NCT02564094

Brief Summary

This study will evaluate the efficacy, safety, and pharmacoeconomics of treatment with subcutaneous (SC) epoetin beta (NeoRecormon) in participants with hematologic malignancies or solid tumors. The anticipated time on study treatment is 20 weeks, and the target sample size is 60 individuals.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2005

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
9.3 years until next milestone

First Submitted

Initial submission to the registry

September 28, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 30, 2015

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

1.3 years

First QC Date

September 28, 2015

Last Update Submit

November 1, 2016

Conditions

Anemia

Outcome Measures

Primary Outcomes (3)

  • Response rate according to hemoglobin level

    At Week 4

  • Transfusion requirement rate

    From Weeks 5 to 12

  • Predictive value of reticulocyte increase

    At Week 2

Secondary Outcomes (1)

  • Incidence of adverse events (AEs)

    Up to approximately 6 months

Study Arms (1)

Epoetin beta

EXPERIMENTAL

Participants with hematologic or solid malignancies will receive epoetin beta for a treatment period of approximately 20 weeks.

Drug: Epoetin beta

Interventions

Epoetin betaDRUG

Participants will receive SC epoetin beta as 30,000 international units (IU) once weekly for 20 weeks.

Also known as: NeoRecormon
Epoetin beta

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults at least 18 years of age
  • Multiple myeloma (MM), low-grade non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), breast cancer, lung cancer, or ovarian cancer
  • Anemia with low erythropoeitin (EPO) levels

You may not qualify if:

  • Poorly controlled hypertension
  • Relevant acute or chronic bleeding requiring therapy within 3 months before study drug
  • Treatment with EPO within the last 6 weeks
  • Pregnant or breastfeeding females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Unknown Facility

Plovdiv, 4000, Bulgaria

Location

Unknown Facility

Plovdiv, 4004, Bulgaria

Location

Unknown Facility

Sofia, 1527, Bulgaria

Location

Unknown Facility

Sofia, 1756, Bulgaria

Location

Unknown Facility

Sofia, 1757, Bulgaria

Location

Unknown Facility

Sofia, 1784, Bulgaria

Location

Unknown Facility

Stara Zagora, 8000, Bulgaria

Location

Unknown Facility

Varna, 9002, Bulgaria

Location

Unknown Facility

Varna, 9010, Bulgaria

Location

MeSH Terms

Conditions

Anemia

Interventions

epoetin beta

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2015

First Posted

September 30, 2015

Study Start

February 1, 2005

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

BU(9)