Study Of Palbociclib Combined With Chemotherapy In Pediatric Patients With Recurrent/Refractory Solid Tumors

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Study Of Palbociclib Combined With Chemotherapy In Pediatric Patients With Recurrent/Refractory Solid Tumors

Study Purpose

A study to learn about safety and find out maximum tolerable dose of palbociclib given in combination with chemotherapy (temozolomide with irinotecan or topotecan with cyclophosphamide) in children, adolescents and young adults with recurrent or refractory solid tumors (phase 1). Neuroblastoma tumor specific cohort to further evaluate antitumor activity of palbociclib in combination with topotecan and cyclophosphamide in children, adolescents, and young adults with recurrent or refractory neuroblastoma. Phase 2 to learn about the efficacy of palbociclib in combination with irinotecan and temozolomide when compared with irinotecan and temozolomide alone in the treatment of children, adolescents, and young adults with recurrent or refractory Ewing sarcoma (EWS).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	2 Years - 20 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion: 1. Histologically confirmed relapsed or refractory solid tumor as follows:

- For dose escalation and dose determination parts: Histologically confirmed relapsed or refractory solid tumor (including CNS tumors but not lymphomas).

Patients with Diffuse Intrinsic Pontine Glioma do not require histological only radiographic confirmed relapse to enroll.

- For dose expansion and tumor specific cohorts: Histologically confirmed relapsed or refractory solid tumor including but not limited to EWS, rhabdoid tumor, rhabdomyosarcoma, neuroblastoma, and medulloblastoma.

Patients with Diffuse Intrinsic Pontine Glioma do not require histological only radiographic confirmed relapse to enroll. EWS is not eligible for TOPO and CTX tumor-specific cohorts.

- For randomized Phase 2 part: Histologically confirmed Ewing sarcoma at diagnosis or at relapse, with presence of EWSR1-ETS or FUS-ETS rearrangement.

Histopathology confirmation of both EWSR1-ETS or FUS-ETS rearrangement partners is required OR availability of formalin fixed paraffin embedded (FFPE) tumor tissue sample for central testing. Patient must have relapsed or have refractory disease and at least evaluable disease in at least one site other than bone marrow that can be followed by imaging. 2. Age ≥2 and <21 years at the time of study entry. 3. Lansky performance status ≥50% for patients ≤16 years of age, or Eastern Cooperative Oncology Group (ECOG) 0, 1 or 2 for patients >16 years of age. 4. Adequate bone marrow function.

- Absolute neutrophil count ≥1000/mm3; - Platelet count ≥75,000/mm3 (transfusion independent, no platelet transfusion in past 7 days prior study entry); - Hemoglobin ≥8.5 g/dL (transfusion allowed).

5. Adequate renal function: Serum creatinine level based on age/gender must within protocol specified limits. 6. Adequate liver function, including:

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × upper limit of normal (ULN) or ≤5 × ULN for age, if attributable to disease involvement of the liver; - Total bilirubin ≤1.5 × ULN for age, unless the patient has documented Gilbert's syndrome.

Patients with documented Gilbert's syndrome are eligible if direct bilirubin is within normal ranges (≤ULN). 7. Patients enrolled to Phase 1 portion of the study and tumor specific cohorts must have measurable disease as defined by RECIST version 1.1 or modified RANO criteria for CNS disease or at least evaluable disease by INRC for neuroblastoma. The eligible patients with neuroblastoma must have at least one of the following at the time of study entry:

- Measurable tumor by CT or MRI that is avid on MIBG scan or demonstrates increased FDG uptake on PET scan; - Avid lesion on MIBG scan with positive uptake at a minimum of one site; - For disease that is not avid by MIBG-scan, at least one lesion that demonstrates increased FDG uptake on PET scan AND viable neuroblastoma confirmed by current or prior biopsy; - bone marrow involvement with more than 5% neuroblastoma cells in at least one sample from bilateral bone marrow biopsies; - In non MIBG-avid refractory soft tissue disease that does not demonstrate increased FDG uptake; lesion biopsy is required to document the presence of viable neuroblastoma, unless patient has a new soft tissue lesion (radiographic evidence of disease progression).

