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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| r-HuEPO | Experimental | Anemic cancer participants will receive r-HuEPO for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| r-HuEPO | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline up to Week 4 |
| Percentage of Participants With Response to Treatment After 2 Weeks of Study Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bari | 70124 | Italy | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The safety population included all enrolled participants who received at least one dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The intent-to-treat (ITT) analysis population included all enrolled participants who received study medication for at least 2 weeks. | Posted | Number | percentage of participants | Week 4 |
|
Baseline up to Week 4
Safety population
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cachexia | Metabolism and nutrition disorders | MedDRA v18.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v18.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| C103998 | epoetin beta |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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|
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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. |
| Week 2 |
| 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. | 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 | 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. | Baseline, Week 4 |
| Benevento |
| 82100 |
| Italy |
| Cagliari | 09124 | Italy |
| Campobasso | 86100 | Italy |
| Naples | 80131 | Italy |
| Palermo | 90127 | Italy |
| Palermo | 90146 | Italy |
| Lost to Follow-up |
|
| Investigator decision |
|
| Non-Compliance |
|
| Withdrawal by Subject |
|
| years |
|
| Sex: Female, Male | Count of Participants | 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. | ITT analysis population | Posted | Median | 95% Confidence Interval | days | Baseline up to Week 4 |
|
|
|
| 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. | ITT analysis population | Posted | Number | percentage of participants | Week 2 |
|
|
|
| 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. | ITT analysis population | Posted | Number | percentage of participants | Week 4 |
|
|
|
| Secondary | Percentage of Participants Who Required Transfusion | ITT analysis population | Posted | Number | percentage of participants | Baseline, Week 2, Week 4 |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 4 |
|
|
|
| 3 |
| 61 |
| 12 |
| 61 |
| Pancreatic carcinoma recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v18.1 | Non-systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA v18.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA v18.1 | Non-systematic Assessment |
|
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA v18.1 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA v18.1 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA v18.1 | Non-systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA v18.1 | Non-systematic Assessment |
|
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA v18.1 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA v18.1 | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA v18.1 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA v18.1 | Non-systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA v18.1 | Non-systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA v18.1 | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA v18.1 | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA v18.1 | Non-systematic Assessment |
|
| Iron deficiency | Metabolism and nutrition disorders | MedDRA v18.1 | Non-systematic Assessment |
|
| Neoplasm recurrence | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v18.1 | Non-systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA v18.1 | Non-systematic Assessment |
|
| Metrorrhagia | Reproductive system and breast disorders | MedDRA v18.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA v18.1 | Non-systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA v18.1 | Non-systematic Assessment |
|
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.
| D016298 |
| Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| Title | Measurements |
|---|
|