Clinical trial NCT03937154: Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Non-small Cell Lung Cancer (NSCLC), Ovarian Cancer, or Breast Cancer
Official title: PROCLAIM: A Phase 3 Randomized Placebo-controlled Double-blind Study of Romiplostim for the Treatment of Chemotherapy-induced Thrombocytopenia in Patients Receiving Chemotherapy for Treatment of Non-small Cell Lung Cancer (NSCLC), Ovarian Cancer, or Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Chemotherapy-induced Thrombocytopenia
Keywords: Chemotherapy-induced thrombocytopenia
Non-small Cell Lung Cancer
Ovarian Cancer
Breast Cancer
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2019-05-03
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will consist of a screening period of up to 4 weeks, a treatment period long enough to allow for assessment of 3 planned cycles of chemotherapy, a follow-up visit, and LTFU. Given that subjects are required to have 3 remaining planned cycles of chemotherapy, the chemotherapy cycles may be 3 or 4 weeks in duration, and the investigational product dose adjustment guidelines allow for up to 12 weeks of dosing before a subject is declared a non-responder, the majority of study subjects will receive investigational product for a range of 10-24 weeks.
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy of romiplostim for the treatment of CIT in patients receiving chemotherapy for the treatment of NSCLC, ovarian cancer, or breast cancer measured by the ability to administer on-time, full-dose chemotherapy

Detailed description: This is a phase 3, randomized, placebo-controlled, multicenter, international study for the treatment of CIT in adult subjects receiving chemotherapy for the treatment of NSCLC, ovarian cancer, or breast cancer. Subjects must have a platelet count ≤ 85 x 10\^9/L on day 1 of the study. The study will consist of a screening period of up to 4 weeks, a treatment period long enough to allow for assessment of 3 planned cycles of chemotherapy, a follow-up visit, and long-term follow-up (LTFU). Given that subjects are required to have 3 remaining planned cycles of chemotherapy, the chemotherapy cycles may be 3 or 4 weeks in duration, and the investigational product dose adjustment guidelines allow for up to 12 weeks of dosing before a subject is declared a non-responder, the majority of study subjects will receive investigational product for a range of 10-24 weeks.

Eligibility criteria: Inclusion Criteria:

* Subject has provided informed consent prior to initiation of any study-specific activities/procedures or subject's legally acceptable representative has provided informed consent prior to any study-specific activities/procedures being initiated when the subject has any kind of condition that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent.
* Males or females greater than or equal to 18 years of age at signing of the informed consent.
* Documented active stage I, II, III or IV locally advanced or metastatic of the following tumor types: NSCLC, breast cancer, or ovarian cancer (includes fallopian tube epithelial carcinomas and peritoneal epithelial carcinoma of unknown primary), or any stage recurrent disease. Patients with documented locally advanced (stage III) NSCLC should not be amenable to definitive treatment with chemoradiation and/or surgery.
* Subjects must be receiving cancer treatment with 21- or 28-day cycles, using one of the following carboplatinum-based combination chemotherapy regimens: carboplatin/gemcitabine based, carboplatin/pemetrexed based, carboplatin/liposomal doxorubicin based or carboplatin/taxane based (which includes either paclitaxel, nab-paclitaxel, or docetaxel) or single agent chemotherapy regimen with any of the above mentioned drugs. Use of combination regimens with one of the above carboplatinum-based regimens is permitted with (1) anti-angiogenic agents (such as bevacizumab); (2) targeted therapy (such as anti-epidermal growth factor agents or anti- human epidermal growth factor receptor 2) or (3) immune checkpoint inhibitors. Cycle duration is based on intervals between day 1 of chemotherapy cycles (overlapping with carboplatin intervals) every 21 or 28 day cycles for single agent regimens. OR, Subjects must have CIT from a non-protocol chemotherapy regimen, planning to start treatment with one of the above protocol chemotherapy regimens which has been delayed ≥ 1 week due to CIT.
* Subjects must have a local platelet count ≤ 85 x 109/L on day 1 of the study.
* Subjects must be at least 21 or 28 days removed from the start of the chemotherapy cycle immediately prior to study day 1 if receiving a 21-day or 28-day cycle chemotherapy regimen, respectively.
* Subjects must have at least 3 remaining planned cycles of chemotherapy at study enrollment.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

Exclusion Criteria:

* Acute lymphoblastic leukemia.
* Acute myeloid leukemia.
* Any myeloid malignancy.
* Myelodysplastic syndrome. Baseline bone marrow biopsy is not required to rule out MDS. However, if a bone marrow biopsy and cytogenetics were performed as part of diagnostic or staging work-up, these results will be collected to confirm.
* Myeloproliferative disease.
* Multiple myeloma.
* Within 4 months prior to enrollment, any history of active congestive heart failure (New York Heart Association \[NYHA\] Class III to IV), symptomatic ischemia, uncontrolled arrhythmias, clinically significant electrocardiogram (ECG) abnormalities, screening ECG with corrected QT (QTc) interval of greater than 470 msec, pericardial disease, or myocardial infarction.
* Major surgery less than or equal to 28 days or minor surgery less than or equal to 3 days prior to enrollment.
* New or uncontrolled venous thromboembolism or thrombotic events within 3 months prior to screening. To be eligible, subjects must have received at least 14 days of anticoagulation for a new thrombotic event and considered to be stable and suitable for continued therapeutic anticoagulation during trial participation.
* History of arterial thrombotic events (eg, myocardial ischemia, transient ischemic attack, or stroke) within 6 months prior to screening.
* Evidence of active infection within 2 weeks prior to the first dose of study treatment.
* Known human immunodeficiency virus infection with any detectable viral load at screening. Subjects without a documented diagnosis in their medical history will require a local laboratory assessment at screening. If local laboratory results are not available use central laboratory results.
* Known active of chronic hepatitis C or hepatitis B infection. Subjects without a documented diagnosis in their medical history will require a local laboratory assessment at screening. If local laboratory results are not available use central laboratory results. Hepatitis B and C infection is based on the following results:
* Positive for hepatitis B surface antigen (HBsAg) (indicative of chronic hepatitis B or recent acute hepatitis B).
* Negative HBsAg and positive for hepatitis B core antibody: hepatitis B virus DNA by polymerase chain reaction (PCR) is necessary. Detectable hepatitis B virus DNA suggests occult hepatitis B.
* Positive hepatitis C virus antibody: hepatitis C virus RNA by PCR is necessary. Detectable hepatitis C virus RNA suggests chronic hepatitis C.
* In addition to the conditions listed in exclusion criteria 201 through 206, secondary malignancy within the past 5 years except:
* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
* Adequately treated cervical carcinoma in situ without evidence of disease.
* Adequately treated breast ductal carcinoma in situ without evidence of disease.
* Prostatic intraepithelial neoplasia without evidence of prostate cancer.
* Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ.
* Malignancy treated with curative intent and with no known active disease present for greater than or equal to 3 years before enrollment and felt to be at low risk for recurrence by the treating physician (excluding malignancies listed in exclusion criteria 201 - 206).
* Thrombocytopenia due to another etiology other than CIT (eg, chronic liver disease, prior history of immune thrombocytopenia purpura).
* Any combined modality regimen containing radiation therapy or surgery occurring concomitantly with neo-adjuvant chemotherapy or where radiation therapy is planned during the cycle preceding 3 planned on-study cycles of chemotherapy.

Prior/Concomitant Therapy:

- Previous use of romiplostim, pegylated recombinant human megakaryocyte growth and development factor, eltrombopag, recombinant human TPO, any other TPO receptor agonist, or any investigational platelet producing agent.

Prior/Concurrent Clinical Study Experience - Currently receiving (or plan to receive) treatment in another investigational device or drug study, or less than 28 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.