Patients with EWS enrolled to Phase 2 portion of the study are eligible with evaluable disease (eg, bone only disease with no soft tissue component). 8. Recovered to CTCAE Grade ≤1, or to baseline, from any non-hematological acute toxicities of prior surgery, chemotherapy, immunotherapy, radiotherapy, differentiation therapy or biologic therapy, with the exception of alopecia. 9. Serum/urine pregnancy test (for all girls ≥8 years of age) negative at screening and at the baseline visit. Exclusion: 1. Phase 1 and tumor specific cohorts: For palbociclib with IRN and TMZ combination, prior treatment with a CDK4/6 inhibitor or progression while on treatment with an IRN-containing regimen that includes TMZ. Patients who have received the combination of IRN and TMZ and did not progress while on these medications are eligible. For patients enrolling in the palbociclib with TOPO and CTX combination, prior treatment with a CDK4/6 inhibitor or progression while on treatment with a TOPO-containing regimen that includes CTX. Patients who have received the combination of TOPO and CTX and did not progress while on these medications are eligible. Phase 2 portion: prior treatment with a CDK4/6 inhibitor or progression while on treatment with an IRN-containing or TMZ-containing regimen. Patients who have received IRN and/or TMZ and did not progress while on these medications are eligible. 2. Prior intolerability to IRN and/or TMZ plus/minus palbociclib with IRN and TMZ combination and prior intolerability to TOPO and/or CTX for TOPO and CTX combination. For patients enrolled in the UK, any contraindication for IRN and/or TMZ treatment, as per the local SmPC. 3. Use of strong cytochrome P450 (CYP) 3A inhibitors or inducers within 12 days of study entry. Patients who are receiving strong uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1) inhibitors within 12 days of Cycle 1 Day 1 (C1D1) are not eligible for the palbociclib with IRN and TMZ combination. Patients who are receiving strong UGT1A1 inhibitors within 12 days of C1D1 are eligible for the palbociclib with TOPO and CTX combination (See Section 5.7.1 for list of products.) 4. Systemic anti cancer therapy within 2 weeks prior to study entry and 6 weeks for nitrosoureas. 5. Prior irradiation to >50% of the bone marrow (see Appendix 9). 6. Participation in other studies involving investigational drug(s) within 2 weeks or 5 half lives, whichever is longer, prior to study entry. 7. Major surgery within 4 weeks prior to study entry. Surgical biopsies or central line placement are not considered major surgeries. 8. For IRN and TMZ with/without palbociclib combinations: known or suspected hypersensitivity to palbociclib, dacarbazine, IRN and/or TMZ. For combination of palbociclib with TOPO and CTX: known or suspected hypersensitivity to palbociclib, TOPO and/or CTX. 9. Patients with known symptomatic brain tumors or brain metastases and require steroids, unless they have been on a stable or on a decreasing steroid dose for >14 days. 10. Patients with previously diagnosed brain metastases are eligible if they have completed their prior treatment and have recovered from the acute effects of radiation therapy or surgery prior to study entry for these metastases for at least 14 days post radiation and 4 weeks post-surgery and are neurologically stable. 11. Hereditary bone marrow failure disorder. 12. QTc >470 msec. 13. History of clinically significant or uncontrolled cardiac disease, including:

- History of or active congestive heart failure; if patient had congestive heart failure resolve and >1 year from resolution, patient will be considered eligible; - Clinically significant ventricular arrhythmia (such as ventricular tachycardia, ventricular fibrillation or Torsades de Pointes); - Diagnosed or suspected congenital or acquired prolonged QT syndrome; - Need for medications known to prolong the QT interval; - Uncorrected hypomagnesemia or hypokalemia because of potential effects on the QT interval; - Left ventricular ejection fraction <50% or shortening fraction <28%.

