Oral MK8669 in Children/Adolescents with Solid Tumors (8-17 years)
- Conditions
- advanced solid tumors including lymphoma and tumors of the central nervous systemMedDRA version: 14.1 Level: LLT Classification code 10065143 Term: Malignant solid tumour System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-000729-55-FR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
•Male or female age 6 to 17 years (included) on day of signing informed consent.
•Histologic or cytologic diagnosis of a malignant solid tumor, including tumors of the central nervous system and lymphoma that have progressed despite standard therapy or for which no effective standard therapy is known. Patients who have received standard therapy and continue to have biopsy proven residual stable disease are eligible. In the absence of a biopsy, patients with sarcoma would be eligible on the basis of persistent PET activity or by MIBG in neuroblastoma.
•Patient must be able to swallow tablets.
•Performance Status: Lansky Play Scale =70 for children <10 years of age; Karnofsky score =70 for children =10 to <16 years; or ECOG Status 0-2 for patients age 16 and older.
•Patient has a Body Surface Area (BSA) that allows evaluation of the current dose level.
Are the trial subjects under 18? yes
Number of subjects for this age range: 30
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
•Patients currently receiving any other investigational agents or using any investigational devices.
•Patients with leukemia.
•Patients who have previously received ridaforolimus, rapamycin, or other rapamycin analogs.
•History of allergic reactions attributed to compounds of similar chemical or biologic composition to ridaforolimus.
•Patient has persistent acute toxicity from previous therapy = Grade 2 by NCI CTCAE Version 4 (excluding alopecia, neuropathy, or hearing loss).
•Uncontrolled intercurrent illness despite adequate therapy.
•Pregnancy or females who are breastfeeding.
•Patient has a requirement for concurrent treatment with medications that are inducers or inhibitors of cytochrome P450 (CYP3A). Patients should be off these medications for at least 2 weeks prior to the first dose of ridaforolimus.
•Patient has poorly controlled Type 1 or 2 diabetes, defined as a fasting glucose >160 mg/dL.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method