Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Gastrointestinal, Pancreatic, or Colorectal Cancer (RECITE)
Chemotherapy-induced Thrombocytopenia
About this trial
This is an interventional treatment trial for Chemotherapy-induced Thrombocytopenia focused on measuring Chemotherapy Induced Thrombocytopenia, Gastrointestinal Cancer, Colorectal Cancer, Pancreatic Cancer
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.
- 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 10⁹/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 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 109/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 3X ULN; alanine aminotransferase [ALT] or aspartate aminotransferase [AST] 3X ULN for subjects without liver metastases or 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 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.
Sites / Locations
- Saint Bernards Medical CenterRecruiting
- Pacific Cancer Medical Center IncRecruiting
- University of California IrvineRecruiting
- Colorado West Healthcare System dba Grand Valley Oncology
- Mid Florida Hematology and Oncology Centers PARecruiting
- Oncology and Hematology Associates of West Broward, PARecruiting
- Cleveland Clinic FloridaRecruiting
- Orchard Healthcare Research IncRecruiting
- Christus Saint Frances Cabrini Hospital
- University Medical Center New Orleans
- Christus Highland Cancer Treatment CenterRecruiting
- Mercy Medical Center
- American Oncology Partners of Maryland, PARecruiting
- Massachusetts General Hospital Cancer CenterRecruiting
- Beth Israel Deaconess Medical CenterRecruiting
- Hattiesburg Clinic Hematology/Oncology
- Oncology Hematology AssociatesRecruiting
- Morristown Medical Center
- Regional Cancer Care Associates
- The Center for Cancer and Blood Disorders
- Medical Oncology Associates PSRecruiting
- Yakima Valley Memorial HospitalRecruiting
- Hospital Universitario Fundacion FavaloroRecruiting
- Instituto Oncologico CordobaRecruiting
- Centro de Investigaciones Clínicas Clínica ViedmaRecruiting
- Centro de Diagnostico Investigacion y TratamientoRecruiting
- Landeskrankenhaus Steyr
- Universitaetsklinikum Allgemeines Krankenhaus Wien
- Instituto de Oncologia do ParanaRecruiting
- Vencer e OncoclinicaRecruiting
- Centro de Pesquisa da Serra Gaucha - Cepesg
- Catarina Pesquisa ClinicaRecruiting
- Loema Instituto de Pesquisa Clinica e Consultores LtdaRecruiting
- Casa de Saude Santa MarcelinaRecruiting
- Complex Oncology Center - Ruse EOODRecruiting
- Medical Center Nadezhda Clinical EOOD
- Specialized Hospital for Active Treatment of Oncology EAD
- Cape Breton Cancer Centre, Nova Scotia Health AuthorityRecruiting
- Grand River Regional Cancer Centre at Grand River Hospital
- Fundacion Colombiana de Cancerologia Clinica Vida
- Oncomedica Imat
- Centro Medico Imbanaco
- Centre Hospitalier Universitaire de BrestRecruiting
- Hôpital Européen Georges PompidouRecruiting
- Hopital FochRecruiting
- Institut Gustave RoussyRecruiting
- General Hospital of Athens Laiko
- Aretaieio HospitalRecruiting
- Evgenidio Hospital I Agia TriasRecruiting
- Attikon University HospitalRecruiting
- General Oncology Hospital of Kifissia Agioi AnargyroiRecruiting
- University Hospital of PatrasRecruiting
- Agios Loukas ClinicRecruiting
- Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
- Debreceni Egyetem Klinikai Kozpont
- Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktatokorhaz
- Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar
- Azienda Socio Sanitaria Territoriale di CremonaRecruiting
- Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano NiguardaRecruiting
- Azienda Ospedaliera Citta della Salute e della Scienza di Torino Ospedale Molinette
- OncotechRecruiting
- Centro de Atencion e Investigacion Cardiovascular del Potosi ScRecruiting
- Centro Medico Nacional Siglo XXIRecruiting
- Oaxaca Site Management Organization SCRecruiting
- Hospital Goyeneche
- Oncosalud
- Wojewodzki Szpital Specjalistyczny w Bialej PodlaskiejRecruiting
- Powiatowe Centrum Zdrowia w Brzezinach Sp Z o oRecruiting
- Uniwersytecki Szpital Kliniczny w PoznaniuRecruiting
- Uniwersytecki Szpital Kliniczny w Poznaniu
- Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa MariaRecruiting
- Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro HispanoRecruiting
- Centro Hospitalar Universitario do Porto EPE - Hospital de Santo Antonio
- Centro Hospitalar Universitario de Sao Joao, EPE - Hospital Sao JoaoRecruiting
- Centro Hospitalar Tras-os-Montes e Alto Douro EPE - Unidade de Vila RealRecruiting
- Policlinica de Diagnostic Rapid
- Fundeni Clinical Institute for Digestive Disorders and Liver TransplantationRecruiting
- Spitalul Clinic al Cailor Ferate Cluj NapocaRecruiting
- SC Medisprof SRLRecruiting
- Centrul de Oncologie Sf Nectarie SRL
- Institutul Regional de Oncologie Iasi
- SC Oncomed SRLRecruiting
- SBHI of Arkhangelsk region Arkhangelsk clinical oncology dispensaryRecruiting
- Autonomic SHI Republican clinical oncology dispensary of MoH of the Republic of TatarstanRecruiting
- Medsi GroupRecruiting
- Clinical hospital 2, Group of companies medsiRecruiting
- LLC Tonus
- Omsk Regional Clinical Oncology DispensaryRecruiting
- State budget institution of public health Pyatigorsk oncology dispensary
- State Institution of Public Health
- Leningrad Regional Oncology Dispensary na L D Roman
- FSBI Scientific and Research Oncology Institute named after N N PetrovRecruiting
- State Institution of Public Health Oncology Dispensary 2 of Public Health Krasnodar Region
- State Institution of Public Health Tambov Regional Oncology Dispensary
- Respublican clinical oncology dispensary Minzdrava of Republic of BashkortostanRecruiting
- Hospital Clinico Universitario San CecilioRecruiting
- Hospital Clinico Universitario de Salamanca
- Hospital Universitario Arnau de Vilanova LleidaRecruiting
- Hospital Universitari Sant Joan de ReusRecruiting
- Complexo Hospitalario Universitario de OurenseRecruiting
- Hospital Universitario Madrid SanchinarroRecruiting
- Baskent Universitesi Adana Doktor Turgut Noyan Uygulama ve Arastirma MerkeziRecruiting
- Doktor Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma HastanesiRecruiting
- Hacettepe Universitesi Tip FakultesiRecruiting
- Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi HastanesiRecruiting
- Ankara Bilkent Sehir HastanesiRecruiting
- Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi
- Istanbul Universitesi Onkoloji EnstitusuRecruiting
- Prof Dr Cemil Tascioglu Sehir HastanesiRecruiting
- Goztepe Prof Dr Suleyman Yalcin Sehir HastanesiRecruiting
- Ege Universitesi Tip FakultesiRecruiting
- Izmir Ekonomi Universitesi Medical Point HastanesiRecruiting
- Kocaeli Universitesi Arastirma ve Uygulama HastanesiRecruiting
- VM Medical Park Samsun Hastanesi
- Communal Institution Chernivtsi Regional Clinical Oncological DispensaryRecruiting
- Prykarpatskyy Clinical Oncology Centre
- Transcarpathian Regional Clinical Oncological DispensaryRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Romiplostim
Placebo
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.
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.