EUCTR2006-000914-19-GB
Active, not recruiting
Phase 1
A randomized, open-label, multicenter study evaluating thrombovascular events in subjects with cancer receiving chemotherapy and administered epoetin alfa once or three times a week for the treatment of anemia.
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Janssen-Cilag International N.V.
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Men or women, 18 years of age or older
- •Any histologically confirmed nonmyeloid tumor at initial diagnosis
- •Day 1 baseline Hb d11 g/dL
- •Expected to receive at least 12 weeks of chemotherapy after enrollment
- •into the study. For subjects receiving cyclic chemotherapy,
- •randomization must be on the first day of a chemotherapy cycle. For
- •subjects receiving non\-cyclic chemotherapy, randomization may occur at
- •any time during the chemotherapy.
- •ECOG performance status d2 (Attachment 3\)
- •Life expectancy of \>6 months, based on the clinical judgment of the
Exclusion Criteria
- •History of active second cancer except for adequately treated skin cancer
- •and in situ cervical cancer
- •History of DVT or PE within 12 months before study entry or at any
- •time if the event is related to the current cancer, which is defined as
- •diagnosis of the cancer within 3 months of a DVT/PE episode or a
- •DVT/PE following the cancer diagnosis/treatment. Prior superficial
- •thrombophlebitis is not an exclusion criterion.
- •History of CVA, TIA, ACS, or other arterial thrombosis within 6 months
- •before study entry. ACS includes unstable angina, QwMI, and NQMI
- •Onset of seizures within 3 months before randomization or poorly
Outcomes
Primary Outcomes
Not specified
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