Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Gastrointestinal, Pancreatic, or Colorectal Cancer (RECITE)

RECITE: A Phase 3 Randomized Placebo-controlled Double-blind Study of Romiplostim for the Treatment of Chemotherapy- Induced Thrombocytopenia in Patients Receiving Oxaliplatin-based Chemotherapy for Treatment of Gastrointestinal, Pancreatic, or Colorectal Cancer

Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects with Gastrointestinal, Pancreatic, or Colorectal Cancer

Study Overview

• Status: Completed
• Conditions: Chemotherapy-induced Thrombocytopenia
• Intervention / Treatment: Other: Placebo; Biological: Romiplostim

Detailed Description

RECITE: A phase 3 Randomized Placebo-controlled Double-blind Study of Romiplostim for the Treatment of Chemotherapy-induced Thrombocytopenia in Patients Receiving Oxaliplatin-based Chemotherapy for Treatment of Gastrointestinal, Pancreatic, or Colorectal Cancer

• Study Type: Interventional
• Enrollment (Actual): 165
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Salta, Argentina, 4400
    • Centro de Diagnostico Investigacion y Tratamiento
  • Buenos Aires
    • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1093AAS
      • Hospital Universitario Fundacion Favaloro
  • Córdoba Province
    • Córdoba, Córdoba Province, Argentina, 5003
      • Instituto Oncologico Cordoba
  • Río Negro Province
    • Viedma, Río Negro Province, Argentina, 8500
      • Centro de Investigaciones Clínicas Clínica Viedma
• Austria
  • Steyr, Austria, 4400
    • Landeskrankenhaus Steyr
  • Vienna, Austria, 1090
    • Universitaetsklinikum Allgemeines Krankenhaus Wien
• Brazil
  • Paraná
    • Curitiba, Paraná, Brazil, 80530-010
      • Instituto de Oncologia do Parana
  • Piauí
    • Teresina, Piauí, Brazil, 64049-200
      • Vencer e Oncoclinica
  • Rio Grande do Sul
    • Caxias do Sul, Rio Grande do Sul, Brazil, 95020-450
      • Centro de Pesquisa da Serra Gaucha - Cepesg
  • Santa Catarina
    • Itajaí, Santa Catarina, Brazil, 88301-220
      • Catarina Pesquisa Clinica
  • São Paulo
    • Campinas, São Paulo, Brazil, 13010-001
      • Loema Instituto de Pesquisa Clinica e Consultores Ltda
    • São Paulo, São Paulo, Brazil, 08270-120
      • Casa de Saude Santa Marcelina
• Bulgaria
  • Rousse, Bulgaria, 7002
    • Complex Oncology Center - Ruse EOOD
  • Sofia, Bulgaria, 1330
    • Medical Center Nadezhda Clinical EOOD
  • Sofia, Bulgaria, 1756
    • Specialized Hospital for Active Treatment of Oncology EAD
• Canada
  • Nova Scotia
    • Sydney, Nova Scotia, Canada, B1P 1P3
      • Cape Breton Cancer Centre, Nova Scotia Health Authority
  • Ontario
    • Kitchener, Ontario, Canada, N2G 1G3
      • Grand River Regional Cancer Centre at Grand River Hospital
• Colombia
  • Antioquia
    • Medellín, Antioquia, Colombia, 050030
      • Fundacion Colombiana de Cancerologia Clinica Vida
  • Departamento de Córdoba
    • Montería, Departamento de Córdoba, Colombia, 230002
      • Oncomedica Imat
  • Valle del Cauca Department
    • Cali, Valle del Cauca Department, Colombia, 760042
      • Centro Médico Imbanaco
• France
  • Brest, France, 29609
    • Centre Hospitalier Universitaire de Brest
  • Paris, France, 75015
    • Hopital Europeen Georges Pompidou
  • Suresnes, France, 92150
    • Hopital Foch
  • Villejuif, France, 94805
    • Institut Gustave Roussy
• Greece
  • Athens, Greece, 12462
    • Attikon University Hospital
  • Athens, Greece, 14564
    • General Oncology Hospital of Kifissia Agioi Anargyroi
  • Athens, Greece, 11528
    • Aretaieio Hospital
  • Athens, Greece, 11528
    • Evgenidio Hospital I Agia Trias
  • Athens, Greece, 11526
    • General Hospital of Athens Laiko
  • Pátrai, Greece, 26504
    • University Hospital of Patras
  • Thessaloniki, Greece, 55236
    • Agios Loukas Clinic
• Hungary
  • Budapest, Hungary, 1097
    • Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont
  • Győr, Hungary, 9024
    • Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktatokorhaz
  • Szeged, Hungary, 6720
    • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar
• Italy
  • Cremona, Italy, 26100
    • Azienda Socio Sanitaria Territoriale di Cremona
  • Milan, Italy, 20162
    • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
  • Torino, Italy, 10126