Diagnostic Assessments

* Anemia (hemoglobin \< 80 g/L \[8 g/dL\]) on the day of initiation of investigational product as assessed by local labs. Use of red cell transfusions and erythropoietic stimulating agents is permitted throughout the study as per institutional guidelines.
* Neutropenia (absolute neutrophil count less than 1 x 10 9/L) on the day of initiation of investigational product as assessed by local labs. Use of granulocyte-colony stimulating factor is permitted throughout the study as per institutional guidelines.
* Abnormal renal function with creatinine clearance less than 30 mL/min using the Cockcroft-Gault estimated creatinine clearance as assessed by local laboratory. If local laboratory results are not available use central laboratory results.

during screening.

- Abnormal liver function (total bilirubin greater than 3X ULN; alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\] greater than 3X ULN for subjects without liver metastases or greater than or equal to 5X ULN for subjects with liver metastases) as assessed by local laboratory during screening. If local laboratory results are not available use central laboratory results.

Other Exclusions

* Females who are pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 7 months after treatment (and chemotherapy) discontinuation (females of childbearing potential should only be included after a confirmed menstrual period and a negative highly sensitive urine or serum pregnancy test.)
* Females of childbearing potential unwilling to use a highly effective method of contraception during treatment and for an additional 7 months after treatment (and chemotherapy) discontinuation. Refer to Appendix 5 for additional contraceptive information.
* Males unwilling to use contraception\* (male condom or sexual abstinence) or their female partner(s) of childbearing potential who are unwilling to use a highly effective method of contraception during treatment (and chemotherapy) and for an additional 7 months after treatment (and chemotherapy) discontinuation. \*If the male's sole partner is of non-childbearing potential, he is not required to use additional forms of contraception during the study.
* Subject has known sensitivity to any of the products to be administered during dosing.
* Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, COAs) to the best of the subject and investigator's knowledge.
* History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
* Male subjects with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment (and chemotherapy) and for an additional 7 months after treatment (and chemotherapy) discontinuation.
* Male subjects unwilling to abstain from donating sperm during treatment (and chemotherapy) and for an additional 7 months after treatment (and chemotherapy) discontinuation.

