Pazopanib Pediatric Phase II Trial Children's Oncology Group in Solid Tumors

Phase 1

• Conditions: Rhabdomyosarcoma, non-rhabdomyosarcomatous soft tissue sarcoma (including synovial sarcoma, alveolar soft part sarcoma and desmoplastic small round cell tumor), Ewing sarcoma/peripheral Primitive Neuro Ectodermal Tumor (PNET), hepatoblastoma, neuroblastoma (measurable and evaluable), and osteosarcoma; MedDRA version: 20.0 Level: HLT Classification code 10019825 Term: Hepatoblastomas System Organ Class: 100000005101; MedDRA version: 20.0 Level: PT Classification code 10029260 Term: Neuroblastoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 15.1 Level: HLGT Classification code 10041299 Term: Soft tissue sarcomas System Organ Class: 100000004864; MedDRA version: 20.0 Level: PT Classification code 10031291 Term: Osteosarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0 Level: HLT Classification code 10039023 Term: Rhabdomyosarcomas System Organ Class: 100000143528; MedDRA version: 20.0 Level: PT Classification code 10015560 Term: Ewing's sarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-003595-12-SK
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-24
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 154

Inclusion Criteria

•Age: Patients must be at least 1 year and less than or equal to 18 years of age at the time of study entry.
•Diagnosis: Patients must have had histologic verification of one of the malignancies listed below at original diagnosis or at relapse.
1.Rhabdomyosarcoma
2.Non-rhabdomyosarcomatous Soft Tissue Sarcoma (including desmoplastic small round cell tumor)
3.Ewing Sarcoma/Peripheral PNET
4.Osteosarcoma
5.Neuroblastoma (Measurable)
6.Neuroblastoma (Evaluable)
7.Hepatoblastoma
•Patient must have disease that has either relapsed or is refractory to prior therapy

Are the trial subjects under 18? yes
Number of subjects for this age range: 154
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Pregnant or breast-feeding women are not eligible for this study
•Concomitant Medications
1.Corticosteroids: Patients requiring corticosteroid who have not been on a stable or decreasing dose of corticosteroid for the 7 days prior to enrollment are not eligible.
2.Investigational Drugs: Patients who are currently receiving another investigational drug are not eligible.
3.Anti-Cancer Agents or Radiation Therapy: Patients who are currently receiving other anti-cancer agents or radiation therapy are not eligible.
4.Anti-hypertensive: Patients who are currently receiving more than one anti-hypertensive medication (Grade 3) or whose blood pressure is not controlled (i.e. as defined in Section 3.2.8.) are not eligible for study enrollment.
5.Anti-coagulation: Patients must not be on therapeutic anticoagulation. ((Warfarin (coumadin®) and/or low molecular weight heparin are prohibited.) Prophylactic anticoagulation (ie intraluminal heparin) of venous or arterial access devices is allowed.
6.CYP3A4 Substrates and drugs causing QTc prolongation: Patients receiving drugs with a known risk of torsades de pointes are not eligible. See Appendices IIIA and IIIB and Section 4.8 for a list of enzyme inducing, enzyme inhibiting and other adversely interacting drugs and the appropriate washout periods required prior to study enrollment
Note: This list includes the prohibition of grapefruit juice for 14 days prior to enrollment and while receiving pazopanib.
7.Thyroid Replacement Therapy: Patients who require thyroid replacement therapy are not eligible if they have not been receiving a stable replacement dose for at least 4 weeks prior to study enrollment
•Patients who are unable to swallow tablets or liquid are not eligible. Pazopanib cannot be administered via NG tube or G-tube

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified