A Study to Compare the Efficacy and Safety of Ifosfamide and Etoposide With or Without Lenvatinib in Children Adolescents and Young Adults With Relapsed and Refractory Osteosarcoma

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    72
  • sponsor
    Eisai Inc.
Updated on 30 November 2021
cancer
nitrosoureas
etoposide
cancer chemotherapy
ifosfamide
ototoxicity
recurrent osteosarcoma
refractory osteosarcoma

Summary

This Is a Multicenter, Randomized, Open-Label, Parallel-Group, Phase 2 Study to Compare the Efficacy and Safety of Lenvatinib in Combination with Ifosfamide and Etoposide Versus Ifosfamide and Etoposide in Children, Adolescents, and Young Adults with Relapsed or Refractory Osteosarcoma.

Details
Condition Osteosarcoma, Sarcoma, Sarcoma (Pediatric), Soft Tissue Sarcoma, bone sarcoma
Treatment etoposide, ifosfamide, Lenvatinib
Clinical Study IdentifierNCT04154189
SponsorEisai Inc.
Last Modified on30 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologically or cytologically confirmed diagnosis of high grade osteosarcoma
Refractory or relapsed osteosarcoma after 1 to 2 prior lines of systemic treatments
Measurable or evaluable disease per RECIST 1.1
Life expectancy of 12 weeks or more
Lansky play score greater than or equal to (>=) 50 Percent (%) or Karnofsky Performance Status score >=50%. Use Karnofsky for participants >=16 years of age and Lansky for participants less than (<)16 years of age. Participants who are unable to walk because of paralysis, but who are able to perform activities of daily living while wheelchair bound, will be considered ambulatory for the purpose of assessing the performance score
Adequate organ function per blood work
Adequate cardiac function as evidenced by left ventricular ejection fraction (LVEF) >=50% at baseline as determined by echocardiography or multigated acquisition (MUGA) scan
Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as
BP <95th percentile for sex, age, and height/length at screening (as per
National Heart Lung and Blood Institute guidelines) and no change in
antihypertensive medications within 1 week prior to Cycle 1 Day 1
Participants >18 years of age should have BP less than or equal to (<=) 150/90
millimeters of Mercury at screening and no change in antihypertensive therapy
within 1 week prior to Cycle 1 Day 1
\. Washout before Cycle 1 Day 1 of 3 weeks in case of prior chemotherapy, 6
weeks if treatment included nitrosoureas; 4 weeks for definitive radiotherapy
weeks for palliative radiotherapy; and 3 months from high-dose chemotherapy
and stem cell rescue. For all other anti-cancer therapies, washout before
Cycle 1 Day 1 of at least 5 half-lives (or at least 28 days, whichever is
shorter). Participants must have recovered [to Grade <=1, except for alopecia
ototoxicity, and Grade <=2 peripheral neuropathy, per common terminology
criteria for adverse events (CTCAE) v5.0] from the acute toxic effects of all
prior anticancer therapy before Cycle 1 Day 1
\. Must have no prior history of lenvatinib treatment
Eligibility for optional lenvatinib crossover
Disease progression per RECIST 1.1 (as confirmed by IIR for all participants who crossover prior to the study data-cut)
No new systemic anti-cancer medication administered after the last dose of study drugs

Exclusion Criteria

Any active infection or infectious illness unless fully recovered prior to Cycle 1 Day 1 (that is, no longer requiring systemic treatment)
Participants with central nervous system metastases are not eligible, unless they have completed local therapy (example, whole brain radiation therapy, surgery or radiosurgery) and have discontinued the use of corticosteroids for this indication for at least 2 weeks before Cycle 1 Day 1
Active second malignancy within 2 years prior to enrollment ([in addition to osteosarcoma], but not including definitively treated superficial melanoma, carcinoma-in-situ, basal or squamous cell carcinoma of the skin)
Has had major surgery within 3 weeks prior to Cycle 1 Day 1. Note: Adequate wound healing after major surgery must be assessed clinically, independent of time elapsed for eligibility
Gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that in the opinion of the investigator might affect the absorption of lenvatinib
Pre-existing Grade >=3 gastrointestinal or non-gastrointestinal fistula
Study is ongoing
Gastrointestinal bleeding or active hemoptysis (bright red blood of at least 1 divided [/] by 2 teaspoon) within 3 weeks prior to Cycle 1 Day 1
Exclusion Criteria
Radiographic evidence of intratumoral cavitation, encasement, or invasion of a major blood vessel. Additionally, the degree of proximity to major blood vessels should be considered for exclusion because of the potential risk of severe hemorrhage associated with tumor shrinkage/necrosis after lenvatinib therapy
History of ifosfamide-related Grade >=3 nephrotoxicity or encephalopathy
Known to be human immunodeficiency virus (HIV) positive
A clinically significant electrocardiogram (ECG) abnormality, including a marked baseline prolonged QT or corrected QT (QTc) interval (example, a repeated demonstration of a QTc interval greater than [>] 480 millisecond [msec])
Has clinically significant cardiovascular disease within 6 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability. Note: Medically controlled arrhythmia would be permitted
Known active Hepatitis B (example, Hepatitis B surface antigen [HBsAg] reactive) or Hepatitis C (example, hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected). Note: Testing for Hepatitis B or Hepatitis C is required at screening only when mandated by local health authority
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