Primary outcomes:
measure: Incidence of either a chemotherapy dose delay or reduction
timeFrame: 48 days
Secondary outcomes:
measure: Depth of Platelet Count
timeFrame: 48 days
measure: Time to First platelet response
timeFrame: 7 days
measure: the duration-adjusted event rate of ≥ grade 2 bleeding events
timeFrame: 48 days
measure: Overall survival
timeFrame: 1 Year
measure: Proportion of subjects with at leat 1 incidence of platelet transfusion
timeFrame: 48 days
measure: proportion of patients achieving platelet count >= 100 x 10 9/L
timeFrame: 7 days
measure: The subject incidence of adverse events
timeFrame: 36 months
measure: Number of subjects who develop anti-romiplostim antibodies
timeFrame: 36 Months
measure: Number of subjects who develop anti-TPO antibodies
timeFrame: 36 months
measure: Number of subjects who experience myelodysplastic syndromes
timeFrame: 36 months
measure: Number of subjects who experience secondary malignancies
timeFrame: 36 months
Other outcomes:
Locations:
city: Jonesboro
country: United States
facility: Saint Bernards Medical Center
state: Arkansas
city: Anaheim
country: United States
facility: Los Angeles Cancer Network
state: California
city: Orange
country: United States
facility: University of California Irvine
state: California
city: Grand Junction
country: United States
facility: Colorado West Healthcare System dba Grand Valley Oncology
state: Colorado
city: Miami
country: United States
facility: University of Miami School of Medicine
state: Florida
city: Ocala
country: United States
facility: Ocala Oncology Center
state: Florida
city: Orange City
country: United States
facility: Mid Florida Hematology and Oncology Centers PA
state: Florida
city: Boise
country: United States
facility: Saint Alphonsus Regional Medical Center
state: Idaho
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Skokie
country: United States
facility: Orchard Healthcare Research Inc
state: Illinois
city: Alexandria
country: United States
facility: Christus Saint Frances Cabrini Hospital
state: Louisiana
city: New Orleans
country: United States
facility: University Medical Center New Orleans
state: Louisiana
city: Shreveport
country: United States
facility: Christus Highland Cancer Treatment Center
state: Louisiana
city: Baltimore
country: United States
facility: Mercy Medical Center
state: Maryland
city: Bethesda
country: United States
facility: American Oncology Partners, PA
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic Hematology/Oncology
state: Mississippi
city: Springfield
country: United States
facility: Oncology Hematology Associates
state: Missouri
city: Great Falls
country: United States
facility: Great Falls Clinic
state: Montana
city: Omaha
country: United States
facility: Nebraska Cancer Specialists
state: Nebraska
city: Sparta
country: United States
facility: Regional Cancer Care Associates
state: New Jersey
city: Binghamton
country: United States
facility: Broome Oncology LLC
state: New York
city: Bethlehem
country: United States
facility: Saint Lukes University Health Network
state: Pennsylvania
city: Fort Worth
country: United States
facility: The Center for Cancer and Blood Disorders
state: Texas
city: Ogden
country: United States
facility: Community Cancer Trials of Utah
state: Utah
city: Spokane
country: United States
facility: Medical Oncology Associates PS
state: Washington
city: Yakima
country: United States
facility: Yakima Valley Memorial Hospital
state: Washington
city: Ciudad de Cordoba
country: Argentina
facility: Instituto Oncologico Cordoba
state: Córdoba
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Centro Medico Austral
state: Distrito Federal
city: Viedma
country: Argentina
facility: Centro de Investigaciones Clínicas Clínica Viedma
state: Río Negro
city: Salta
country: Argentina
facility: Centro de Diagnostico Investigacion y Tratamiento
city: Innsbruck
country: Austria
facility: Medizinische Universitaet Innsbruck
city: Curitba
country: Brazil
facility: Instituto de Oncologia do Parana
state: Paraná
city: Teresina
country: Brazil
facility: Vencer e Oncoclinica
state: Piauí
city: Natal
country: Brazil
facility: Liga Norte-Riograndense Contra O Cancer
state: Rio Grande Do Norte
city: Caxias do Sul
country: Brazil
facility: Centro de Pesquisa da Serra Gaucha - Cepesg
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Associação Hospitalar Moinhos de Vento
state: Rio Grande Do Sul
city: Itajai