14. Recent or ongoing clinically significant gastrointestinal disorder that may interfere with absorption of orally administered drugs (eg, gastrectomy). 15. Evidence of serious active or uncontrolled bacterial, fungal or viral infection or known history of hepatitis B virus, hepatitis C virus, or human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness. Screening for viral hepatitis and HIV is under discretion of investigator unless required by local regulation. 16. Severe acute or chronic medical or laboratory test abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results, and in the judgment of the Investigator, would make the patient inappropriate for entry into this study. 17. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or patients who are Pfizer employees, including their family members, directly involved in the conduct of the study. 18. Fertile male patients or female patients of childbearing potential who are unwilling or unable to follow contraceptive requirements. 19. Pregnant or breastfeeding women.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03709680
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Pfizer
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Pfizer CT.gov Call Center
Principal Investigator Affiliation	Pfizer
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry, Other
Overall Status	Active, not recruiting
Countries	Brazil, Canada, Czechia, France, Germany, India, Korea, Republic of, Poland, Slovakia, Spain, Sweden, Turkey, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Ewing Sarcoma, Solid Tumors, Rhabdoid Tumor, Rhabdomyosarcoma, Neuroblastoma, Medulloblastoma, Diffuse Intrinsic Pontine Glioma

Arms & Interventions

Arms

Experimental: Phase 2 Arm A

Palbociclib in combination with irinotecan and temozolomide.

Experimental: Phase 1

Palbociclib in combination with temozolomide and irinotecan and/or with topotecan and cyclophosphamide.

Active Comparator: Phase 2 Arm B

Irinotecan and temozolomide alone.

Experimental: Phase 1 Tumor specific cohort - Neuroblastoma

Palbociclib in combination with topotecan and cyclophosphamide.

Interventions

Drug: - Palbociclib

Phase 1: Administered (oral) at 55 mg/m2, 75 mg/m2, or 40 mg/m2, or 95 mg/m2 or 115 mg/m2 on days 1-14 of a 21-day cycle Phase 1 Tumor specific cohort-Neuroblastoma and Phase 2 : Administered (oral) at 75 mg/m2 on days 1-14 of a 21-day cycle

Drug: - Temozolomide

Phase 1 and Phase 2: Administered at 100 mg/m2 (oral or intravenous), on days 1-5 of a 21-day cycle

Drug: - Irinotecan

Phase 1 and Phase 2: Administered at 50 mg/m2 (intravenous), on days 1-5 of a 21-day cycle

Drug: - Topotecan

Phase 1 only : Administered at 0.75 mg/m2 (intravenous), on days 1-5 of a 21-day cycle

Drug: - Cyclophosphamide

Phase 1 only: Administered at 250 mg/m2 (intravenous), on days 1-5 of a 21-day cycle

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Birmingham, Alabama

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University of Alabama at Birmingham/Children's of Alabama

Birmingham, Alabama, 35233

Phoenix Children's Hospital, Phoenix, Arizona

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Phoenix Children's Hospital

Phoenix, Arizona, 85016

Long Beach, California

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MemorialCare Health System - Long Beach Medical Center

Long Beach, California, 90806

Children's Hospital Los Angeles, Los Angeles, California

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Children's Hospital Los Angeles

Los Angeles, California, 90027

Oakland, California

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Children's Hospital and Research Center at Oakland

Oakland, California, 94609

Children's Hospital of Orange County, Orange, California

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Children's Hospital of Orange County

Orange, California, 92868

Lucile Packard Children's Hospital, Palo Alto, California

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Lucile Packard Children's Hospital

Palo Alto, California, 94304

UCSF Medical Center, San Francisco, California

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UCSF Medical Center

San Francisco, California, 94158

University of California San Francisco,, San Francisco, California

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University of California San Francisco,

San Francisco, California, 94158

Children's Hospital Colorado, Aurora, Colorado

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Children's Hospital Colorado

Aurora, Colorado, 80045

Children's National Hospital, Washington, District of Columbia

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Children's National Hospital

Washington, District of Columbia, 20010

UF Health Shands Hospital, Gainesville, Florida

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UF Health Shands Hospital

Gainesville, Florida, 32610

Gainesville, Florida

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University of Florida College of Medicine

Gainesville, Florida, 32610

Johns Hopkins All Children's Hospital, Saint Petersburg, Florida

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Johns Hopkins All Children's Hospital

Saint Petersburg, Florida, 33701

Saint Petersburg, Florida

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Johns Hopkins All Children's Outpatient Care Center

Saint Petersburg, Florida, 33701

Johns Hopkins All Children's Hospital, Tampa, Florida

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Johns Hopkins All Children's Hospital

Tampa, Florida, 33612

Atlanta, Georgia

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Children's Healthcare of Atlanta at Egleston

Atlanta, Georgia, 30322

Atlanta, Georgia

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Children's Healthcare of Atlanta at Scottish Rite

Atlanta, Georgia, 30342

Atlanta, Georgia

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Children's Healthcare of Atlanta, Medical Office Building

Atlanta, Georgia, 30342

Chicago, Illinois

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Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611

Indiana University, Indianapolis, Indiana

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Indiana University

Indianapolis, Indiana, 46202

Norton Children's Hospital, Louisville, Kentucky

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Norton Children's Hospital

Louisville, Kentucky, 40202

Novak Center for Children's Health, Louisville, Kentucky

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Novak Center for Children's Health

Louisville, Kentucky, 40202

Johns Hopkins University, Baltimore, Maryland

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Johns Hopkins University

Baltimore, Maryland, 21287

University of Michigan Health System, Ann Arbor, Michigan

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University of Michigan Health System

Ann Arbor, Michigan, 48109

Minneapolis, Minnesota

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University of Minnesota Masonic Children's Hospital

Minneapolis, Minnesota, 55454

Minneapolis, Minnesota

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University of Minnesota Medical Center, Fairview

Minneapolis, Minnesota, 55455

Minneapolis, Minnesota

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University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota, 55455

University of Minnesota, Minneapolis, Minnesota

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University of Minnesota

Minneapolis, Minnesota, 55455

University of Mississippi Medical Center, Jackson, Mississippi

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University of Mississippi Medical Center

Jackson, Mississippi, 39216

Children's Mercy Hospital, Kansas City, Missouri

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Children's Mercy Hospital

Kansas City, Missouri, 64108

Washington University School of Medicine, Saint Louis, Missouri

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Washington University School of Medicine

Saint Louis, Missouri, 63110

Robert Wood Johnson University Hospital, New Brunswick, New Jersey

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Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08901

Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey

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Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903

Montefiore Medical Center, Bronx, New York

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Montefiore Medical Center

Bronx, New York, 10467

John R. Oishei Childrens Hospital, Buffalo, New York

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John R. Oishei Childrens Hospital

Buffalo, New York, 14203

Roswell Park Cancer Institute, Buffalo, New York

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Roswell Park Cancer Institute

Buffalo, New York, 14263

Cohen Children's Medical Center, New Hyde Park, New York

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Cohen Children's Medical Center

New Hyde Park, New York, 11040

New York, New York

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Morgan Stanley Children's Hospital of New York-Presbyetrian Hospital

New York, New York, 10032

Cincinnati, Ohio

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Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

Cleveland, Ohio

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University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106

Nationwide Children's Hospital, Columbus, Ohio

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Nationwide Children's Hospital

Columbus, Ohio, 43205

Cincinnati Children's Liberty Campus, Liberty Township, Ohio

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Cincinnati Children's Liberty Campus

Liberty Township, Ohio, 45044

Oklahoma City, Oklahoma

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University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104

Oregon Health & Science University, Portland, Oregon

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Oregon Health & Science University

Portland, Oregon, 97239

Hershey, Pennsylvania

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Penn State Children's Hospital and Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033

Philadelphia, Pennsylvania

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Buerger Center for Advanced Pediatric Care

Philadelphia, Pennsylvania, 19104

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania

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Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

UPMC Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania

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UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224

Children's Blood and Cancer Center, Austin, Texas

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Children's Blood and Cancer Center

Austin, Texas, 78723

Dell Children's Medical Center, Austin, Texas

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Dell Children's Medical Center

Austin, Texas, 78723

Children's Medical Center Dallas, Dallas, Texas

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Children's Medical Center Dallas

Dallas, Texas, 75235

Cook Children's Medical Center, Fort Worth, Texas

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Cook Children's Medical Center

Fort Worth, Texas, 76104

Cook Children's H/O Infusion Center, Grapevine, Texas

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Cook Children's H/O Infusion Center

Grapevine, Texas, 76051

Texas Children's Hospital, Houston, Texas

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Texas Children's Hospital

Houston, Texas, 77030

Children's Medical Center Plano, Plano, Texas

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Children's Medical Center Plano

Plano, Texas, 75024

Salt Lake City, Utah

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Intermountain - Primary Children's Hospital

Salt Lake City, Utah, 84113

Salt Lake City, Utah

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Primary Children's Hospital Outpatient Services

Salt Lake City, Utah, 84113

Norfolk, Virginia

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Children's Hospital of The King's Daughters

Norfolk, Virginia, 23507

Children's Hospital of Richmond at VCU, Richmond, Virginia

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Children's Hospital of Richmond at VCU

Richmond, Virginia, 23219

Seattle Children's Hospital, Seattle, Washington

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Seattle Children's Hospital

Seattle, Washington, 98105

Children's Wisconsin, Milwaukee, Wisconsin

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Children's Wisconsin

Milwaukee, Wisconsin, 53226

Medical College of Wisconsin, Milwaukee, Wisconsin

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Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

International Sites

Curitiba, Paraná, Brazil

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Hospital Pequeno Principe / A ssociacao Hospitalar de Protecao a Infancia

Curitiba, Paraná, 80250-060

Hospital Pequeno Príncipe, Curitiba, Paraná, Brazil

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Hospital Pequeno Príncipe

Curitiba, Paraná, 80250-060

Hospital de Clinicas de Porto Alegre, Porto Alegre, RIO Grande DO SUL, Brazil

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Hospital de Clinicas de Porto Alegre

Porto Alegre, RIO Grande DO SUL, 90035-903

Hospital de Clinicas de Porto Alegre, Porto Alegre, RIO Grande DO SUL, Brazil

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Hospital de Clinicas de Porto Alegre

Porto Alegre, RIO Grande DO SUL, 90410000

Barretos, SÃO Paulo, Brazil

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Fundação Pio XII - Hospital de Câncer de Barretos

Barretos, SÃO Paulo, 14784400

Instituto Nacional de Câncer - INCA, Rio de Janeiro, Brazil

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Instituto Nacional de Câncer - INCA

Rio de Janeiro, , 20230-130

Hospital Santa Marcelina, São Paulo, Brazil

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Hospital Santa Marcelina

São Paulo, , 08270-070

Alberta Children's Hospital, Calgary, Alberta, Canada

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Alberta Children's Hospital

Calgary, Alberta, T3B 6A8

Stollery Children's Hospital, Edmonton, Alberta, Canada

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Stollery Children's Hospital

Edmonton, Alberta, T6G 2B7

The Hospital for Sick Children, Toronto, Ontario, Canada

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The Hospital for Sick Children

