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

Primary Purpose

Chemotherapy-induced Thrombocytopenia

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Romiplostim
Placebo
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Placebo Comparator

Arm Label

Romiplostim

Placebo

Arm Description

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.

Outcomes

Primary Outcome Measures

Incidence of a Thrombocytopenia-induced chemotherapy dose modification during the second or third on study chemotherapy cycles.
No thrombocytopenia-induced modification of any myelosuppressive treatment agent in the second and third cycles of the planned on-study chemotherapy regimen. Thrombocytopenia-induced modifications include chemotherapy dose reduction, delay, omission, or chemotherapy treatment discontinuation due to platelet counts below 100 x 10 9/L

Secondary Outcome Measures

Depth of Platelet Count
the depth of the platelet count nadir from the start of the first on-study chemotherapy cycle through the end of the treatment period
First platelet response
The time to first platelet response, defined by platelet count ≥ 100 x 109/L in the absence of platelet transfusions during the preceding 7 days
Bleeding Events
the duration-adjusted event rate of ≥ grade 2 bleeding events, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grading scale
Overall Survival
1-year overall survival
Subject incidence of Platelet Transfusion
platelet transfusion(s) during the treatment period
Platelet Count
achieving a platelet count equal to or greater than 100 x 10 9/L at any time after study day 1 to week 4 (ie, 7 days after the planned third dose of investigational product) and in the absence of platelet transfusions during the preceding 7 days
AEs/SAEs overall safety of romiplostim
Through end of study, up to 36 months

Full Information

First Posted
October 12, 2017
Last Updated
October 12, 2023
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT03362177
Brief Title
Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Gastrointestinal, Pancreatic, or Colorectal Cancer
Acronym
RECITE
Official Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2019 (Actual)
Primary Completion Date
April 29, 2024 (Anticipated)
Study Completion Date
April 29, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-induced Thrombocytopenia
Keywords
Chemotherapy Induced Thrombocytopenia, Gastrointestinal Cancer, Colorectal Cancer, Pancreatic Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
162 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Romiplostim
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Romiplostim
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo Comparator
Primary Outcome Measure Information:
Title
Incidence of a Thrombocytopenia-induced chemotherapy dose modification during the second or third on study chemotherapy cycles.
Description
No thrombocytopenia-induced modification of any myelosuppressive treatment agent in the second and third cycles of the planned on-study chemotherapy regimen. Thrombocytopenia-induced modifications include chemotherapy dose reduction, delay, omission, or chemotherapy treatment discontinuation due to platelet counts below 100 x 10 9/L
Time Frame
48 days
Secondary Outcome Measure Information:
Title
Depth of Platelet Count
Description
the depth of the platelet count nadir from the start of the first on-study chemotherapy cycle through the end of the treatment period
Time Frame
48 days
Title
First platelet response
Description
The time to first platelet response, defined by platelet count ≥ 100 x 109/L in the absence of platelet transfusions during the preceding 7 days
Time Frame
7 Days
Title
Bleeding Events
Description
the duration-adjusted event rate of ≥ grade 2 bleeding events, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grading scale
Time Frame
48 days
Title
Overall Survival
Description
1-year overall survival
Time Frame
1-year
Title
Subject incidence of Platelet Transfusion
Description
platelet transfusion(s) during the treatment period
Time Frame
48 days
Title
Platelet Count
Description
achieving a platelet count equal to or greater than 100 x 10 9/L at any time after study day 1 to week 4 (ie, 7 days after the planned third dose of investigational product) and in the absence of platelet transfusions during the preceding 7 days
Time Frame
7 days
Title
AEs/SAEs overall safety of romiplostim
Description
Through end of study, up to 36 months
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amgen Call Center
Phone
866-572-6436
Email
medinfo@amgen.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Saint Bernards Medical Center
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Individual Site Status
Recruiting
Facility Name
Pacific Cancer Medical Center Inc
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California Irvine
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Name
Colorado West Healthcare System dba Grand Valley Oncology
City
Grand Junction
State/Province
Colorado
ZIP/Postal Code
81505
Country
United States
Individual Site Status
Completed
Facility Name
Mid Florida Hematology and Oncology Centers PA
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Individual Site Status
Recruiting
Facility Name
Oncology and Hematology Associates of West Broward, PA
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Individual Site Status
Recruiting
Facility Name
Cleveland Clinic Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Individual Site Status
Recruiting
Facility Name
Orchard Healthcare Research Inc
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Individual Site Status
Recruiting
Facility Name
Christus Saint Frances Cabrini Hospital
City
Alexandria
State/Province
Louisiana
ZIP/Postal Code
71301
Country
United States
Individual Site Status
Completed
Facility Name
University Medical Center New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Individual Site Status
Terminated
Facility Name
Christus Highland Cancer Treatment Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Individual Site Status
Recruiting
Facility Name
Mercy Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Individual Site Status
Terminated
Facility Name
American Oncology Partners of Maryland, PA
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Individual Site Status
Recruiting
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Name
Hattiesburg Clinic Hematology/Oncology
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Individual Site Status
Terminated
Facility Name
Oncology Hematology Associates
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Individual Site Status
Recruiting
Facility Name
Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Individual Site Status
Completed
Facility Name
Regional Cancer Care Associates
City
Sparta
State/Province
New Jersey
ZIP/Postal Code
78071
Country
United States
Individual Site Status
Terminated
Facility Name
The Center for Cancer and Blood Disorders
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Individual Site Status
Completed
Facility Name
Medical Oncology Associates PS
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States
Individual Site Status
Recruiting
Facility Name
Yakima Valley Memorial Hospital
City
Yakima
State/Province
Washington
ZIP/Postal Code
98902
Country
United States
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Fundacion Favaloro
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1093AAS
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Instituto Oncologico Cordoba
City
Cordoba
State/Province
Córdoba
ZIP/Postal Code
5003
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Centro de Investigaciones Clínicas Clínica Viedma
City
Viedma
State/Province
Río Negro
ZIP/Postal Code
8500
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Centro de Diagnostico Investigacion y Tratamiento
City
Salta
ZIP/Postal Code
4400
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Landeskrankenhaus Steyr
City
Steyr
