum of approximately 25 months

• TSC: OR Rate Based on Investigator Assessment

  Measured over: First dose of study treatment (Day 1) up to maximum of approximately 25 months

• Phase 2: Event Free Survival (EFS) Based on Investigator Assessment

  Measured over: From date of randomization up to objective PD, diagnosis of secondary malignancy or death, whichever occurred first (maximum of approximately 14 months)

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