    • Azienda Ospedaliera Citta della Salute e della Scienza di Torino Ospedale Molinette
• Mexico
  • México, Mexico, 06720
    • Centro Médico Nacional Siglo XXI
  • Oaxaca City, Mexico, 68000
    • Oaxaca Site Management Organization SC
  • Baja California Sur
    • La Paz, Baja California Sur, Mexico, 23040
      • Oncotech
  • San Luis Potosí
    • San Luis Potosí City, San Luis Potosí, Mexico, 78200
      • Centro de Atencion e Investigacion Cardiovascular del Potosi Sc
• Peru
  • Arequipa, Peru, 04001
    • Hospital Goyeneche
  • Lima, Peru, 15036
    • Oncosalud
• Poland
  • Biała Podlaska, Poland, 21-500
    • Wojewodzki Szpital Specjalistyczny w Bialej Podlaskiej
  • Brzeziny, Poland, 95-060
    • Powiatowe Centrum Zdrowia w Brzezinach Sp Z o o
  • Poznan, Poland, 60-569
    • Uniwersytecki Szpital Kliniczny w Poznaniu
  • Poznan, Poland, 60-780
    • Uniwersytecki Szpital Kliniczny w Poznaniu
• Portugal
  • Lisbon, Portugal, 1649-035
    • Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria
  • Matosinhos Municipality, Portugal, 4464-513
    • Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano
  • Porto, Portugal, 4099-001
    • Centro Hospitalar Universitario do Porto, EPE - Hospital de Santo Antonio
  • Porto, Portugal, 4200-319
    • Centro Hospitalar Universitario de Sao Joao, EPE - Hospital Sao Joao
  • Vila Real, Portugal, 5000-508
    • Centro Hospitalar Tras-os-Montes e Alto Douro EPE - Unidade de Vila Real
• Romania
  • Brasov, Romania, 500152
    • Policlinica de Diagnostic Rapid
  • Bucharest, Romania, 022328
    • Fundeni Clinical Institute for Digestive Disorders and Liver Transplantation
  • Cluj-Napoca, Romania, 400015
    • Spitalul Clinic al Cailor Ferate Cluj Napoca
  • Cluj-Napoca, Romania, 400124
    • SC Medisprof SRL
  • Craiova, Romania, 200347
    • Centrul de Oncologie Sf Nectarie SRL
  • Iași, Romania, 700483
    • Institutul Regional de Oncologie Iasi
  • Timișoara, Romania, 300239
    • SC Oncomed SRL
• Russia
  • Arkhangelsk, Russia, 163045
    • SBHI of Arkhangelsk region Arkhangelsk clinical oncology dispensary
  • Kazan', Russia, 420029
    • Autonomic SHI Republican clinical oncology dispensary of MoH of the Republic of Tatarstan
  • Moscow, Russia, 125284
    • Clinical hospital 2, Group of companies medsi
  • Moscow Region, Russia, 143442
    • Medsi Group
  • Nizhny Novgorod, Russia, 603089
    • LLC Tonus
  • Omsk, Russia, 644013
    • Omsk Regional Clinical Oncology Dispensary
  • Pyatigorsk, Russia, 357502
    • State budget institution of public health Pyatigorsk oncology dispensary
  • Ryazan, Russia, 390011
    • State Institution of Public Health
  • Saint Petersburg, Russia, 197758
    • FSBI Scientific and Research Oncology Institute named after N N Petrov
  • Saint Petersburg, Russia, 191104
    • Leningrad Regional Oncology Dispensary na L D Roman
  • Sochi, Russia, 354057
    • State Institution of Public Health Oncology Dispensary 2 of Public Health Krasnodar Region
  • Tambov, Russia, 390013
    • State Institution of Public Health Tambov Regional Oncology Dispensary
  • Ufa, Russia, 450054
    • Respublican clinical oncology dispensary Minzdrava of Republic of Bashkortostan
• Spain
  • Madrid, Spain, 28050
    • Hospital Universitario Madrid Sanchinarro
  • Andalusia
    • Granada, Andalusia, Spain, 18016
      • Hospital Clinico Universitario San Cecilio
  • Castille and León
    • Salamanca, Castille and León, Spain, 37007
      • Hospital Clínico Universitario de Salamanca
  • Catalonia
    • Lleida, Catalonia, Spain, 25198
      • Hospital Universitario Arnau de Vilanova Lleida
    • Reus, Catalonia, Spain, 43204
      • Hospital Universitari Sant Joan de Reus
  • Galicia
    • Ourense, Galicia, Spain, 32005
      • Complexo Hospitalario Universitario de Ourense
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 01250
    • Baskent Universitesi Adana Doktor Turgut Noyan Uygulama ve Arastirma Merkezi
  • Ankara, Turkey (Türkiye), 06800
    • Ankara Bilkent Sehir Hastanesi
  • Ankara, Turkey (Türkiye), 06560
    • Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi
  • Ankara, Turkey (Türkiye), 06230
    • Hacettepe Universitesi Tip Fakultesi
  • Ankara, Turkey (Türkiye), 06200
    • Doktor Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
  • Edirne, Turkey (Türkiye), 22030
    • Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi
  • Istanbul, Turkey (Türkiye), 34722
    • Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi
  • Istanbul, Turkey (Türkiye), 34093
    • Istanbul Üniversitesi Onkoloji Enstitüsü
  • Istanbul, Turkey (Türkiye), 34384
    • Prof Dr Cemil Tascioglu Sehir Hastanesi
  • Izmir, Turkey (Türkiye), 35100
    • Ege Universitesi Tip Fakultesi
  • Izmir, Turkey (Türkiye), 35575
    • Izmir Ekonomi Universitesi Medical Point Hastanesi
  • Kocaeli, Turkey (Türkiye), 41380
    • Kocaeli Üniversitesi Araştirma Ve Uygulama Hastanesi
  • Samsun, Turkey (Türkiye), 55200
    • VM Medical Park Samsun Hastanesi
• Ukraine
  • Chernivtsi, Ukraine, 58013
    • Communal Institution Chernivtsi Regional Clinical Oncological Dispensary
  • Ivano-Frankivsk, Ukraine, 76018
    • Prykarpatskyy Clinical Oncology Centre
  • Uzhhorod, Ukraine, 88000
    • Transcarpathian Regional Clinical Oncological Dispensary
• United States
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • Saint Bernards Medical Center
  • California
    • Anaheim, California, United States, 92801
      • Pacific Cancer Medical Center INC
    • Orange, California, United States, 92868
      • University of California Irvine
  • Colorado
    • Grand Junction, Colorado, United States, 81505
      • Colorado West Healthcare System dba Grand Valley Oncology
  • Florida
    • Orange City, Florida, United States, 32763
      • Mid Florida Hematology and Oncology Centers PA
    • Tamarac, Florida, United States, 33321
      • Oncology and Hematology Associates of West Broward, PA
    • Weston, Florida, United States, 33331
      • Cleveland Clinic Florida
  • Illinois
    • Skokie, Illinois, United States, 60076
      • Orchard Healthcare Research Inc
  • Louisiana
    • Alexandria, Louisiana, United States, 71301
      • Christus Saint Frances Cabrini Hospital
    • New Orleans, Louisiana, United States, 70112
      • University Medical Center New Orleans
    • Shreveport, Louisiana, United States, 71105
      • Christus Highland Cancer Treatment Center
  • Maryland
    • Baltimore, Maryland, United States, 21202
      • Mercy Medical Center
    • Bethesda, Maryland, United States, 20817
      • American Oncology Partners, PA
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital Cancer Center
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39401
      • Hattiesburg Clinic Hematology/Oncology
  • Missouri
    • Springfield, Missouri, United States, 65807
      • Oncology Hematology Associates
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Morristown Medical Center
    • Sparta, New Jersey, United States, 78071
      • Regional Cancer Care Associates
  • Texas
    • Fort Worth, Texas, United States, 76104
      • The Center for Cancer and Blood Disorders
  • Washington
    • Spokane, Washington, United States, 99208
      • Medical Oncology Associates PS
    • Yakima, Washington, United States, 98902
      • Yakima Valley Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.
• Histologically or cytologically confirmed diagnosis of gastrointestinal, pancreatic, or colorectal adenocarcinoma, defined as cancers of the esophagus (including esophagogastric junction [EGJ] cancer), stomach, pancreas, colon, or rectum. Tumor stage will not affect eligibility.
• Subjects must be receiving 1 of the following regimens: An oxaliplatin-based chemotherapy regimen, containing 5 FU or capecitabine plus oxaliplatin (irinotecan may be added for FOLFIRINOX or FOLFOXIRI) on a 14- or 21 day schedule, respectively; OR, subjects must have chemotherapy-induced thrombocytopenia from a non-protocol chemotherapy regimen, planning to start treatment with one of the protocol chemotherapy regimens which has been delayed greater than or equal to one week due to chemotherapy-induced thrombocytopenia. Note: Use of these regimens are permitted with (1) anti angiogenic agents (such as bevacizumab) or (2) targeted therapy (such as anti epidermal growth factor receptor agents);
• Subjects must have a local platelet count ≤ 85 x 10^9/L on study day 1.
• Subjects must be at least 14 days removed from the start of the chemotherapy cycle immediately prior to study day 1 if they received FOLFOX, FOLFIRINOX or FOLFOXIRI, and 21 days removed if they received CAPEOX.
• 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:

Previous or Current Medical Conditions

• 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 > 470 msec, pericardial disease, or myocardial infarction.
• Major surgery ≤ 28 days or minor surgery ≤ 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 both stable and suitable for continued therapeutic anticoagulation during trial participation.
• History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months of screening.
• Evidence of active infection within 2 weeks prior to first dose of study treatment.
• Known human immunodeficiency virus 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.
• Known active chronic hepatitis B or C 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 (HCVAb): hepatitis C virus RNA by PCR is necessary. Detectable hepatitis C virus RNA suggests chronic hepatitis C.
• 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 at least 3 years before enrollment and felt to be at low risk for recurrence by the treating physician
• Thrombocytopenia due to another etiology other than CIT (eg, chronic liver disease, prior history of immune thrombocytopenia purpura).

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 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 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 < 30 mL/min using the Cockcroft-Gault estimated creatinine clearance as assessed by local laboratory during screening. If local laboratory results are not available, use central laboratory results.
• Abnormal liver function (total bilirubin > 3 X ULN; alanine aminotransferase [ALT] or aspartate aminotransferase [AST] > 3 X ULN for subjects without liver metastases or ≥ 5 X 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 6 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 6 months after treatment (and chemotherapy) discontinuation.

• 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 6 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 period of 6 months after treatment (and chemotherapy) discontinuation.
• Male subjects unwilling to abstain from donating sperm during treatment (and chemotherapy) and for an additional 6 months after treatment (and chemotherapy) discontinuation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Romiplostim; Participants will be enrolled to the study in a 2:1 randomization ratio. Amgen investigational product (romiplostim or placebo) will be administered in the clinic by a qualified healthcare provider as a subcutaneous injection.	Biological: Romiplostim; This study is designed to study Romiplostim for the treatment of chemotherapy-induced thrombocytopenia (CIT) in patients receiving chemotherapy for the treatment of gastrointestinal/colorectal/pancreatic cancer.
Placebo Comparator: Placebo; Participants will be enrolled to the study in a 2:1 randomization ratio. Amgen investigational product (romiplostim or placebo) will be administered in the clinic by a qualified healthcare provider as a subcutaneous injection.	Other: Placebo; Placebo Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Had Thrombocytopenia-induced Dose Modification	Participants met the criteria of the primary endpoint if there was no thrombocytopenia-induced modification of any myelosuppressive treatment agent in the second and third cycles of the planned on-trial chemotherapy regimen (cycles were up to 3 weeks). A thrombocytopenia-induced modification was defined as any dose reduction, dose delay, dose omission, and/or early chemotherapy treatment discontinuation due to low platelet counts less than 100 x 10^9/L. The 95% confidence interval (CI) is based on the exact Clopper-Pearson method.	Day 1 up to Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Platelet Count Nadir at the End of the Treatment Period	The platelet count nadir from the first on-trial chemotherapy through the end of the treatment period is presented. The least squares (LS) mean platelet count nadirs were estimated using a general linear model which included treatment, stratification factors, and the interaction between treatment and the stratification factors (tumor type and baseline platelet count).	Up to 21 weeks
Kaplan-Meier Estimate of Time to First Platelet Response	Platelet response was defined as achieving a platelet count of ≥ 100 x 10^9/L in the absence of platelet transfusions during the preceding 7 days. Participants who did not achieve a response event during the treatment period were censored at their last platelet count assessment up to end of treatment period or at the randomization date if they did not have any post-baseline platelet assessments.	Up to 21 weeks
Duration-adjusted Event Rate of Bleeding Events in the Treatment Period	The duration-adjusted adverse event (AE) incidence rate was the number of events per 100 subject-years from the trial day 1 until the date of last dose of investigational product + 30 days, or end of trial, whichever is earlier. It was calculated as: duration-adjusted event rate per 100 subject years (n/Subj-yr) x 100. The duration-adjusted event rate was assessed for Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade 2 bleeding events. CTCAE grading for AEs ranges from Grade 1 (mild) to Grade 5 (death related to AE). Grade 2 AEs were moderate.	Up to 21 weeks
Overall Survival	Overall survival was defined as the time calculated from trial Day 1 to death. Participants who did not died were censored.	From Day 1 up to 1 year after last dose of investigational product (IP) (max 1869 days)
Percentage of Participants Who Had Platelet Transfusions During the Treatment Period	Participants who had at least 1 platelet transfusion during the treatment period.	Up to 21 weeks
Percentage of Participants Who Achieved a Platelet Count ≥ 100 x 10^9/L	The number of participants who achieved a platelet count ≥ 100 x 10^9/L at any time after trial Day 1 to Week 4 (7 days after the planned third dose of IP). If a platelet transfusion occurred during the 7 days preceding a platelet count, then that platelet count was not considered as achieving the endpoint even if it is ≥ 100 x 109/L. Participants who had no platelet counts during this period were considered as not achieving achieved a platelet count ≥ 100 x 109/L. For participants who never received IP, the participants are considered as not achieving a platelet count ≥ 100 x 109/L. Weeks with no platelet count measurements (missing data) were considered as not achieving a platelet count ≥ 100 x 109/L.	Day 1 to Week 4
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs), Serious AEs (SAEs) and Fatal AEs	An AE was defined as any untoward medical occurrence in a clinical trial participant. A TEAE was an AE that started on or after the first dose of IP up to 30 days after the end of investigational product or last dose of on-trial chemotherapy (up to 3 cycles), whichever occurs later. Clinically significant changes in laboratory values were considered AEs. A SAE was defined as any untoward medical occurrence that, met at least 1 ofthe following criteria: resulted in death (fatal), immediately life-threatening,required in-patient hospitalization or prolongation of existing hospitalization,resulted in persistent or significant disability/incapacity or was a congenitalanomaly/birth defect.	From first dose of IP to 30 days after last dose of IP: median (min, max) duration was 86.0 (31.0, 184.0) days
Number of Participants Who Developed Anti-romiplostim Antibodies and Anti-thrombopoietin (TPO) Antibodies	Blood samples were collected from all participants for the measurement of anti-romiplostim and anti-TPO binding antibodies. Participants were tested for the presence of anti-romiplostim and anti-TPO antibodies at baseline (pre-existing antibody) and post-baseline (developed antibody). Samples testing positive for binding antibodies were also be tested for neutralizing antibodies.	Up to 21 weeks
Number of Participants Who Reported Myelodysplastic Syndromes (MDS) and SecondaryMalignancies	Events were identified using narrow search of pre-defined list of preferred terms for myelodysplastic syndromes (SMQ). Secondary malignancies included progression from myelodysplastic syndrome to acute myeloid leukemia (AML).	From Day 1 up to 1 year after last dose of IP (max 1869 days)

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2019
• Primary Completion (Actual): January 25, 2024
• Study Completion (Actual): January 9, 2025

Study Registration Dates

• First Submitted: October 12, 2017
• First Submitted That Met QC Criteria: November 29, 2017
• First Posted (Actual): December 5, 2017

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Pancreatic Cancer; Colorectal Cancer; Gastrointestinal Cancer; Chemotherapy Induced Thrombocytopenia
• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Intestinal Diseases; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Colonic Diseases; Colorectal Neoplasms; Pancreatic Neoplasms; Gastrointestinal Neoplasms; romiplostim
• Other Study ID Numbers: 20140346; 2017-002992-25 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
• IPD Sharing Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• IPD Sharing Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No