Clinical trial · Interventional
Combination Chemotherapy With Pazopanib in Children and Adolescents With Relapsed/Refractory Solid Tumors
Safety and Efficacy of Combination Chemotherapy With Pazopanib in Children and Adolescents With Relapsed/Refractory Solid Tumors
NCT03628131CI-TRIAL-00034951unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the safety and efficacy of combination chemotherapy with Pazopanib in pediatric patients with relapsed/refractory solid tumor
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Refractory Pediatric Solid Tumor | Childhood Solid Neoplasm | CURATED_BROADER | 0.80 |
| Relapsed Pediatric Solid Tumor | Childhood Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| Ifosfamide | Drug | Ifosfamide | ALIAS |
| Pazopanib | Drug | Pazopanib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pazopanib + conventional chemotherapy
- description
- Conventional chemotherapy (Ifosfamide, carboplatin, etoposide) with Pazopanib
- interventionNames
- Drug: Pazopanib
- Drug: Ifosfamide
- Drug: Carboplatin
- Drug: Etoposide
Primary outcomes (1)
- measure
- Maximum Tolerated Dose (MTD) of Pazopanib in combination chemotherapy
- timeFrame
- 42 days
- description
- Definition of dose-limiting toxicity (DLT) * Hematologic DLT: delayed recovery of ANC/platelets \> 42 days * Grade 3 creatinine elevation, proteinuria, hyperbilirubinemia, bleeding * Grade 2 arterial thrombosis * Any grade 4 toxicities except hematologic toxicities
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 22 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with refractory/relapsed solid tumor (Stable or progressive disease after 1st-line treatment or relapse) * Patients previously enrolled to "Genomic diagnosis of pediatric tumors by NGS (IRB No. SMC 2015-11-053)" Exclusion Criteria: * Patients who had high-dose chemotherapy and autologous stem cell transplantation previously * Patients with organ dysfunction as follows (creatinine elevation ≥ 1.5 x upper limit of normal (ULN), ejection fraction \<40%, significant arrhythmia or conduction disturbance) * Patients who are not eligible to have scheduled treatment due to the other significant impaired organ function * Patients with active bleeding * Patients who are taking strong CYP3A4 inhibitors, QTc-prolonging drugs, antithrombotic agents, or anti-platelet agents * Pregnant or nursing women * Patients who can not swallow the pill
References
Publications (0)
Data not yet available
No reference posted for this study.