ZIP/Postal Code
4400
Country
Austria
Individual Site Status
Terminated
Facility Name
Universitaetsklinikum Allgemeines Krankenhaus Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Terminated
Facility Name
Instituto de Oncologia do Parana
City
Curitiba
State/Province
Paraná
ZIP/Postal Code
80530-010
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Vencer e Oncoclinica
City
Teresina
State/Province
Piauí
ZIP/Postal Code
64049-200
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Centro de Pesquisa da Serra Gaucha - Cepesg
City
Caxias do Sul
State/Province
Rio Grande Do Sul
ZIP/Postal Code
95020-450
Country
Brazil
Individual Site Status
Terminated
Facility Name
Catarina Pesquisa Clinica
City
Itajaí
State/Province
Santa Catarina
ZIP/Postal Code
88301-220
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Loema Instituto de Pesquisa Clinica e Consultores Ltda
City
Campinas
State/Province
São Paulo
ZIP/Postal Code
13010-001
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Casa de Saude Santa Marcelina
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
08270-120
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Complex Oncology Center - Ruse EOOD
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Medical Center Nadezhda Clinical EOOD
City
Sofia
ZIP/Postal Code
1330
Country
Bulgaria
Individual Site Status
Completed
Facility Name
Specialized Hospital for Active Treatment of Oncology EAD
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
Individual Site Status
Completed
Facility Name
Cape Breton Cancer Centre, Nova Scotia Health Authority
City
Sydney
State/Province
Nova Scotia
ZIP/Postal Code
B1P 1P3
Country
Canada
Individual Site Status
Recruiting
Facility Name
Grand River Regional Cancer Centre at Grand River Hospital
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2G 1G3
Country
Canada
Individual Site Status
Completed
Facility Name
Fundacion Colombiana de Cancerologia Clinica Vida
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
050030
Country
Colombia
Individual Site Status
Terminated
Facility Name
Oncomedica Imat
City
Monteria
State/Province
Córdoba
ZIP/Postal Code
230002
Country
Colombia
Individual Site Status
Terminated
Facility Name
Centro Medico Imbanaco
City
Cali
State/Province
Valle Del Cauca
ZIP/Postal Code
760042
Country
Colombia
Individual Site Status
Terminated
Facility Name
Centre Hospitalier Universitaire de Brest
City
Brest cedex
ZIP/Postal Code
29609
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Européen Georges Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Foch
City
Suresnes
ZIP/Postal Code
92150
Country
France
Individual Site Status
Recruiting
Facility Name
Institut Gustave Roussy
City
Villejuif Cedex
ZIP/Postal Code
94805
Country
France
Individual Site Status
Recruiting
Facility Name
General Hospital of Athens Laiko
City
Athens
ZIP/Postal Code
11526
Country
Greece
Individual Site Status
Completed
Facility Name
Aretaieio Hospital
City
Athens
ZIP/Postal Code
11528
Country
Greece
Individual Site Status
Recruiting
Facility Name
Evgenidio Hospital I Agia Trias
City
Athens
ZIP/Postal Code
11528
Country
Greece
Individual Site Status
Recruiting
Facility Name
Attikon University Hospital
City
Athens
ZIP/Postal Code
12462
Country
Greece
Individual Site Status
Recruiting
Facility Name
General Oncology Hospital of Kifissia Agioi Anargyroi
City
Athens
ZIP/Postal Code
14564
Country
Greece
Individual Site Status
Recruiting
Facility Name
University Hospital of Patras
City
Patra
ZIP/Postal Code
26504
Country
Greece
Individual Site Status
Recruiting
Facility Name
Agios Loukas Clinic
City
Thessaloniki
ZIP/Postal Code
55236
Country
Greece
Individual Site Status
Recruiting
Facility Name
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Individual Site Status
Terminated
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Terminated
Facility Name
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktatokorhaz
City
Gyor
ZIP/Postal Code
9024
Country
Hungary
Individual Site Status
Terminated
Facility Name
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Individual Site Status
Terminated
Facility Name
Azienda Socio Sanitaria Territoriale di Cremona
City
Cremona
ZIP/Postal Code
26100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
City
Milano
ZIP/Postal Code
20162
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Citta della Salute e della Scienza di Torino Ospedale Molinette
City
Torino
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Completed
Facility Name
Oncotech
City
La Paz
State/Province
Baja California Sur
ZIP/Postal Code
23040
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Centro de Atencion e Investigacion Cardiovascular del Potosi Sc
City
San Luis Potosi
State/Province
San Luis Potosí
ZIP/Postal Code
78200
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Centro Medico Nacional Siglo XXI
City
Mexico
ZIP/Postal Code
06720
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Oaxaca Site Management Organization SC
City
Oaxaca
ZIP/Postal Code
68000
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Hospital Goyeneche
City
Arequipa
ZIP/Postal Code
04001
Country
Peru
Individual Site Status
Terminated
Facility Name
Oncosalud
City
Lima
ZIP/Postal Code
15036
Country
Peru
Individual Site Status
Terminated
Facility Name
Wojewodzki Szpital Specjalistyczny w Bialej Podlaskiej
City
Biala Podlaska
ZIP/Postal Code
21-500
Country
Poland
Individual Site Status
Recruiting
Facility Name
Powiatowe Centrum Zdrowia w Brzezinach Sp Z o o
City
Brzeziny
ZIP/Postal Code
95-060
Country
Poland
Individual Site Status
Recruiting
Facility Name
Uniwersytecki Szpital Kliniczny w Poznaniu
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Individual Site Status
Recruiting
Facility Name
Uniwersytecki Szpital Kliniczny w Poznaniu
City
Poznan
ZIP/Postal Code
60-780
Country
Poland
Individual Site Status
Terminated
Facility Name
Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano
City
Matosinhos
ZIP/Postal Code
4464-513
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Centro Hospitalar Universitario do Porto EPE - Hospital de Santo Antonio
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Individual Site Status
