NCT02767765

Brief Summary

This study will evaluate the efficacy and tolerability of subcutaneous (SC) or intramuscular (IM) recombinant human erythropoietin beta (r-HuEPO) in participants with anemia and histologically or cytologically confirmed cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2003

Typical duration for phase_3

Geographic Reach
1 country

7 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

June 1, 2003

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
9.6 years until next milestone

First Submitted

Initial submission to the registry

May 6, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 10, 2016

Completed
11 months until next milestone

Results Posted

Study results publicly available

April 4, 2017

Completed
Last Updated

April 4, 2017

Status Verified

February 1, 2017

Enrollment Period

3.3 years

First QC Date

May 6, 2016

Results QC Date

February 16, 2017

Last Update Submit

February 16, 2017

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Response to Treatment

    Response to treatment was defined as an increase of greater than (\>) 1 gram per deciliter (g/dL) in hemoglobin level (irrespective of the need of transfusion) from Baseline value at Week 4.

    Week 4

Secondary Outcomes (5)

  • Time to Response

    Baseline up to Week 4

  • Percentage of Participants With Response to Treatment After 2 Weeks of Study Treatment

    Week 2

  • Percentage of Participants With No Response to Treatment After 4 Weeks of Study Treatment

    Week 4

  • Percentage of Participants Who Required Transfusion

    Baseline, Week 2, Week 4

  • Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Questionnaire Score at Week 4

    Baseline, Week 4

Study Arms (1)

r-HuEPO

EXPERIMENTAL

Anemic cancer participants will receive r-HuEPO for 4 weeks.

Drug: r-HuEPO

Interventions

r-HuEPODRUG

All participants will receive r-HuEPO for 4 weeks, at a dose of 10000 international units per day (IU/day) according to 6 days/week schedule for first 2 weeks and at a dose of 10000 IU/day according to 3 days/week schedule (participants with response to treatment at end of Week 2) or according to 6 days/week schedule (participants without response to treatment at end of Week 2) for next 2 weeks.

Also known as: NeoRecormon
r-HuEPO

Eligibility Criteria

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

You may qualify if:

  • Histological or cytological confirmed cancer
  • Participants who are treated with at least first line chemotherapy
  • Hemoglobin less than (\<) 11 grams per deciliter (g/dL)
  • Participants able to receive iron supplement, if necessary

You may not qualify if:

  • History of hypersensitivity to active or inactive excipients of r-HuEPO
  • Insufficient controllable hypertension
  • Thalassemic syndromes
  • Anemia caused by hematic loss
  • Women who are pregnant or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Unknown Facility

Bari, 70124, Italy

Location

Unknown Facility

Benevento, 82100, Italy

Location

Unknown Facility

Cagliari, 09124, Italy

Location

Unknown Facility

Campobasso, 86100, Italy

Location

Unknown Facility

Napoli, 80131, Italy

Location

Unknown Facility

Palermo, 90127, Italy

Location

Unknown Facility

Palermo, 90146, Italy

Location

MeSH Terms

Conditions

Anemia

Interventions

Erythropoietinepoetin beta

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Results Point of Contact

Title
Medical Communications
Organization
Hoffmann-La Roche
genentech@druginfo.com
800-821-8590

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2016

First Posted

May 10, 2016

Study Start

June 1, 2003

Primary Completion

October 1, 2006

Study Completion

October 1, 2006

Last Updated

April 4, 2017

Results First Posted

April 4, 2017

Record last verified: 2017-02

Locations

IT(7)