An Observational Study of NeoRecormon (Epoetin Beta) in Anemic Patients With Non-myeloid Malignancy

NCT01716559 | Completed Results

• 1 other identifier: ML25362
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 6

Brief Summary

This observational, prospective, multicenter study will evaluate the treatment response rate and the safety of NeoRecormon (epoetin beta) in anemic patients with non-myeloid malignancy. In addition to NeoRecormon, patients receive chemotherapy for their malignancy. Data will be collected for 16 weeks.

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With an Increase of Greater Than or Equal to 1 Gram Per Decilitre in Hemoglobin Level at Week 8

  Therapeutic response was defined as an increase of greater than or equal to (\>=) 1 gram per decilitre (g/dL) in hemoglobin (Hb) level as compared to baseline, following 8 weeks of Epoetin beta treatment. The Therapeutic response rate was summarized as percentage of participants with an increase of \>= 1 g/dL in Hb level at Week 8 as compared to baseline.

  Baseline to Week 8

Secondary Outcomes (4)

• Mean Change From Baseline in Hemoglobin Level up to Week 16

  Baseline, Week 4, Week 8, Week 12, and Week 16

• Percentage of Red Blood Cell Transfusion-free Participants

  Up to Week 16

• Number of Participants With or With no Response on Efficacy of Treatment With or Without Iron Replacement Therapy

  Up to Week 16

• Number of Participants With Adverse Events and Serious Adverse Events

  Up to Week 16

Study Arms (1)

Cohort

Eligibility Criteria

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

Study Population

Anemic patients with non-myeloid malignancy

You may qualify if:

• Adult patients, \>/=18 years of age
• Presence of solid-tumor or non-myeloid malignancy
• Patients receiving chemotherapy
• Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
• Patients require NeoRecormon

You may not qualify if:

• Hypersensitivity to the drug
• Uncontrolled hypertension
• Female patients if pregnant and/or lactating

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (6)

Unknown Facility

Budapest, 1088, Hungary

Location

Unknown Facility

Budapest, 1125, Hungary

Location

Unknown Facility

Budapest, 1441, Hungary

Location

Unknown Facility

Budapest, 1529, Hungary

Location

Unknown Facility

Kaposvár, 7400, Hungary

Location

Unknown Facility

Szolnok, 5000, Hungary

Location

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Roche Trial Information Hotline
• Organization: F. Hoffmann-La Roche AG

global.trial_information@roche.com

+41 61 6878333

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2012
• First Posted: October 30, 2012
• Study Start: August 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: August 18, 2016
• Results First Posted: February 9, 2016

Record last verified: 2016-08

Locations

HU (6)