Study of Sunitinib in Young Patients With Refractory Solid Tumours

• Conditions: Paediatric solid tumours; MedDRA version: 14.1Level: LLTClassification code 10065252Term: Solid tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-000690-23-Outside-EU/EEA
• Lead Sponsor: ational Institution of Health (NCI)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-29
• Last Update Posted: 20 March 2012

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

- Patients must be = 2 years of age and = 21 years of age at the time of study entry
- Histologically confirmed solid tumor (not required for patients with intrinsic brain stem tumors or optic pathway gliomas). Patients with Recurrent or refractory disease are eligible including primary CNS tumors or known CNS metastases.
- Measurable or evaluable disease
- No known curative therapy or therapy proven to prolong survival with an acceptable quality of life.
- Karnofsky performance status (PS) 50-100% (> 10 years of age) OR Lansky PS 50-100% (= 10 years of age). Neurological deficits in pts with CNS tumor must have been relatively stable for = 1 week before study enrollment.
- Prior Therapy: Recovered from prior therapy
•At least 3 weeks since prior myelosuppressive therapy (6 weeks for nitrosoureas).
•At least 1 week since prior and no concurrent hematopoietic growth factors
•At least 1 week since prior antineoplastic biologic agents
•At least 2 weeks since prior local, palliative, small-port radiotherapy (at least 6 months for radiation to = 50% of pelvis). At least 6 weeks since other prior substantial bone marrow radiotherapy
•At least 3 months since prior stem cell transplantation or rescue (without total-body irradiation) and no evidence of graft-vs-host disease
- Organ function requirements:
•Absolute neutrophil count = 1,000/mm³
•Platelet count = 100,000/mm³ (transfusion independent)
•Hemoglobin = 8.0 g/dL (transfusions allowed)
•Creatinine clearance or radioisotope glomerular filtration rate = 70 mL/min OR creatinine based on age/gender as follows:
•No greater than 0.8 mg/dL (2 to 5 years of age)
•No greater than 1 mg/dL (6 to 9 years of age)
•No greater than 1.2 mg/dL (10 to 12 years of age)
•No greater than 1.5 mg/dL (male) OR 1.4 mg/dL (female) (13 to 15 years of age)
•No greater than 1.7 mg/dL (male) OR 1.4 mg/dL (female) (= 16 years of age)
•Bilirubin = 1.5 times upper limit of normal (ULN)
•ALT = 2.5 times ULN
•Albumin = 2 g/dL
•LVEF or shortening fraction normal
•Corrected QT interval = 450 msec
•Amylase = 1.5 times ULN
•Lipase = 1.5 times ULN
•Blood pressure within ULN

Are the trial subjects under 18? yes
Number of subjects for this age range: 50
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Prior Therapy:
•No prior anthracycline (any dose)
•No prior radiotherapy to a radiation field that included the heart (including total body or craniospinal irradiation)
•No prior sunitinib malate
- Not Pregnant or nursing women. Fertile patients must use effective contraception
- Concomitant Medications:
•No other concurrent investigational drugs
•No other concurrent anticancer agents, including chemotherapy, radiotherapy, immunotherapy, or biologic therapy
•At least 12 days since prior and no concurrent CYP3A4 inducers, including any of the following: Rifampin, Rifabutin, Carbamazepine, Phenobarbital, Phenytoin, Hypericum perforatum (St. John's wort); Efavirenz; Tipranavir.
•No concurrent antithrombotic or antiplatelet agents, including any of the following: Warfarin, Heparin, Low molecular weight heparin, Acetylsalicylic acid (aspirin), Ibuprofen, Other nonsteroidal anti-inflammatory drugs
•At least 7 days since prior and no concurrent CYP3A4 inhibitors, including any of the following: Azole antifungals (e.g., itraconazole or ketoconazole), Clarithromycin, Erythromycin, Diltiazem, Verapamil, HIV protease inhibitors (e.g., indinavir, saquinavir, ritonavir, atazanavir, or nelfinavir), Delavirdine.
- No uncontrolled infection
- No tumors involving the pleural surface
- No pts with body surface area < 0.5 m² (for parts A and B) and < 0.4 m² (for Part C)
- Able to swallow sunitinib malate capsules (parts A and B only)
- No pre-existing thyroid abnormality (hyper- or hypothyroidism) with unstable thyroid function
- No history of allergic reaction attributed to sunitinib malate or component of sunitinib malate capsules
- No patients with known bone marrow metastasis
- No patients with prior allergy to both applesauce and yoghurt (Part C only).
- In pts with primary CNS tumors or known CNS metastases:
•No evidence of new CNS hemorrhage on baseline MRI obtained within 14 days before study enrollment (ECHO gradient MRI sequences per institutional guidelines required for evaluation of CNS hemorrhage)
•The presence of small punctuate CNS hemorrhage on these scans will exclude a patient from participation

Study & Design

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