Combination chemotherapy with pazopanib and ICE in children and adolescents with relapsed/refractory solid tumors

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0003260

Enrollment

Registered

2018-10-12

Start date

2019-08-20

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Pazopanib + ICE combination chemotherapy * ICE (Ifosfamide, carboplatin, etoposide) Ifosfamide 900 mg/m2/day, d0–4 Carboplatin 300 mg/m2/day, d0, 1 Etoposide 75 mg/m2/day, d0–4 * Pazopanib Co

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
MTD of Pazopanib in combination chemotherapy;Response rate	—

Secondary

Measure	Time frame
Progression free survival	—

Countries

Korea, Republic of

Contacts

Public ContactSo Yeon Lee

Samsung Medical Center

sy41999@naver.com+82-2-3410-2150

Outcome results