A Phase 2 trial studying how lenvatinib works in combination with Ifosfamide and Etoposide compared to Ifosfamide and Etoposide in treating Children, Adolescents and Young Adults for a type of cancer that is not responding to treatment or has reappeared following an initial recovery.
- Conditions
- Relapsed or Refractory OsteosarcomaMedDRA version: 21.1Level: LLTClassification code 10065147Term: Malignant solid tumorSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2019-003696-19-IT
- Lead Sponsor
- EISAI LIMITED
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 81
Please see protocol section 8.3 of the Protocol for the full list of the inclusion criteria:
1. Histologically or cytologically confirmed diagnosis of high grade osteosarcoma.
2. Refractory or relapsed osteosarcoma after 1 to 2 prior systemic treatments.
3. Measurable or evaluable disease per RECIST 1.1 that meets the following criteria:
- Must be accurately measurable with a minimum size (by long axis) of 10 mm using computed tomography/magnetic resonance imaging (CT/MRI) (lymph nodes must be accurately measurable with a minimum size [by short axis] of 15 mm).
- Lesions that have had external beam radiotherapy (EBRT) or locoregional therapies such as radiofrequency (RF) ablation must have subsequently grown unequivocally to be deemed a target lesion.
4. Aged 2 years to =25 years at the time of informed consent.
5. Life expectancy of 12 weeks or more.
6. Lansky play score =50% or Karnofsky Performance Status score =50%. Use Karnofsky for subjects =16 years of age and Lansky for subjects <16 years of age. Subjects who are unable to walk because of paralysis, but who are up in wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
7. Adequate bone marrow function as evidenced by:
a. absolute neutrophil count (ANC) =1.0×10^9/L. (subjects with bone marrow involvement should have ANC =0.8×10^9/L and leucocyte count =1×10^9/L).
b. hemoglobin =8.0 g/dL (a hemoglobin of <8.0 g/dL is acceptable if it is corrected by growth factor or transfusion before Cycle 1 Day 1).
c. platelet count =75×109/L.
8. Adequate blood coagulation function defined by International Normalized ratio (INR) =1.5 unless participant is receiving anticoagulant therapy, as long as INR is within therapeutic range of intended use of anticoagulants.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 31
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Please see protocol section 8.3 of the Protocol for the full list of the inclusion criteria:
1. Any active infection or infectious illness unless fully recovered prior to Cycle 1 Day 1.
2. Subjects with central nervous system metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication at least 2 weeks before C1D1
3. Active second malignancy within 2 years prior to enrollment
4. Any medical or other condition that in the opinion of the investigator(s) would preclude the subject's participation in a clinical study.
5. Has had major surgery within 3 weeks prior to Cycle 1 Day 1.
6. Known hypersensitivity to any component(s) of the study drugs (lenvatinib, ifosfamide, and etoposide, or their ingredients).
7. Currently receiving any investigational drug or device in another clinical study or within 28 days prior to Cycle 1 Day 1.
8. A clinically significant ECG abnormality, including a marked baseline prolonged QT or QTc interval (eg, a repeated demonstration of a QTc interval >480 msec).
9. Gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that in the opinion of the investigator might affect the absorption of lenvatinib.
10. Pre-existing Grade =3 gastrointestinal or non-gastrointestinal fistula.
11. Gastrointestinal bleeding or active hemoptysis (bright red blood of at least ½ teaspoon) within 3 weeks prior to Cycle 1 Day 1.
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