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

Who is this study for? Patients with Chemotherapy-Induced Thrombocytopenia
What treatments are being studied? Romiplostim
Status: Recruiting
Location: See all (141) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
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• 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.

Locations
United States
Arkansas
Saint Bernards Medical Center
RECRUITING
Jonesboro
California
Los Angeles Cancer Network
COMPLETED
Anaheim
University of California Irvine
COMPLETED
Orange
Colorado
Colorado West Healthcare System dba Grand Valley Oncology
TERMINATED
Grand Junction
Florida
University of Miami School of Medicine
TERMINATED
Miami
Ocala Oncology Center
COMPLETED
Ocala
Mid Florida Hematology and Oncology Centers PA
TERMINATED
Orange City
Idaho
Saint Alphonsus Regional Medical Center
TERMINATED
Boise
Illinois
University of Chicago
RECRUITING
Chicago
Orchard Healthcare Research Inc
RECRUITING
Skokie
Louisiana
Christus Saint Frances Cabrini Hospital
TERMINATED
Alexandria
University Medical Center New Orleans
TERMINATED
New Orleans
Christus Highland Cancer Treatment Center
TERMINATED
Shreveport
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Maryland
Mercy Medical Center
TERMINATED
Baltimore
American Oncology Partners, PA
RECRUITING
Bethesda
Missouri
Oncology Hematology Associates
COMPLETED
Springfield
Mississippi
Hattiesburg Clinic Hematology/Oncology
TERMINATED
Hattiesburg
Montana
Great Falls Clinic
TERMINATED
Great Falls
Nebraska
Nebraska Cancer Specialists
RECRUITING
Omaha
New Jersey
Regional Cancer Care Associates
TERMINATED
Sparta
New York
Broome Oncology LLC
TERMINATED
Binghamton
Pennsylvania
Saint Lukes University Health Network
COMPLETED
Bethlehem
Texas
The Center for Cancer and Blood Disorders
COMPLETED
Fort Worth
Utah
Community Cancer Trials of Utah
RECRUITING
Ogden
Washington
Medical Oncology Associates PS
RECRUITING
Spokane
Yakima Valley Memorial Hospital
RECRUITING
Yakima
Other Locations
Argentina
Centro Medico Austral
RECRUITING
Buenos Aires
Instituto Oncologico Cordoba
RECRUITING
Córdoba
Centro de Diagnostico Investigacion y Tratamiento
RECRUITING
Salta
Centro de Investigaciones Clínicas Clínica Viedma
RECRUITING
Viedma
Austria
Medizinische Universitaet Innsbruck
TERMINATED
Innsbruck
Brazil
Hospital de Amor
RECRUITING
Barretos
Loema Instituto de Pesquisa Clinica e Consultores Ltda - Clinica Loema
TERMINATED
Campinas
Centro de Pesquisa da Serra Gaucha - Cepesg
TERMINATED
Caxias Do Sul
Instituto de Oncologia do Parana
TERMINATED
Curitba
Clinica de Neoplasias Litoral
RECRUITING
Itajaí
Liga Norte-Riograndense Contra O Cancer
RECRUITING
Natal
Associação Hospitalar Moinhos de Vento
RECRUITING
Porto Alegre
Hospital de Base de Sao Jose do Rio Preto
RECRUITING
São José Do Rio Preto
Casa de Saude Santa Marcelina
TERMINATED
São Paulo
Pérola Clínica de Pesquisa e Centro de Estudos em Oncologia Ginecológica e Mamaria Ltda
TERMINATED
São Paulo
Vencer e Oncoclinica
RECRUITING
Teresina
Bulgaria
Complex Oncology Center - Ruse EOOD
TERMINATED
Rousse
Multiprofile Hospital for Active Treatment Serdika EOOD
TERMINATED
Sofia
Specialized Hospital for Active Treatment of Oncology EAD
TERMINATED
Sofia
Chile
Orlandi Oncologia
TERMINATED
Santiago
James Lind Centro de Investigacion del Cancer
TERMINATED
Temuco
Colombia
Oncomedica Imat
TERMINATED
Montería
Centro Medico Imbanaco
TERMINATED
Santiago De Cali
Greece
Agios Savvas Anticancer Hospital
RECRUITING
Athens
Alexandra Hospital
RECRUITING
Athens
Attikon University Hospital
TERMINATED
Athens
Henry Dunant Hospital Center
RECRUITING
Athens
Sotiria General Hospital
TERMINATED
Athens
University Hospital of Heraklion
RECRUITING
Heraklion - Crete
Metaxa Anticancer Hospital
RECRUITING
Piraeus
Agios Loukas Clinic
RECRUITING
Thessaloniki
Iatriko Diavalkaniko Thessalonikis
RECRUITING
Thessaloniki
Hungary
Semmelweis Egyetem
TERMINATED
Budapest
Farkasgyepui Tudogyogyintezet
TERMINATED
Farkasgyepű
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktatokorhaz
TERMINATED
Győr
Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz
TERMINATED
Székesfehérvár
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet
TERMINATED
Szolnok
Reformatus Pulmonologiai Centrum
TERMINATED
Törökbálint
Mexico
Phylasis Clinical Research
RECRUITING
Cuautitlán Izcalli
Oncotech
RECRUITING
La Paz
Centro Medico Nacional Siglo XXI
RECRUITING
México
Oaxaca Site Management Organization SC
RECRUITING
Oaxaca City
Centro de Atencion e Investigacion Cardiovascular del Potosi Sc
RECRUITING
San Luis Potosí City
Phylasis Clinicas Research Toluca
RECRUITING
Toluca
Peru
Hospital Goyeneche
RECRUITING
Arequipa
Oncosalud
RECRUITING
Lima
Poland
Powiatowe Centrum Zdrowia w Brzezinach Sp Z o o
TERMINATED
Brzeziny
Centrum Onkologii im prof Franciszka Lukaszczyka w Bydgoszczy
RECRUITING
Bydgoszcz
Szpital Wojewodzki imienia Mikolaja Kopernika w Koszalinie
RECRUITING
Koszalin
Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli
RECRUITING
Lublin
Uniwersytecki Szpital Kliniczny w Poznaniu
RECRUITING
Poznan
Uniwersytecki Szpital Kliniczny w Poznaniu
COMPLETED
Poznan
Wojewodzki Szpital im Sw Ojca Pio w Przemyslu
RECRUITING
Przemyśl
Uniwersytecki Szpital Kliniczny nr 2 Pum w Szczecinie
RECRUITING
Szczecin
Provita Centrum Medyczne Spzoo
RECRUITING
Tomaszów Mazowiecki
Specjalistyczny Szpital im Dra Alfreda Sokolowskiego
RECRUITING
Wałbrzych
Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii
RECRUITING
Wroclaw
Portugal
Unidade Local de Saude de Santa Maria, EPE - Hospital Pulido Valente
ACTIVE_NOT_RECRUITING
Lisbon
Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano
ACTIVE_NOT_RECRUITING
Matosinhos Municipality
Unidade Local de Saude de Santo Antonio, EPE - Hospital de Santo Antonio
ACTIVE_NOT_RECRUITING
Porto
Unidade Local de Saude de Sao Joao, EPE - Hospital de Sao Joao
ACTIVE_NOT_RECRUITING
Porto
Romania
Institutul Oncologic, Prof Dr Alexandru Trestioreanu
RECRUITING
Bucharest
Institutul Oncologic, Prof Dr Alexandru Trestioreanu
COMPLETED
Bucharest
Memorial Healthcare International SRL
RECRUITING
Bucharest
Spitalul Clinic Coltea
RECRUITING
Bucharest
Spitalul Universitar de Urgenta Elias
TERMINATED
Bucharest
Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
RECRUITING
Cluj-napoca
SC Medisprof SRL
RECRUITING
Cluj-napoca
Oncolab
RECRUITING
Craiova
Institutul Regional de Oncologie Iasi
COMPLETED
Iași
Spitalul Municipal Ploiesti
RECRUITING
Ploieşti
SC Oncomed SRL
TERMINATED
Timișoara
Russian Federation
SBHI of Arkhangelsk region Arkhangelsk clinical oncology dispensary
RECRUITING
Arkhangelsk
Autonomic SHI Republican clinical oncology dispensary of MoH of the Republic of Tatarstan
COMPLETED
Kazan'
Clinical hospital 2, Group of companies medsi
TERMINATED
Moscow
State Healthcare Institution Goroda Moskvi City Clinical Hospital 1
