A Safety Study of Epoetin Alfa in Patients With Cancer Who Have Chemotherapy-Related Anemia

NCT01394991 | Completed Phase 4 Results

• 2 other identifiers: CR010543EPOANE4008
• Study Type: interventional
• Target: 504
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study is to evaluate the safety of epoetin alfa in patients with cancer who have chemotherapy-related anemia.

Conditions

Anemia; Neoplasms

Keywords

Epoetin alfa (EPREX, ERYPO)

Outcome Measures

Primary Outcomes (1)

• Number of Participants With at Least 1 Clinically Relevant and Objectively Confirmed Thrombovascular Event From Randomization Through Week 16

  Clinically relevant and objectively confirmed thrombovascular event (TVE) was determined by the Adjudication Committee from randomization through Week 16. Clinically relevant TVEs were defined as deep vein thrombosis (DVT) of the limbs; thromboses of other major veins; pulmonary embolism (PE);acute coronary syndrome (ACS);ischemic stroke of arterial or cardiac origin; cerebral venous thrombosis; and arterial thrombosis. Objectively confirmed was defined as the confirmation of the clinical diagnosis of a TVE by appropriate medical imaging studies and laboratory tests.

  from randomization through Week 16

Secondary Outcomes (7)

• Number of Positively Adjudicated Thrombovascular Events

  during the study (randomization through week 26)

• Time to First Positively Adjudicated Thrombovascular Event

  during the study (randomization through week 26)

• Number of Suspected Thrombovascular Events

  during the study (randomization through week 26)

• Time to First Suspected Thrombovascular Event

  during the study (randomization through week 26)

• Mortality

  during the study (randomization through week 26)

Study Arms (2)

001

EXPERIMENTAL

Epoetin alfa 450 IU/kg once a week (QW) 450 IU/kg once a week (QW) by subcutaneous injection preferably in the abdomen for up to 4 weeks after the last dose of chemotherapy for a maximum of 26 weeks

Drug: Epoetin alfa 450 IU/kg once a week; Drug: Epoetin alfa 450 IU/kg once a week (QW)

002

EXPERIMENTAL

Epoetin alfa 150 IU/kg 3 times a week (TIW) 150 IU/kg 3 times a week (TIW) by subcutaneous injection preferably in the abdomen for up to 4 weeks after the last dose of chemotherapy for a maximum of 26 weeks.

Drug: Epoetin alfa 150 IU/kg 3 times a week; Drug: Epoetin alfa 150 IU/kg 3 times a week (TIW)

Interventions

Epoetin alfa 450 IU/kg once a week DRUG

450 IU/kg once a week by subcutaneous injection preferably in the abdomen for up to 4 weeks after the last dose of chemotherapy for a maximum of 26 weeks.

001

Epoetin alfa 150 IU/kg 3 times a week DRUG

150 IU/kg 3 times a week by subcutaneous injection preferably in the abdomen for up to 4 weeks after the last dose of chemotherapy for a maximum of 26 weeks.

002

Epoetin alfa 450 IU/kg once a week (QW) DRUG

450 IU/kg once a week (QW) by subcutaneous injection preferably in the abdomen for up to 4 weeks after the last dose of chemotherapy for a maximum of 26 weeks

001

Epoetin alfa 150 IU/kg 3 times a week (TIW) DRUG

150 IU/kg 3 times a week (TIW) by subcutaneous injection preferably in the abdomen for up to 4 weeks after the last dose of chemotherapy for a maximum of 26 weeks.

002

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any nonmyeloid tumor confirmed by cytology and/or histology
• Day 1 baseline hemoglobin (Hb) level \<=11 g/dL
• Expected to receive at least 12 weeks of chemotherapy after enrollment into the study
• Eastern Cooperative Oncology Group (ECOG) performance status \<= 2

You may not qualify if:

• History of active second cancer except for adequately treated skin cancer and in situ (pre-invasive) cervical cancer
• History of deep venous thrombosis (DVT) (blood clots in the veins of the thighs or legs) or pulmonary embolism (PE) (blood clot in the lungs) 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
• History of cardiovascular accident (CVA), transient ischemic attack (TIA) (stroke), acute coronary syndrome (ACS) (a condition indicating damage to the heart), or other arterial thrombosis (blood clots) within 6 months before study entry
• Onset of seizures within 3 months before randomization or poorly controlled seizures
• Brain tumor or brain metastasis from another malignancy or cardiac disease that is markedly or completely limiting, uncontrolled hypertension (high blood pressure), or anemia (a lack of red blood cells in the blood) for reasons other than cancer or chemotherapy
• Specifically excluded concomitant medications or therapies including prophylactic anticoagulation therapy for recurrence of prior thrombovascular event (TVE) (warfarin, unfractionated heparin, low molecular weight heparin \[LMWH\], except for prevention of central venous catheter thrombosis at doses specified in the protocol, direct thrombin inhibitors, or anti-platelet drugs \[e.g., clopidogrel or ticlopidine\]), except for prophylaxis in patients with known cardiovascular disease

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

MeSH Terms

Conditions

Anemia; Neoplasms

Interventions

Epoetin Alfa

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Clinical Development Team Lead
• Organization: Johnson and Johnson PRD

1 908 218 6097

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 10, 2010
• First Posted: July 15, 2011
• Study Start: January 1, 2006
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: April 5, 2012
• Results First Posted: July 15, 2011

Record last verified: 2012-04