gastrointestinal or colorectal adenocarcinoma, which includes cancers of the esophagus, stomach, colon, or rectum. MedDRA version: 21.0 Level: PT Classification code 10052360 Term: Colorectal adenocarcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: PT Classification code 10053548 Term: Gastrointestinal cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and
Conditions
Interventions
Trade Name: Nplate
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: ROMIPLOSTIM
CAS Number: 267639-76-9
Other descriptive name: ROMIPLOSTIM
Concentration unit: µg/ml microgr
Sponsors
Amgen Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 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. 2. Males or females = 18 years of age at signing of the informed consent. 3. Histologically or cytologically confirmed diagnosis of gastrointestinal or colorectal adenocarcinoma, defined as cancers of the esophagus, stomach, colon, or rectum. Tumor stage will not affect eligibility. 4. Subjects must be receiving a FOLFOX-based chemotherapy regimen, containing 5-FU and oxaliplatin, on a 14-day schedule. Note: Use of a FOLFOX-based combination regimen is permitted with (1) anti-angiogenic agents (such as bevacizumab) or (2) targeted therapy (such as anti-epidermal growth factor receptor agents). FOLFOXIRI-based regimens will not be allowed. 5. Subjects must have a platelet count =65 years) yes F.1.3.1 Number of subjects for this age range 52
Exclusion criteria
Exclusion criteria: 1.Acute lymphoblastic leukemia. 2.Acute myeloid leukemia. 3.Any myeloid malignancy. 4.Myelodysplastic syndrome. 5.Myeloproliferative disease. 6.Multiple myeloma. 7.Within 4 months prior to enrollment, any history of active congestive heart failure 8.Major surgery = 28 days or minor surgery = 3 days prior to enrollment. 9.New or uncontrolled venous thromboembolism or thrombotic events within 3 months prior to screening. 10.History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months of screening. 11.Evidence of active infection within 2 weeks prior to first dose of study treatment. 12.Known human immunodeficiency virus infection. 13.Known active chronic hepatitis B or C infection. 14.In addition to the conditions listed in exclusion criteria 1 through 6, 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 (excluding malignancies listed in exclusion criteria 1 – 6). 15.Thrombocytopenia due to another etiology other than CIT (eg, chronic liver disease, prior history of immune thrombocytopenia purpura). Prior/Concomitant Therapy 16.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 17.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 18.Anemia (hemoglobin 3X ULN; alanine aminotransferase [ALT] or aspartate aminotransferase [AST] > 3X ULN for subjects without liver metastases or = 5X ULN for subjects with liver metastases) Other Exclusions 22.Females who are pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 30 days after treatment discontinuation or longer if required by prescribing information for chemotherapy received during the study. (Females of childbearing potential should only be included after a confirmed menstrual period and a negative highly sensitive urine pregnancy test.) 23. Females of childbearing potential unwilling to use an acceptable method of effective contraception (this will also be dependent on contraceptive requirements for chemotherapy received during the study) during treatment and for an additional 30 days after treatment discontinuation or longer if required by prescribing information for chemotherapy received during the study. Refer t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of romiplostim for the treatment of chemotherapy-induced thrombocytopenia (CIT) in patients receiving chemotherapy for the treatment of gastrointestinal or colorectal cancer, measured by the ability to administer on-time, full-dose chemotherapy;Secondary Objective: - to compare the treatment effect of romiplostim with that of placebo on the depth of platelet nadir - to compare the treatment effect of romiplostim with that of placebo on the time to first platelet response - to compare the treatment effect of romiplostim with that of placebo on the incidence of = grade 2 bleeding events -to compare the treatment effect of romiplostim with that of placebo on overall survival - to compare the treatment effect of romiplostim with that of placebo on the incidence of platelet transfusions -to compare the treatment effect of romiplostim with that of placebo on the proportion of patients achieving platelet response -overall safety of romiplostim;Primary end point(s): 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 109/L;Timepoint(s) of evaluation of this end point: The primary analysis will be performed at the primary completion date. The primary completion date is defined as the date when the last subject is assessed or receives an intervention for the final collection of data for the primary endpoint for the purposes of conducting the primary analysis, whether the study concluded as planned in the protocol or was terminated early. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • the depth of the platelet count nadir from the start of the first on-study chemotherapy cycle through the end of the treatment period • 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 • the duration-adjusted event rate of = grade 2 bleeding events, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 grading scale • overall survival • platelet transfusion(s) during the treatment period • achieving a platelet count = 100 x 109/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 • adverse events, including treatment-emergent adverse events, fatal adverse events, serious adverse events, and clinically significant changes in laboratory values. • anti-romiplostim antibodies and antibodies to thrombopoietin (TPO) • myelodysplastic syndromes and secondary malignancies;Timepoint(s) of evaluation of this end point: -The primary analysis will be performed at the primary completion date. The primary completion date is defined as the date when the last subject is assessed or receives an intervention for the final collection of data for the primary endpoint for the purposes of conducting the primary analysis, whether the study concluded as planned in the protocol or was terminated early. -When the last subject in the trial completes LTFU at 1 year after the last dose of investigational product, the final database will be locked and unblinded for the final analysis. In the final analysis, the secondary endpoints assessment, and all the exploratory endpoints will be evaluated | — |
Countries
Argentina, Austria, Brazil, Bulgaria, Canada, Chile, Colombia, France, Greece, Hungary, Italy, Mexico, Peru, Poland, Portugal, Romania, Russian Federation, Spain, Ukraine, United States
Contacts
Public ContactMedical Information
Amgen Hellas ?.?.?.
Outcome results
None listed