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A Phase 1/2 Study of Lenvatinib in Combination With Everolimus in Recurrent and Refractory Pediatric Solid Tumors Including CNS Tumors
Study on Investigational Medication Combination for Pediatric Tumors
Recruiting
2 years - 21 years
All
Phase
N/A
1 Location
Brief description of study.
In this study, you will receive the combination of lenvatinib with everolimus. The main purpose of this study is: To study the effects of this combination of study drugs on your body To determine the highest safe dose of study drugs that can be given in combination To determine what happens to the study drugs in your body (how your body absorbs, distributes, breaks down and excretes these drugs)
To assess biomarkers (markers that may help researchers understand the disease and effectiveness of lenvatinib and everolimus) in blood and tumor tissues To assess any shrinkage in your tumor.
To assess biomarkers (markers that may help researchers understand the disease and effectiveness of lenvatinib and everolimus) in blood and tumor tissues To assess any shrinkage in your tumor.
Detailed description of study
The purpose of this study is to determine a maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of lenvatinib administered in combination with everolimus, once daily to pediatric subjects with recurrent/refractory solid tumors; and to describe the toxicities of lenvatinib administered in combination with everolimus once daily to pediatric subjects with recurrent/refractory solid tumors.
Participants will be paid for their participation.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Cancer,Solid Tumor
-
Age: 2 years - 21 years
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Gender: All
Inclusion Criteria
Histologically or cytologically confirmed diagnosis of the following tumor types:
a. Phase 1: Recurrent or refractory solid tumors (excluding hepatoblastoma and lymphomas), including primary central nervous system (CNS) tumors; subjects must have either measurable or evaluable disease.
b. Phase 2 : Recurrent of refractory tumors; subjects must have measurable disease
Cohort 1: Ewing sarcoma/pPNET
Cohort 2: Rhabdomyosarcoma
Cohort 3: HGG (subjects with Diffuse Intrinsic Pontine Glioma are not eligible)
Subjects must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment. If after the required timeframe, the numerical eligibility criteria are met, eg, blood
count criteria, the subject is considered to have recovered adequately
Adequate renal function
Adequate liver function
Adequate cardiac function
Adequate neurologic function
Adequate BP control with or without antihypertensive medications
Adequate coagulation
Adequate pancreatic function
Adequate metabolic function
Exclusion Criteria
Subjects who have had or are planning to have invasive procedures
Subjects who have non-healing wound, unhealed or incompletely healed fracture, or a compound (open) bone fracture at the time of enrollment
Clinical evidence of nephrotic syndrome prior to enrollment
Gastrointestinal bleeding or active hemoptysis (bright red blood of at least half teaspoon) within 21 days prior to enrollment
Thrombotic/ thromboembolic event requiring systemic anticoagulation within 90 days prior to enrollment
Evidence of new intracranial hemorrhage of more than punctate size on MRI assessment obtained within 28 days prior to study enrollment for subjects with HGG
Diagnosis of lymphoma
Radiographic evidence of major blood vessel invasion/infiltration.
Evidence of untreated CNS metastases
Subjects who are currently receiving enzyme-inducing anticonvulsants
Subjects chronically receiving strong cytochrome P450 3A4 (CYP3A4)/P-glycoprotein (P-gp) inhibitors or inducers within 7 days prior to study enrollment (See Appendix 15 for a list of strong inhibitors and inducers)
Females who are breastfeeding or pregnant at Screening or Baseline
Histologically or cytologically confirmed diagnosis of the following tumor types:
a. Phase 1: Recurrent or refractory solid tumors (excluding hepatoblastoma and lymphomas), including primary central nervous system (CNS) tumors; subjects must have either measurable or evaluable disease.
b. Phase 2 : Recurrent of refractory tumors; subjects must have measurable disease
Cohort 1: Ewing sarcoma/pPNET
Cohort 2: Rhabdomyosarcoma
Cohort 3: HGG (subjects with Diffuse Intrinsic Pontine Glioma are not eligible)
Subjects must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment. If after the required timeframe, the numerical eligibility criteria are met, eg, blood
count criteria, the subject is considered to have recovered adequately
Adequate renal function
Adequate liver function
Adequate cardiac function
Adequate neurologic function
Adequate BP control with or without antihypertensive medications
Adequate coagulation
Adequate pancreatic function
Adequate metabolic function
Exclusion Criteria
Subjects who have had or are planning to have invasive procedures
Subjects who have non-healing wound, unhealed or incompletely healed fracture, or a compound (open) bone fracture at the time of enrollment
Clinical evidence of nephrotic syndrome prior to enrollment
Gastrointestinal bleeding or active hemoptysis (bright red blood of at least half teaspoon) within 21 days prior to enrollment
Thrombotic/ thromboembolic event requiring systemic anticoagulation within 90 days prior to enrollment
Evidence of new intracranial hemorrhage of more than punctate size on MRI assessment obtained within 28 days prior to study enrollment for subjects with HGG
Diagnosis of lymphoma
Radiographic evidence of major blood vessel invasion/infiltration.
Evidence of untreated CNS metastases
Subjects who are currently receiving enzyme-inducing anticonvulsants
Subjects chronically receiving strong cytochrome P450 3A4 (CYP3A4)/P-glycoprotein (P-gp) inhibitors or inducers within 7 days prior to study enrollment (See Appendix 15 for a list of strong inhibitors and inducers)
Females who are breastfeeding or pregnant at Screening or Baseline
Updated on
19 Feb 2024.
Study ID: 1707448889 (PHO-COG/EISAI-ADVL1711)
This study investigates the effects of a combination of investigational medications on pediatric subjects with certain types of recurrent or refractory solid tumors. The purpose is to find the highest safe dose of these medications when given together, and to understand how the body processes them. Additionally, researchers will study biomarkers in blood and tumor tissues to evaluate the effectiveness of the treatment and any changes in tumor size.
Participants will undergo various study procedures, including receiving the investigational medications once daily. The study will monitor how the body absorbs, distributes, breaks down, and excretes these drugs. Biomarkers will be assessed to help researchers understand the disease and the effects of the treatment.
- Who can participate: Children with recurrent or refractory solid tumors, including specific types like Ewing sarcoma, rhabdomyosarcoma, and high-grade gliomas, may participate. Participants must meet certain health criteria, such as adequate kidney, liver, and heart function, and must not have certain conditions like untreated CNS metastases or recent invasive procedures.
- Study details: Participants will receive a combination of investigational medications once daily. The study will include monitoring for any side effects and assessing the body's response to the medication. A placebo is not used in this study.
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