Terminated
Facility Name
Centro Hospitalar Universitario de Sao Joao, EPE - Hospital Sao Joao
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Centro Hospitalar Tras-os-Montes e Alto Douro EPE - Unidade de Vila Real
City
Vila Real
ZIP/Postal Code
5000-508
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Policlinica de Diagnostic Rapid
City
Brasov
ZIP/Postal Code
500152
Country
Romania
Individual Site Status
Terminated
Facility Name
Fundeni Clinical Institute for Digestive Disorders and Liver Transplantation
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Individual Site Status
Recruiting
Facility Name
Spitalul Clinic al Cailor Ferate Cluj Napoca
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
Individual Site Status
Recruiting
Facility Name
SC Medisprof SRL
City
Cluj-Napoca
ZIP/Postal Code
400124
Country
Romania
Individual Site Status
Recruiting
Facility Name
Centrul de Oncologie Sf Nectarie SRL
City
Craiova
ZIP/Postal Code
200347
Country
Romania
Individual Site Status
Terminated
Facility Name
Institutul Regional de Oncologie Iasi
City
Iasi
ZIP/Postal Code
700483
Country
Romania
Individual Site Status
Terminated
Facility Name
SC Oncomed SRL
City
Timisoara
ZIP/Postal Code
300239
Country
Romania
Individual Site Status
Recruiting
Facility Name
SBHI of Arkhangelsk region Arkhangelsk clinical oncology dispensary
City
Arkhangelsk
ZIP/Postal Code
163045
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Autonomic SHI Republican clinical oncology dispensary of MoH of the Republic of Tatarstan
City
Kazan
ZIP/Postal Code
420029
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Medsi Group
City
Moscow Region
ZIP/Postal Code
143442
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Clinical hospital 2, Group of companies medsi
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
LLC Tonus
City
Nizhniy Novgorod
ZIP/Postal Code
603089
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
Omsk Regional Clinical Oncology Dispensary
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
State budget institution of public health Pyatigorsk oncology dispensary
City
Pyatigorsk
ZIP/Postal Code
357502
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
State Institution of Public Health
City
Ryazan
ZIP/Postal Code
390011
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Leningrad Regional Oncology Dispensary na L D Roman
City
Saint Petersburg
ZIP/Postal Code
191104
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
FSBI Scientific and Research Oncology Institute named after N N Petrov
City
Saint-Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
State Institution of Public Health Oncology Dispensary 2 of Public Health Krasnodar Region
City
Sochi
ZIP/Postal Code
354057
Country
Russian Federation
Individual Site Status
Completed
Facility Name
State Institution of Public Health Tambov Regional Oncology Dispensary
City
Tambov
ZIP/Postal Code
390013
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
Respublican clinical oncology dispensary Minzdrava of Republic of Bashkortostan
City
Ufa
ZIP/Postal Code
450054
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Hospital Clinico Universitario San Cecilio
City
Granada
State/Province
Andalucía
ZIP/Postal Code
18016
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinico Universitario de Salamanca
City
Salamanca
State/Province
Castilla León
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Terminated
Facility Name
Hospital Universitario Arnau de Vilanova Lleida
City
Lleida
State/Province
Cataluña
ZIP/Postal Code
25198
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari Sant Joan de Reus
City
Reus
State/Province
Cataluña
ZIP/Postal Code
43204
Country
Spain
Individual Site Status
Recruiting
Facility Name
Complexo Hospitalario Universitario de Ourense
City
Ourense
State/Province
Galicia
ZIP/Postal Code
32005
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Madrid Sanchinarro
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Individual Site Status
Recruiting
Facility Name
Baskent Universitesi Adana Doktor Turgut Noyan Uygulama ve Arastirma Merkezi
City
Adana
ZIP/Postal Code
01250
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Doktor Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
City
Ankara
ZIP/Postal Code
06200
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Hacettepe Universitesi Tip Fakultesi
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi
City
Ankara
ZIP/Postal Code
06560
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ankara Bilkent Sehir Hastanesi
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Individual Site Status
Terminated
Facility Name
Istanbul Universitesi Onkoloji Enstitusu
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Prof Dr Cemil Tascioglu Sehir Hastanesi
City
Istanbul
ZIP/Postal Code
34384
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi
City
Istanbul
ZIP/Postal Code
34722
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ege Universitesi Tip Fakultesi
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Izmir Ekonomi Universitesi Medical Point Hastanesi
City
Izmir
ZIP/Postal Code
35575
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Kocaeli Universitesi Arastirma ve Uygulama Hastanesi
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Individual Site Status
Recruiting
Facility Name
VM Medical Park Samsun Hastanesi
City
Samsun
ZIP/Postal Code
55200
Country
Turkey
Individual Site Status
Terminated
Facility Name
Communal Institution Chernivtsi Regional Clinical Oncological Dispensary
City
Chernivtsi
ZIP/Postal Code
58013
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Prykarpatskyy Clinical Oncology Centre
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Individual Site Status
Terminated
Facility Name
Transcarpathian Regional Clinical Oncological Dispensary
City
Uzhgorod
ZIP/Postal Code
88000
Country
Ukraine
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://www.amgen.com/datasharing
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

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

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