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Determination of the effect of balugrastim on the duration and severity of severe neutropenia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pilot Phase: Balugrastim Low Dose | Experimental | Participants will receive balugrastim low dose administered by subcutaneous (SC) injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). |
|
| Pilot Phase: Balugrastim Medium Dose | Experimental | Participants will receive balugrastim medium dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). |
|
| Pilot Phase: Balugrastim High Dose | Experimental | Participants will receive balugrastim high dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). |
|
| Pilot Phase: Pegfilgrastim | Active Comparator | Participants will receive pegfilgrastim 6 mg administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Balugrastim | Biological | Balugrastim (Recombinant Human Albumin-Human Granulocyte Colony Stimulating Factor) will be administered per dose and schedule specified in the arm description. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Severe Neutropenia in Cycle 1 | Severe neutropenia was defined as Grade 4 neutropenia (absolute neutrophil count [ANC] <0.5 x 10^9/liter [L]). The duration of severe neutropenia was calculated by cycle as the number of days from the first day in which the ANC fell below 0.5 x 10^9/L after beginning a chemotherapy cycle until the participant had an ANC ≥0.5 x 10^9/L within the cycle. | Cycle 1 (cycle length = 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Febrile Neutropenia | Febrile neutropenia was defined as an imputed or observed ANC <0.5 x 10^9/L and oral temperature ≥38.2 degrees celsius (°C) occurring on the same day. Number of participants with febrile neutropenia over all cycles (Cycles 1 to 4) has been reported. | Cycles 1 to 4 (each cycle length = 21 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Teva Medical Expert, MD | Teva Branded Pharmaceutical Products R&D, Inc. | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pilot Phase: Balugrastim Low Dose | Participants received balugrastim low dose administered by subcutaneous (SC) injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). |
| FG001 | Pilot Phase: Balugrastim Medium Dose | Participants received balugrastim medium dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). |
| FG002 | Pilot Phase: Balugrastim High Dose | Participants received balugrastim high dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). |
| FG003 | Pilot Phase: Pegfilgrastim | Participants received pegfilgrastim 6 mg, administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). |
| FG004 | Main Phase: Balugrastim Medium Dose | Participants received balugrastim medium dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). |
| FG005 | Main Phase: Balugrastim High Dose | Participants received balugrastim high dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). |
| FG006 | Main Phase: Pegfilgrastim | Participants received pegfilgrastim 6 mg, administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pilot Phase |
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| |||||||||||||||||||||
| Main Phase |
|
Modified intent-to-treat (mITT) population included all participants who were randomized into the study and received at least 1 dose of assigned study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pilot Phase: Balugrastim Low Dose | Participants received balugrastim low dose administered by subcutaneous (SC) injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). |
| BG001 | Pilot Phase: Balugrastim Medium Dose |
| 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 | Duration of Severe Neutropenia in Cycle 1 | Severe neutropenia was defined as Grade 4 neutropenia (absolute neutrophil count [ANC] <0.5 x 10^9/liter [L]). The duration of severe neutropenia was calculated by cycle as the number of days from the first day in which the ANC fell below 0.5 x 10^9/L after beginning a chemotherapy cycle until the participant had an ANC ≥0.5 x 10^9/L within the cycle. | mITT population included all participants who were randomized into the study and received at least 1 dose of assigned study drug. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | days | Cycle 1 (cycle length = 21 days) |
|
From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
mITT population included all participants who were randomized into the study and received at least 1 dose of assigned study drug. Per planned analysis, adverse events are reported combined for pilot and main phase.
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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 | Balugrastim Low Dose | Participants received balugrastim low dose administered by subcutaneous (SC) injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Research | Teva Branded Pharmaceutical Products R&D, Inc. | 1-888-483-8279 | USMedInfo@tevapharm.com |
| ID | Term |
|---|---|
| C000600093 | balugrastim |
| C455861 | pegfilgrastim |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Main Phase: Balugrastim Medium Dose | Experimental | Participants will receive balugrastim medium dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). |
|
| Main Phase: Balugrastim High Dose | Experimental | Participants will receive balugrastim high dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). |
|
| Main Phase: Pegfilgrastim | Active Comparator | Participants will receive pegfilgrastim 6 mg administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). |
|
|
| Pegfilgrastim | Drug | Pegfilgrastim will be administered per dose and schedule specified in the arm description. |
|
| Chemotherapy Regimen | Drug | The chemotherapy regimen consisting of doxorubicin 60 mg/square meter (m^2) and docetaxel 75 mg/m^2 will be administered sequentially by intravenous (IV) infusion on Day 1 of treatment for up to four 21-day cycles. |
|
| Duration of Severe Neutropenia in Cycles 2, 3, and 4 | Severe neutropenia was defined as Grade 4 neutropenia (ANC <0.5 x 10^9/L). The duration of severe neutropenia was calculated by cycle as the number of days from the first day in which the ANC fell below 0.5 x 10^9/L after beginning a chemotherapy cycle until the participant had an ANC ≥0.5 x 10^9/L within the cycle. | Cycles 2, 3, and 4 (each cycle length = 21 days) |
| Time to Absolute Neutrophil Count (ANC) Recovery in Cycles 1, 2, 3, and 4 | Time to ANC recovery was defined as the time from the nadir ANC to an ANC ≥1.5 x 10^9/L and was calculated for participants with ANC <1.5 x 10^9/L after the beginning of a chemotherapy cycle. Time to ANC recovery was calculated by cycle as the number of days from the nadir (the lowest ANC during a chemotherapy cycle) until a participant reached an ANC >1.5 x 10^9/L. | Cycles 1, 2, 3, and 4 |
| Decision of the investigator |
|
| Adverse Event |
|
| Disease progression |
|
| Participant left the city |
|
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
Participants received balugrastim medium dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). |
| BG002 | Pilot Phase: Balugrastim High Dose | Participants received balugrastim high dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). |
| BG003 | Pilot Phase: Pegfilgrastim | Participants received pegfilgrastim 6 mg, administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). |
| BG004 | Main Phase: Balugrastim Medium Dose | Participants received balugrastim medium dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). |
| BG005 | Main Phase: Balugrastim High Dose | Participants received balugrastim high dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). |
| BG006 | Main Phase: Pegfilgrastim | Participants received pegfilgrastim 6 mg, administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). |
| BG007 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | Pilot Phase: Balugrastim Medium Dose | Participants received balugrastim medium dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). |
| OG002 | Pilot Phase: Balugrastim High Dose | Participants received balugrastim high dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). |
| OG003 | Pilot Phase: Pegfilgrastim | Participants received pegfilgrastim 6 mg, administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). |
| OG004 | Main Phase: Balugrastim Medium Dose | Participants received balugrastim medium dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). |
| OG005 | Main Phase: Balugrastim High Dose | Participants received balugrastim high dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). |
| OG006 | Main Phase: Pegfilgrastim | Participants received pegfilgrastim 6 mg, administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). |
|
|
| Secondary | Number of Participants With Febrile Neutropenia | Febrile neutropenia was defined as an imputed or observed ANC <0.5 x 10^9/L and oral temperature ≥38.2 degrees celsius (°C) occurring on the same day. Number of participants with febrile neutropenia over all cycles (Cycles 1 to 4) has been reported. | mITT population included all participants who were randomized into the study and received at least 1 dose of assigned study drug. | Posted | Count of Participants | Participants | Cycles 1 to 4 (each cycle length = 21 days) |
|
|
|
| Secondary | Duration of Severe Neutropenia in Cycles 2, 3, and 4 | Severe neutropenia was defined as Grade 4 neutropenia (ANC <0.5 x 10^9/L). The duration of severe neutropenia was calculated by cycle as the number of days from the first day in which the ANC fell below 0.5 x 10^9/L after beginning a chemotherapy cycle until the participant had an ANC ≥0.5 x 10^9/L within the cycle. | mITT population included all participants who were randomized into the study and received at least 1 dose of assigned study drug. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified cycle. | Posted | Mean | Standard Deviation | days | Cycles 2, 3, and 4 (each cycle length = 21 days) |
|
|
|
| Secondary | Time to Absolute Neutrophil Count (ANC) Recovery in Cycles 1, 2, 3, and 4 | Time to ANC recovery was defined as the time from the nadir ANC to an ANC ≥1.5 x 10^9/L and was calculated for participants with ANC <1.5 x 10^9/L after the beginning of a chemotherapy cycle. Time to ANC recovery was calculated by cycle as the number of days from the nadir (the lowest ANC during a chemotherapy cycle) until a participant reached an ANC >1.5 x 10^9/L. | mITT population included all participants who were randomized into the study and received at least 1 dose of assigned study drug. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified cycle. | Posted | Mean | Standard Deviation | days | Cycles 1, 2, 3, and 4 |
|
|
|
| 3 |
| 10 |
| 9 |
| 10 |
| EG001 | Balugrastim Medium Dose | Participants received balugrastim medium dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). | 11 | 105 | 102 | 105 |
| EG002 | Balugrastim High Dose | Participants received balugrastim high dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). | 9 | 104 | 100 | 104 |
| EG003 | Pegfilgrastim | Participants received pegfilgrastim 6 mg, administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). | 10 | 112 | 105 | 112 |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 11.1 | Systematic Assessment |
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| Abdominal wall abscess | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Diabetic foot | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
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| Soft tissue necrosis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
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| Cyclothymic disorder | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
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| Calculus ureteric | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
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| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Granulocytopenia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
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| Leukocytosis | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
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| Lymphopenia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
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| Neutrophilia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
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| Cardiomyopathy | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
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| Ventricular extrasystoles | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA 11.1 | Systematic Assessment |
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| Lacrimation increased | Eye disorders | MedDRA 11.1 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 11.1 | Systematic Assessment |
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| Chest discomfort | General disorders | MedDRA 11.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 11.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 11.1 | Systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 11.1 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 11.1 | Systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA 11.1 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
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| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
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Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
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| Cycle 3 |
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| Cycle 4 |
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| Cycle 2 |
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| Cycle 3 |
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| Cycle 4 |
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