Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Blood and Lymph Conditions

Rare Diseases

Breast Neoplasms

Neutropenia

Agranulocytosis

Leukopenia

Cytopenia

Hematologic Diseases

Leukocyte Disorders

Granulocytopenia

Antineoplastic Agents

All Drugs and Chemicals

Doxorubicin

Liposomal doxorubicin

Docetaxel

Lenograstim

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).

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).

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).

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).

Balugrastim (Recombinant Human Albumin-Human Granulocyte Colony Stimulating Factor) will be administered per dose and schedule specified in the arm description.

Balugrastim

Pegfilgrastim will be administered per dose and schedule specified in the arm description.

Pegfilgrastim

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.

Chemotherapy Regimen

Teva Medical Expert, MD

Determination of the effect of balugrastim on the duration and severity of severe neutropenia.

Balugrastim (Neugranin) in Breast Cancer Participants Receiving Doxorubicin/Docetaxel

A Randomized Study of Subcutaneously Administered Neugranin (Recombinant Human Albumin-Human Granulocyte Colony Stimulating Factor) or Pegfilgrastim in Subjects With Breast Cancer Receiving Myelosuppressive Chemotherapy (Doxorubicin/Docetaxel)

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.

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.

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.

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.

Teva Branded Pharmaceutical Products R&D, Inc.

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.

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).

Balugrastim Low 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).

Balugrastim Medium 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).

Balugrastim High Dose

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).

Pilot Phase: Balugrastim Low Dose

Pilot Phase: Balugrastim Medium Dose

Pilot Phase: Balugrastim High Dose

Pilot Phase: Pegfilgrastim

Main Phase: Balugrastim Medium Dose

Main Phase: Balugrastim High Dose

Main Phase: Pegfilgrastim

Total

Age, Continuous

Sex: Female, Male

Race

Race/Ethnicity, Customized

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.

Director, Clinical Research

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.

Duration of Severe Neutropenia in Cycle 1

mITT population included all participants who were randomized into the study and received at least 1 dose of assigned study drug.

Number of Participants With Febrile Neutropenia

Cycle 2

Cycle 3

Cycle 4

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.

Duration of Severe Neutropenia in Cycles 2, 3, and 4

Cycle 1

Time to Absolute Neutrophil Count (ANC) Recovery in Cycles 1, 2, 3, and 4

Pilot Phase

Main Phase

Adjuvants, Immunologic

Immunologic Factors

Balugrastim 300 μg/kg subcutaneously (SC) administration once per chemotherapy cycle, approximately 24 h after chemotherapy, up to 4 cycles

Balugrastim 670 μg/kg (maximum 40 mg) SC administration once per chemotherapy cycle, approximately 24 h after chemotherapy, up to 4 cycles

Filgrastim will be administered at a dose of 5 μg/kg SC once a day for at least 5 consecutive days or until absolute neutrophil count (ANC) has returned to ≥2\*10\^9/L for each chemotherapy cycle up to 4 cycles. The maximum period of filgrastim administration is 14 days in each cycle.

Balugrastim 300 ug/kg and Balugrastim 670 ug/kg

Filgrastim

The primary objective of this study is to find the optimal dose of balugrastim by characterizing its pharmacokinetics (PK), and by comparing the pharmacodynamics (PD) of balugrastim to filgrastim in children receiving chemotherapy.

Pharmacodynamics, Pharmacokinetics, Efficacy and Safety of Balugrastim in Pediatric Patients With Solid Tumors

An Open Label, Randomized, Active Controlled, Dose Finding Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Efficacy and Safety of Balugrastim at Doses of 300 µg/kg and 670 µg/kg in Pediatric Patients Diagnosed With Solid Tumors Receiving Chemotherapy

ANC nadir (measured in 10\^9/L), which is the lowest ANC recorded

Time to ANC nadir, which is the time from the beginning of chemotherapy up to the occurrence of the ANC nadir

Time to ANC recovery (ANC \>1.5\*10\^9/L) from nadir within each treatment cycle

Number of days subject experiences severe neutropenia (ANC \<0.5\*10\^9/L)

Proportion of subjects who experience severe neutropenia (ANC \<0.5\*10\^9/L)

Frequency of febrile neutropenia (defined as body temperature \>38.5°C for more than one hour \[axillary measurement\] and ANC \<0.5\*10\^9/L) by cycle and across all cycles.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Balugrastim (Neugranin) in Breast Cancer Participants Receiving Doxorubicin/Docetaxel	NCT00837265	Chemotherapy-in...	Balugrastim Pegfilgrastim Chemotherapy Re...	18 Years -	Teva Branded Pharmaceutical Products R&D, Inc.
Pharmacodynamics, Pharmacokinetics, Efficacy and Safety of Balugrastim in Pediatric Patients With Solid Tumors	NCT01940601	Solid Tumors	Balugrastim Filgrastim	2 Years - 17 Years	Teva Branded Pharmaceutical Products R&D, Inc.
Pharmacodynamics, Pharmacokinetics, Efficacy and Safety of Balugrastim in Pediatric Patients With Solid Tumors	NCT01940601	Solid Tumors	Balugrastim Filgrastim	2 Years - 17 Years	Teva Branded Pharmaceutical Products R&D, Inc.
Pharmacodynamics, Pharmacokinetics, Efficacy and Safety of Balugrastim in Pediatric Patients With Solid Tumors	NCT01940601	Solid Tumors	Balugrastim Filgrastim	2 Years - 17 Years	Teva Branded Pharmaceutical Products R&D, Inc.

Spots Global Cancer Trial Database for balugrastim

Every month we try and update this database with for balugrastim cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for balugrastim

Every month we try and update this database with for balugrastim cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for balugrastim cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.