Anemia
Conditions
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.
Interventions
DRUGr-HuEPO
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.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Response to Treatment | Week 4 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Response | Baseline up to Week 4 | Time to response was defined as the time between the start of treatment and the increase in hemoglobin level \>1 g/dL compared to baseline hemoglobin level. Time to response was estimated using Kaplan Meier method. |
| Percentage of Participants With Response to Treatment After 2 Weeks of Study Treatment | Week 2 | Response to treatment after 2 weeks of treatment was defined as presence of any of the following criteria: reticulocytes \>40000 per microliter or \>25% increase in soluble transferrin receptor or \>0.5 g/dL increase in hemoglobin level. |
| Percentage of Participants With No Response to Treatment After 4 Weeks of Study Treatment | Week 4 | No Response to treatment after 4 weeks was defined as meeting any of the following criteria: \<1 g/dL increase in hemoglobin level or hemoglobin level \<8.5 g/dL or need of transfusion. If a participant had an increase in hemoglobin level of \>1 g/dL but required transfusion then the participant is considered as Non- Responder. |
| 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 | FACT-An comprises of 4 subscales of 27-item (FACT-General scale \[FACT-G\]): physical well-being, social/family well-being, emotion well-being, functional well-being, and an additional concerns anemia subscale. All questions are rated on a scale from 0 to 4, where higher scores indicate more impact on quality of life. The physical well-being subscale consists of 7 questions with score range from 0-28; social/family well-being subscale consists of 7 questions with score range from 0-28; emotion well-being subscale consists of 6 questions with score range from 0-24; functional well-being subscale consists of 7 questions with score range from 0-28; anemia subscale consist of 20 questions with score range from 0-80. Total FACT-An score ranges from 0-188. |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| r-HuEPO Anemic cancer participants received r-HuEPO as SC or IM injection for 4 weeks, at a dose of 10000 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. | 61 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 4 |
| Overall Study | Death | 1 |
| Overall Study | Insufficient response | 1 |
| Overall Study | Investigator decision | 1 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Non-Compliance | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | r-HuEPO |
|---|---|
| Age, Continuous | 61.31 years STANDARD_DEVIATION 13.55 |
| Sex: Female, Male Female | 32 Participants |
| Sex: Female, Male Male | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 12 / 61 |
| serious Total, serious adverse events | 3 / 61 |
Outcome results
Primary
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.
Time frame: Week 4
Population: The intent-to-treat (ITT) analysis population included all enrolled participants who received study medication for at least 2 weeks.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| r-HuEPO | Percentage of Participants With Response to Treatment | 50.8 percentage of participants |
Secondary
Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Questionnaire Score at Week 4
FACT-An comprises of 4 subscales of 27-item (FACT-General scale \[FACT-G\]): physical well-being, social/family well-being, emotion well-being, functional well-being, and an additional concerns anemia subscale. All questions are rated on a scale from 0 to 4, where higher scores indicate more impact on quality of life. The physical well-being subscale consists of 7 questions with score range from 0-28; social/family well-being subscale consists of 7 questions with score range from 0-28; emotion well-being subscale consists of 6 questions with score range from 0-24; functional well-being subscale consists of 7 questions with score range from 0-28; anemia subscale consist of 20 questions with score range from 0-80. Total FACT-An score ranges from 0-188.
Time frame: Baseline, Week 4
Population: All enrolled participants who completed the questionnaire at baseline were included in the analysis. Here, n represents number of participants evaluable for the specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| r-HuEPO | Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Questionnaire Score at Week 4 | Baseline (n=56) | 23.59 units on a scale | Standard Deviation 10.8 |
| r-HuEPO | Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Questionnaire Score at Week 4 | Change at Week 4 (n=35) | -6.23 units on a scale | Standard Deviation 8.11 |
Secondary
Percentage of Participants Who Required Transfusion
Time frame: Baseline, Week 2, Week 4
Population: ITT analysis population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| r-HuEPO | Percentage of Participants Who Required Transfusion | Baseline | 8.2 percentage of participants |
| r-HuEPO | Percentage of Participants Who Required Transfusion | Week 2 | 4.9 percentage of participants |
| r-HuEPO | Percentage of Participants Who Required Transfusion | Week 4 | 1.7 percentage of participants |
Secondary
Percentage of Participants With No Response to Treatment After 4 Weeks of Study Treatment
No Response to treatment after 4 weeks was defined as meeting any of the following criteria: \<1 g/dL increase in hemoglobin level or hemoglobin level \<8.5 g/dL or need of transfusion. If a participant had an increase in hemoglobin level of \>1 g/dL but required transfusion then the participant is considered as Non- Responder.
Time frame: Week 4
Population: ITT analysis population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| r-HuEPO | Percentage of Participants With No Response to Treatment After 4 Weeks of Study Treatment | 50.8 percentage of participants |
Secondary
Percentage of Participants With Response to Treatment After 2 Weeks of Study Treatment
Response to treatment after 2 weeks of treatment was defined as presence of any of the following criteria: reticulocytes \>40000 per microliter or \>25% increase in soluble transferrin receptor or \>0.5 g/dL increase in hemoglobin level.
Time frame: Week 2
Population: ITT analysis population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| r-HuEPO | Percentage of Participants With Response to Treatment After 2 Weeks of Study Treatment | 78.7 percentage of participants |
Secondary
Time to Response
Time to response was defined as the time between the start of treatment and the increase in hemoglobin level \>1 g/dL compared to baseline hemoglobin level. Time to response was estimated using Kaplan Meier method.
Time frame: Baseline up to Week 4
Population: ITT analysis population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| r-HuEPO | Time to Response | 19 days |