A Study of Epoetin Beta (NeoRecormon) in Participants With Solid Tumors

An Open-Label Study of the Safety Of NeoRecormon in Patients With Solid Tumors Being Treated With Platinum Capable of Inducing Anemia

Sponsors

Lead Sponsor: Hoffmann-La Roche

Source Hoffmann-La Roche
Brief Summary

This study will evaluate the safety of subcutaneous (SC) epoetin beta (NeoRecormon) in adults with solid tumors being treated with platinum-based chemotherapy capable of inducing anemia. The anticipated time on study treatment is 16 weeks, and the target sample size is approximately 208 individuals.

Overall Status Completed
Start Date June 2004
Completion Date September 2005
Primary Completion Date September 2005
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Incidence of adverse events Up to 16 weeks
Secondary Outcome
Measure Time Frame
Hemoglobin response rate index Up to 16 weeks
Enrollment 28
Condition
Intervention

Intervention Type: Drug

Intervention Name: Epoetin beta

Description: Participants will receive weekly SC injections of epoetin beta beginning at 450 IU/kg, with doses adjusted according to hemoglobin level. Treatment will continue for a total of 16 weeks.

Arm Group Label: Epoetin beta

Other Name: NeoRecormon

Eligibility

Criteria:

Inclusion Criteria:

- Adults at least 18 years of age

- Presence of solid tumor(s)

- Receiving platinum-based therapy capable of inducing anemia

Exclusion Criteria:

- Red blood cell transfusion within 7 days prior to study drug

- Relevant acute or chronic bleeding requiring therapy within 3 months prior to study drug

- Women who are pregnant or breastfeeding

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Clinical Trials Study Chair Hoffmann-La Roche
Location
Facility:
| Alcoy, 03804, Spain
| Barakaldo, 48903, Spain
| Barcelona, 08036, Spain
| Barcelona, 08041, Spain
| Barcelona, 08916, Spain
| Caceres, 10003, Spain
| El Palmar Murcia, 30120, Spain
| La Laguna, 38320, Spain
| Manresa, 08243, Spain
| Salamanca, 37007, Spain
| Valencia, 46010, Spain
| Valencia, 46026, Spain
| Zaragoza, 50009, Spain
Location Countries

Spain

Verification Date

November 2016

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Epoetin beta

Type: Experimental

Description: Participants will receive weekly SC injection of epoetin beta (450 international units per kilogram [IU/kg]) for 16 weeks.

Study Design Info

Allocation: Non-Randomized

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov