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

  • STATUS
    Recruiting
  • End date
    Jan 1, 2024
  • participants needed
    162
  • sponsor
    Amgen
Updated on 22 October 2021
Investigator
Amgen Call Center
Primary Contact
Research Site (1.5 mi away) Contact
+196 other location

Summary

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

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

Details
Condition Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia, Chemotherapy-induced Thrombocytopenia
Treatment Placebo, romiplostim
Clinical Study IdentifierNCT03362177
SponsorAmgen
Last Modified on22 October 2021

Eligibility

Yes No Not Sure

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 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, 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. 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 platelet count < 75 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 central laboratory assessment at screening
Known active chronic hepatitis B or C infection. Subjects without a documented diagnosis in their medical history will require a central laboratory assessment at screening. 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 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 central laboratory during screening
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 central laboratory during screening
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
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