Determination of the effect of neugranin on the duration and severity of severe neutropenia in participants receiving doxorubicin in combination with docetaxel.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
381
Neugranin will be administered per dose and schedule specified in the arm description.
Pegfilgrastim will be administered per dose and schedule specified in the arm description.
The chemotherapy regimen for this trial consists of doxorubicin 60 mg/m\^2 and docetaxel 75 mg/m\^2 in combination
Double-Blind Phase: 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.
Time frame: Cycle 1 (cycle length = 21 days)
Open-Label Phase: Duration of Severe Neutropenia in Cycle 1
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. There was no planned statistical analysis for the open-label phase arm.
Time frame: Cycle 1 (cycle length = 21 days)
Double-Blind Phase: Number of Participants With Febrile Neutropenia
Febrile neutropenia was defined as an imputed or observed ANC \<0.5 x 10\^9/L and body temperature \>38.5 degrees celsius (°C) occurring on the same day and for more than one hour (axillary measurement). Number of participants with febrile neutropenia over all cycles (Cycles 1 to 4) has been reported.
Time frame: Cycles 1-4 (each cycle = 21 days)
Open-Label Phase: Number of Participants With Febrile Neutropenia
Febrile neutropenia was defined as an imputed or observed ANC \<0.5 x 10\^9/L and body temperature \>38.5 °C occurring on the same day and for more than one hour (axillary measurement). Number of participants with febrile neutropenia over all cycles (Cycles 1 to 4) has been reported.
Time frame: Cycles 1-4 (each cycle = 21 days)
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Teva Investigational Site 3502
Gabrovo, Bulgaria
Teva Investigational Site 3511
Plovdiv, Bulgaria
Teva Investigational Site 3504
Rousse, Bulgaria
Teva Investigational Site 3501
Shumen, Bulgaria
Teva Investigational Site 3506
Sofia District, Bulgaria
Teva Investigational Site 3503
Stara Zagora, Bulgaria
Teva Investigational Site 3505
Varna, Bulgaria
Teva Investigational Site 3507
Veliko Tarnovo, Bulgaria
Teva Investigational Site 4001
Baia Mare, Maramures County, Romania
Teva Investigational Site 4009
Brasov, Romania
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