A Study of Epoetin Beta (NeoRecormon) in Participants Wit... | NCT02564094

Studies
A Study of Epoetin Beta (NeoRecormon) in Participants With Solid Tumors or Hematologic Malignancies

NCT02564094

Sponsor

Hoffmann-La Roche

Status

Completed

Last Update Posted

Nov 2, 2016Estimated

Enrollment

54Actual

Phase

Phase 4

Conditions

Anemia

Interventions

Epoetin beta

Countries

Bulgaria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2005

Primary Completion Date

Jun 2006Actual

Completion Date

Jun 2006Actual

First Submitted Date

Sep 28, 2015

First Submission Date that Met QC Criteria

Sep 28, 2015

First Posted Date

Sep 30, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 1, 2016

Last Update Posted Date

Nov 2, 2016Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

54Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Epoetin beta	Drug	Participants will receive SC epoetin beta as 30,000 international units (IU) once weekly for 20 weeks.	Epoetin beta

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Incidence of adverse events (AEs)		Up to approximately 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Chair

Condition Browse Module

MeSH Terms

ID	Term
D000740	Anemia

Ancestor Terms

ID	Term
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C103998	epoetin beta

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Plovdiv		4000	Bulgaria