STUDY OF ROMIPLOSTIM FOR CHEMOTHERAPY-INDUCED THROMBOCYTOPENIA IN ADULT SUBJECTS WITH GASTROINTESTINAL OR COLORECTAL CANCER.

Not Applicable

Recruiting

Conditions: -D695 Secondary thrombocytopenia
Secondary thrombocytopenia
D695

Registration Number: PER-027-19

Lead Sponsor: AMGEN INC.,

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 0

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 or colorectal adenocarcinoma, defined as cancers of the esophagus, stomach, colon, or rectum. Tumor stage will not affect eligibility.
-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.
-Subjects must have a platelet count < 75 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.
-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 Class III to IV), symptomatic ischemia, uncontrolled arrhythmias, clinically significant electrocardiogram (ECG)
abnormalities, screening ECG with corrected QT 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 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.
-In addition to Acute lymphoblastic leukemia and Multiple myeloma, 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 Acute lymphoblastic leukemia and Multiple myeloma).
-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 investigationa

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:A 2-sided CMH test will be used to compare<br>groups controlling for the stratification factors of tumor type and baseline platelet<br>count. The Mantel-Haenszel estimate of common odds ratio for romiplostim vs placebo<br>will be estimated along with a 95% CI for each treatment group and the difference in<br>proportions between treatment groups will be provided with a 95% CI.<br><br>Measure:Primary endpoint, which is no thrombocytopenia-induced modification of any myelosuppressive treatment agent.<br>Chemotherapy dose modification includes dose reduction, delay, omission, and discontinuation.<br><br>Timepoints:second and third cycles of the planned on-study chemotherapy regimen.<br>

Secondary Outcome Measures