TERMINATED
Moscow
Medsi Group
RECRUITING
Moscow Region
LLC Tonus
COMPLETED
Nizhny Novgorod
Omsk Regional Clinical Oncology Dispensary
COMPLETED
Omsk
State budget institution of public health Pyatigorsk oncology dispensary
TERMINATED
Pyatigorsk
State Institution of Public Health
TERMINATED
Ryazan
State Institution of Public Health Oncology Dispensary 2 of Public Health Krasnodar Region
TERMINATED
Sochi
State Institution of Public Health Tambov Regional Oncology Dispensary
TERMINATED
Tambov
Respublican clinical oncology dispensary Minzdrava of Republic of Bashkortostan
COMPLETED
Ufa
Spain
Instituto Oncologico IOB
TERMINATED
Barcelona
Consorcio Hospitalario Provincial de Castellon
TERMINATED
Castellon
Hospital Universitario de Fuenlabrada
RECRUITING
Fuenlabrada
Hospital Clinico Universitario San Cecilio
RECRUITING
Granada
Hospital Universitario Madrid Sanchinarro
RECRUITING
Madrid
Hospital Santa Maria Nai
TERMINATED
Ourense
Hospital Clinico Universitario de Salamanca
TERMINATED
Salamanca
Hospital Universitario Nuestra Señora de Valme
RECRUITING
Seville
Hospital Universitario Virgen del Rocio
RECRUITING
Seville
Turkey
Ankara Bilkent Sehir Hastanesi
COMPLETED
Ankara
Doktor Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
TERMINATED
Ankara
Doktor Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
RECRUITING
Ankara
Memorial Ankara Hastanesi
TERMINATED
Ankara
Saglik Bilimleri Universitesi Gulhane Egitim ve Arastirma Hastanesi
RECRUITING
Ankara
Saglik Bilimleri University Ankara Ataturk Chest Diseases and Chest Surgery Training and Research Ho
COMPLETED
Ankara
Pamukkale Universitesi Tip Fakultesi Hastanesi
RECRUITING
Denizli
Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi
TERMINATED
Edirne
Basaksehir Cam ve Sakura Sehir Hastanesi
RECRUITING
Istanbul
Istanbul Universitesi Cerrahpasa Tip Fakultesi
TERMINATED
Istanbul
Marmara Universitesi Tip Fakultesi Hastanesi
RECRUITING
Istanbul
Izmir Ekonomi Universitesi Medical Point Hastanesi
RECRUITING
Izmir
Izmir Katip Celebi Universitesi Ataturk Egitim ve Arastirma Hastanesi
RECRUITING
Izmir
Kocaeli Universitesi Tip Fakultesi Hastanesi
RECRUITING
Kocaeli
Necmettin Erbakan Universitesi Tip Fakultesi Hastanesi
RECRUITING
Konya
Inonu Universitesi Turgut Ozal Tip Merkezi
TERMINATED
Malatya
Sakarya Egitim ve Arastirma Hastanesi
RECRUITING
Sakarya
Namik Kemal Universitesi Hastanesi
RECRUITING
Tekirdağ
Ukraine
Communal Institution Chernivtsi Regional Clinical Oncological Dispensary
RECRUITING
Chernivtsi
Transcarpathian Regional Clinical Oncological Dispensary
RECRUITING
Uzhhorod
Vinnytsya Regional Clinical Oncological Dispensary
RECRUITING
Vinnytsia
Contact Information
Primary
Amgen Call Center
medinfo@amgen.com
866-572-6436
Time Frame
Start Date: 2020-02-26
Estimated Completion Date: 2027-05-20
Participants
Target number of participants: 162
Treatments
Experimental: Romiplostim
The study in a 2:1 randomization ratio(108 subjects to romiplostim). Amgen investigational product (romiplostim or placebo) will be administered in the clinic by a qualified healthcare provider as a subcutaneous injection.
Placebo_comparator: Placebo
The study in a 2:1 randomization ratio (54 subjects to placebo) Amgen investigational product (romiplostim or placebo) will be administered in the clinic by a qualified healthcare provider as a subcutaneous injection.
Sponsors
Leads: Amgen

This content was sourced from clinicaltrials.gov