Toronto, Ontario, M5G 1X8

CHU Sainte-Justine, Montreal, Quebec, Canada

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CHU Sainte-Justine

Montreal, Quebec, H3T 1C5

Detska nemocnice FN Brno, Brno, Brno-město, Czechia

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Detska nemocnice FN Brno

Brno, Brno-město, 613 00

Fakultni nemocnice v Motole, Praha, Praha 5, Czechia

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Fakultni nemocnice v Motole

Praha, Praha 5, 150 06

Bordeaux, Aquitaine, France

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Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

Bordeaux, Aquitaine, 33076

Centre Leon Berard, Lyon, Rhône-alpes, France

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Centre Leon Berard

Lyon, Rhône-alpes, 69008

Centre Leon Berard, Lyon, Rhône-alpes, France

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Centre Leon Berard

Lyon, Rhône-alpes, 69373 CEDEX 08

Gustave Roussy, Villejuif, Val-de-marne, France

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Gustave Roussy

Villejuif, Val-de-marne, 94800

Marseille, France

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Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone

Marseille, , 13385

Universitätsklinikum Essen, Essen, Nordrhein-westfalen, Germany

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Universitätsklinikum Essen

Essen, Nordrhein-westfalen, 45122

All India Institute of Medical Sciences, New Delhi, Delhi, India

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All India Institute of Medical Sciences

New Delhi, Delhi, 110029

New Delhi, Delhi, India

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Rajiv Gandhi Cancer Institute And Research Centre

New Delhi, Delhi, 110085

Artemis hospital, Gurugram, Haryana, India

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Artemis hospital

Gurugram, Haryana, 122001

National Cancer Center, Goyang-si, Kyǒnggi-do, Korea, Republic of

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National Cancer Center

Goyang-si, Kyǒnggi-do, 10408

Seoul National University Hospital, Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of

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Seoul National University Hospital

Seoul, Seoul-teukbyeolsi [seoul], 03080

Asan Medical Center, Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of

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Asan Medical Center

Seoul, Seoul-teukbyeolsi [seoul], 05505

Samsung Medical Center, Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of

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Samsung Medical Center

Seoul, Seoul-teukbyeolsi [seoul], 06351

Instytut Matki i Dziecka, Warsaw, Mazowieckie, Poland

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Instytut Matki i Dziecka

Warsaw, Mazowieckie, 01-211

Banska Bystrica, Slovakia

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Detska fakultna nemocnica s poliklinikou Banska Bystrica

Banska Bystrica, , 974 09

Narodny ustav detskych chorob, Bratislava, Slovakia

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Narodny ustav detskych chorob

Bratislava, , 83340

Hospital Universitari Vall d'Hebron, Barcelona, Barcelona [barcelona], Spain

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Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [barcelona], 08035

Madrid, Madrid, Comunidad DE, Spain

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Hospital Infantil Universitario Niño Jesús

Madrid, Madrid, Comunidad DE, 28009

Sahlgrenska Universitetssjukhuset Östra, Gothenburg, Västra Götalands LÄN [se-14], Sweden

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Sahlgrenska Universitetssjukhuset Östra

Gothenburg, Västra Götalands LÄN [se-14], 416 50

Ege Universitesi Hastanesi, İzmir, İ̇zmir, Turkey

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Ege Universitesi Hastanesi

İzmir, İ̇zmir, 35100

Hacettepe Universite Hastaneleri, Ankara, Turkey

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Hacettepe Universite Hastaneleri

Ankara, , 06100

Royal Victoria Infirmary, Newcastle upon Tyne, England, United Kingdom

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Royal Victoria Infirmary

Newcastle upon Tyne, England, NE1 4LP

Royal Hospital for Children, Glasgow, Scotland, United Kingdom

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Royal Hospital for Children

Glasgow, Scotland, G51 4TF

Leeds General Infirmary, Leeds, United Kingdom

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Leeds General Infirmary

Leeds, , LS1 3EX

London, United Kingdom

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Address

University College London Hospital, NHS Foundation Trust

London, , NW1 2PG

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