country: Brazil
facility: Clinica de Neoplasias Litoral
state: Santa Catarina
city: Barretos
country: Brazil
facility: Hospital de Amor
state: São Paulo
city: Campinas
country: Brazil
facility: Loema Instituto de Pesquisa Clinica e Consultores Ltda - Clinica Loema
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Casa de Saude Santa Marcelina
state: São Paulo
city: São José do Rio Preto
country: Brazil
facility: Hospital de Base de Sao Jose do Rio Preto
state: São Paulo
city: São Paulo
country: Brazil
facility: Pérola Clínica de Pesquisa e Centro de Estudos em Oncologia Ginecológica e Mamaria Ltda
city: Ruse
country: Bulgaria
facility: Complex Oncology Center - Ruse EOOD
city: Sofia
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Serdika EOOD
city: Sofia
country: Bulgaria
facility: Specialized Hospital for Active Treatment of Oncology EAD
city: Temuco
country: Chile
facility: James Lind Centro de Investigacion del Cancer
state: Cautín
city: Santiago
country: Chile
facility: Orlandi Oncologia
city: Monteria
country: Colombia
facility: Oncomedica Imat
state: Córdoba
city: Cali
country: Colombia
facility: Centro Medico Imbanaco
state: Valle Del Cauca
city: Athens
country: Greece
facility: Agios Savvas Anticancer Hospital
city: Athens
country: Greece
facility: Henry Dunant Hospital Center
city: Athens
country: Greece
facility: Sotiria General Hospital
city: Athens
country: Greece
facility: Alexandra Hospital
city: Athens
country: Greece
facility: Attikon University Hospital
city: Heraklion - Crete
country: Greece
facility: University Hospital of Heraklion
city: Thessaloniki
country: Greece
facility: Agios Loukas Clinic
city: Thessaloniki
country: Greece
facility: Iatriko Diavalkaniko Thessalonikis
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Farkasgyepu
country: Hungary
facility: Farkasgyepui Tudogyogyintezet
city: Gyor
country: Hungary
facility: Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktatokorhaz
city: Szekesfehervar
country: Hungary
facility: Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz
city: Szolnok
country: Hungary
facility: Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet
city: Torokbalint
country: Hungary
facility: Reformatus Pulmonologiai Centrum
city: La Paz
country: Mexico
facility: Oncotech
state: Baja California Sur
city: San Luis Potosi
country: Mexico
facility: Centro de Atencion e Investigacion Cardiovascular del Potosi Sc
state: San Luis Potosí
city: Mexico City
country: Mexico
facility: Phylasis Clinical Research
city: Mexico
country: Mexico
facility: Centro Medico Nacional Siglo XXI
city: Oaxaca
country: Mexico
facility: Oaxaca Site Management Organization SC
city: Toluca
country: Mexico
facility: Phylasis Clinicas Research Toluca
city: Arequipa
country: Peru
facility: Hospital Goyeneche
city: Lima
country: Peru
facility: Oncosalud
city: Brzeziny
country: Poland
facility: Powiatowe Centrum Zdrowia w Brzezinach Sp Z o o
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii im prof Franciszka Lukaszczyka w Bydgoszczy
city: Koszalin
country: Poland
facility: Szpital Wojewodzki imienia Mikolaja Kopernika w Koszalinie
city: Lublin
country: Poland
facility: Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli
city: Poznan
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Poznaniu
city: Przemysl
country: Poland
facility: Wojewodzki Szpital im Sw Ojca Pio w Przemyslu
city: Szczecin
country: Poland
facility: Uniwersytecki Szpital Kliniczny nr 2 Pum w Szczecinie
city: Walbrzych
country: Poland
facility: Specjalistyczny Szpital im dra Alfreda Sokolowskiego
city: Wroclaw
country: Poland
facility: Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii
city: Lisboa
country: Portugal
facility: Unidade Local de Saude de Santa Maria, EPE - Hospital Pulido Valente
city: Matosinhos
country: Portugal
facility: Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano
city: Porto
country: Portugal
facility: Unidade Local de Saude de Santo Antonio, EPE - Hospital de Santo Antonio
city: Porto
country: Portugal
facility: Unidade Local de Saude de Sao Joao, EPE - Hospital de Sao Joao
city: Bucharest
country: Romania
facility: Spitalul Universitar de Urgenta Elias
city: Bucharest
country: Romania
facility: Institutul Oncologic, Prof Dr Alexandru Trestioreanu
city: Bucharest
country: Romania
facility: Institutul Oncologic, Prof Dr Alexandru Trestioreanu
city: Bucharest
country: Romania
facility: Spitalul Clinic Coltea
city: Bucuresti
country: Romania
facility: Memorial Healthcare International SRL
city: Cluj Napoca
country: Romania
facility: Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
city: Cluj-Napoca
country: Romania
facility: SC Medisprof SRL
city: Craiova
country: Romania
facility: Oncolab
city: Iasi
country: Romania
facility: Institutul Regional de Oncologie Iasi
city: Ploiesti
country: Romania
facility: Spitalul Municipal Ploiesti
city: Timisoara
country: Romania
facility: SC Oncomed SRL
city: Arkhangelsk
country: Russian Federation
facility: SBHI of Arkhangelsk region Arkhangelsk clinical oncology dispensary
city: Kazan
country: Russian Federation
facility: Autonomic SHI Republican clinical oncology dispensary of MoH of the Republic of Tatarstan
city: Moscow Region
country: Russian Federation
facility: Medsi Group
city: Moscow
country: Russian Federation
facility: State Healthcare Institution Goroda Moskvi City Clinical Hospital 1
city: Moscow
country: Russian Federation
facility: Clinical hospital 2, Group of companies medsi
city: Nizhniy Novgorod
country: Russian Federation
facility: LLC Tonus
city: Omsk
country: Russian Federation
facility: Omsk Regional Clinical Oncology Dispensary
city: Pyatigorsk
country: Russian Federation
facility: State budget institution of public health Pyatigorsk oncology dispensary
city: Ryazan
country: Russian Federation
facility: State Institution of Public Health
city: Sochi
country: Russian Federation
facility: State Institution of Public Health Oncology Dispensary 2 of Public Health Krasnodar Region
city: Tambov
country: Russian Federation
facility: State Institution of Public Health Tambov Regional Oncology Dispensary
city: Ufa
country: Russian Federation
facility: Respublican clinical oncology dispensary Minzdrava of Republic of Bashkortostan
city: Granada
country: Spain
facility: Hospital Clinico Universitario San Cecilio
state: Andalucía
city: Sevilla
country: Spain
facility: Hospital Universitario Nuestra Señora de Valme
state: Andalucía
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
state: Andalucía
city: Salamanca
country: Spain
facility: Hospital Clinico Universitario de Salamanca
state: Castilla León
city: Barcelona
country: Spain
facility: Instituto Oncologico IOB
state: Cataluña
city: Castellon
country: Spain
facility: Consorcio Hospitalario Provincial de Castellon
state: Comunidad Valenciana
city: Ourense
country: Spain
facility: Hospital Santa Maria Nai
state: Galicia
city: Fuenlabrada
country: Spain
facility: Hospital Universitario de Fuenlabrada
state: Madrid
city: Madrid
country: Spain
facility: Hospital Universitario Madrid Sanchinarro
city: Ankara
country: Turkey
facility: Saglik Bilimleri Universitesi Gulhane Egitim ve Arastirma Hastanesi
city: Ankara
country: Turkey
facility: Doktor Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
city: Ankara
country: Turkey
facility: Doktor Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
city: Ankara
country: Turkey
facility: Saglik Bilimleri University Ankara Ataturk Chest Diseases and Chest Surgery Training and Research Ho
city: Ankara
country: Turkey
facility: Memorial Ankara Hastanesi
city: Ankara
country: Turkey
facility: Ankara Bilkent Sehir Hastanesi
city: Denizli
country: Turkey
facility: Pamukkale Universitesi Tip Fakultesi Hastanesi
city: Edirne
country: Turkey
facility: Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi
city: Istanbul
country: Turkey
facility: Marmara Universitesi Tip Fakultesi Hastanesi
city: Izmir
country: Turkey
facility: Izmir Katip Celebi Universitesi Ataturk Egitim ve Arastirma Hastanesi
city: Izmir
country: Turkey
facility: Izmir Ekonomi Universitesi Medical Point Hastanesi
city: Kocaeli
country: Turkey
facility: Kocaeli Universitesi Tip Fakultesi Hastanesi
city: Konya
country: Turkey
facility: Necmettin Erbakan Universitesi Tip Fakultesi Hastanesi
city: Malatya
country: Turkey
facility: Inonu Universitesi Turgut Ozal Tip Merkezi
city: Sakarya
country: Turkey
facility: Sakarya Egitim ve Arastirma Hastanesi
city: Tekirdag
country: Turkey
facility: Namik Kemal Universitesi Hastanesi
city: Chernivtsi
country: Ukraine
facility: Communal Institution Chernivtsi Regional Clinical Oncological Dispensary
city: Uzhgorod
country: Ukraine
facility: Transcarpathian Regional Clinical Oncological Dispensary
city: Vinnytsya
country: Ukraine
facility: Vinnytsya Regional Clinical Oncological Dispensary
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: