Trial Outcomes & Findings for A Study of Recombinant Human Erythropoietin Beta (NeoRecormon) in Anemic Cancer Participants Treated With Chemotherapy (NCT NCT02767765)
NCT ID: NCT02767765
Last Updated: 2017-04-04
Results Overview
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.
COMPLETED
PHASE3
61 participants
Week 4
2017-04-04
Participant Flow
Participant milestones
| Measure |
Recombinant Human Erythropoietin Beta (r-HuEPO)
Anemic cancer participants received r-HuEPO (NeoRecormon) as subcutaneous (SC) or intramuscular (IM) injection 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.
|
|---|---|
|
Overall Study
STARTED
|
61
|
|
Overall Study
COMPLETED
|
50
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Recombinant Human Erythropoietin Beta (r-HuEPO)
Anemic cancer participants received r-HuEPO (NeoRecormon) as subcutaneous (SC) or intramuscular (IM) injection 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.
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|---|---|
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Overall Study
Adverse Event
|
4
|
|
Overall Study
Death
|
1
|
|
Overall Study
Insufficient response
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Investigator decision
|
1
|
|
Overall Study
Non-Compliance
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
A Study of Recombinant Human Erythropoietin Beta (NeoRecormon) in Anemic Cancer Participants Treated With Chemotherapy
Baseline characteristics by cohort
| Measure |
r-HuEPO
n=61 Participants
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.
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|---|---|
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Age, Continuous
|
61.31 years
STANDARD_DEVIATION 13.55 • n=99 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=99 Participants
|
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Sex: Female, Male
Male
|
29 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Week 4Population: The intent-to-treat (ITT) analysis population included all enrolled participants who received study medication for at least 2 weeks.
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.
Outcome measures
| Measure |
r-HuEPO
n=61 Participants
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.
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|---|---|
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Percentage of Participants With Response to Treatment
|
50.8 percentage of participants
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SECONDARY outcome
Timeframe: Baseline up to Week 4Population: ITT analysis population
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.
Outcome measures
| Measure |
r-HuEPO
n=61 Participants
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.
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|---|---|
|
Time to Response
|
19 days
Interval 15.0 to 36.0
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SECONDARY outcome
Timeframe: Week 2Population: ITT analysis population
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.
Outcome measures
| Measure |
r-HuEPO
n=61 Participants
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.
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|---|---|
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Percentage of Participants With Response to Treatment After 2 Weeks of Study Treatment
|
78.7 percentage of participants
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SECONDARY outcome
Timeframe: Week 4Population: ITT analysis population
"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.
Outcome measures
| Measure |
r-HuEPO
n=61 Participants
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.
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|---|---|
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Percentage of Participants With No Response to Treatment After 4 Weeks of Study Treatment
|
50.8 percentage of participants
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SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4Population: ITT analysis population
Outcome measures
| Measure |
r-HuEPO
n=61 Participants
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.
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|---|---|
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Percentage of Participants Who Required Transfusion
Baseline
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8.2 percentage of participants
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Percentage of Participants Who Required Transfusion
Week 2
|
4.9 percentage of participants
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Percentage of Participants Who Required Transfusion
Week 4
|
1.7 percentage of participants
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SECONDARY outcome
Timeframe: Baseline, Week 4Population: 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.
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.
Outcome measures
| Measure |
r-HuEPO
n=56 Participants
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.
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|---|---|
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Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Questionnaire Score at Week 4
Baseline (n=56)
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23.59 units on a scale
Standard Deviation 10.80
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Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Questionnaire Score at Week 4
Change at Week 4 (n=35)
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-6.23 units on a scale
Standard Deviation 8.11
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Adverse Events
r-HuEPO
Serious adverse events
| Measure |
r-HuEPO
n=61 participants at risk
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.
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|---|---|
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Metabolism and nutrition disorders
Cachexia
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1.6%
1/61 • Baseline up to Week 4
Safety population
|
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma recurrent
|
1.6%
1/61 • Baseline up to Week 4
Safety population
|
|
Nervous system disorders
Presyncope
|
1.6%
1/61 • Baseline up to Week 4
Safety population
|
Other adverse events
| Measure |
r-HuEPO
n=61 participants at risk
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.
|
|---|---|
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Blood and lymphatic system disorders
Anaemia
|
3.3%
2/61 • Baseline up to Week 4
Safety population
|
|
Gastrointestinal disorders
Abdominal pain
|
1.6%
1/61 • Baseline up to Week 4
Safety population
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
1.6%
1/61 • Baseline up to Week 4
Safety population
|
|
General disorders
Asthenia
|
1.6%
1/61 • Baseline up to Week 4
Safety population
|
|
General disorders
Oedema peripheral
|
1.6%
1/61 • Baseline up to Week 4
Safety population
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
1.6%
1/61 • Baseline up to Week 4
Safety population
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
1.6%
1/61 • Baseline up to Week 4
Safety population
|
|
Injury, poisoning and procedural complications
Contusion
|
1.6%
1/61 • Baseline up to Week 4
Safety population
|
|
Investigations
Blood bilirubin increased
|
1.6%
1/61 • Baseline up to Week 4
Safety population
|
|
Investigations
Blood creatinine increased
|
1.6%
1/61 • Baseline up to Week 4
Safety population
|
|
Investigations
Blood urea increased
|
1.6%
1/61 • Baseline up to Week 4
Safety population
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.6%
1/61 • Baseline up to Week 4
Safety population
|
|
Investigations
Platelet count decreased
|
1.6%
1/61 • Baseline up to Week 4
Safety population
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.6%
1/61 • Baseline up to Week 4
Safety population
|
|
Metabolism and nutrition disorders
Iron deficiency
|
1.6%
1/61 • Baseline up to Week 4
Safety population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm recurrence
|
1.6%
1/61 • Baseline up to Week 4
Safety population
|
|
Nervous system disorders
Presyncope
|
1.6%
1/61 • Baseline up to Week 4
Safety population
|
|
Reproductive system and breast disorders
Metrorrhagia
|
1.6%
1/61 • Baseline up to Week 4
Safety population
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.6%
1/61 • Baseline up to Week 4
Safety population
|
|
Vascular disorders
Phlebitis
|
1.6%
1/61 • Baseline up to Week 4
Safety population
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER