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Also known as Neugranin
Balugrastim · 2 trials · 1 indication
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| Double-Blind Phase: Pegfilgrastim | ACTIVE_COMPARATOR | Participants will receive pegfilgrastim 6 milligrams (mg), 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). The chemotherapy regimen consists of doxorubicin 60 mg/square meter (m\^2) and docetaxel 75 mg/m\^2 administered sequentially by intravenous (IV) infusion on Day 1 of treatment for up to four 21-day cycles. |
| Double-Blind Phase: Neugranin 40 mg | EXPERIMENTAL | Participants will receive neugranin 40 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). The chemotherapy regimen consists of doxorubicin 60 mg/m\^2 and docetaxel 75 mg/m\^2 administered sequentially by IV infusion on Day 1 of treatment for up to four 21-day cycles. |
| Open-Label Phase: Neugranin 40 mg | EXPERIMENTAL | Participants will receive neugranin 40 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). The chemotherapy regimen consists of doxorubicin 60 mg/m\^2 and docetaxel 75 mg/m\^2 administered sequentially by IV infusion on Day 1 of treatment for up to four 21-day cycles. |
| 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). |
| 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). |
| Name | Type | Description |
|---|---|---|
| Neugranin | BIOLOGICAL | Neugranin will be administered per dose and schedule specified in the arm description. |
| Pegfilgrastim | BIOLOGICAL | Pegfilgrastim will be administered per dose and schedule specified in the arm description. |
| Chemotherapy | DRUG | The chemotherapy regimen for this trial consists of doxorubicin 60 mg/m\^2 and docetaxel 75 mg/m\^2 in combination |
| Balugrastim | BIOLOGICAL | Balugrastim (Recombinant Human Albumin-Human Granulocyte Colony Stimulating Factor) 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. |
Inclusion Criteria: * Breast cancer participants scheduled to receive the AT regimen (doxorubicin/ docetaxel) Exclusion Criteria: * Participants may have received no more than 1 prior chemotherapy regimen (including adjuvant therapy if given within the last 12 months)
Balugrastim is being developed for chemotherapy-induced neutropenia, a drop in neutrophil counts that can follow cancer chemotherapy. It has been studied in breast cancer participants receiving doxorubicin and docetaxel. It is an investigational agent and is not approved for commercial use.
Balugrastim targets CSF3R, the colony stimulating factor 3 receptor, and acts as an agonist at that receptor. By activating CSF3R signaling, it is designed to stimulate neutrophil production, which is the rationale for its development in chemotherapy-induced neutropenia.
Balugrastim is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva is the sponsor associated with the clinical program for this agent in chemotherapy-induced neutropenia.
Balugrastim is in Phase 2 development. It is an investigational monoclonal antibody and has not been approved by the FDA. The clinical program includes one completed Phase 2 trial, and no trials are currently active.
Balugrastim has been evaluated in the completed Phase 2 trial NCT00837265, titled Balugrastim (Neugranin) in Breast Cancer Participants Receiving Doxorubicin/Docetaxel. That trial enrolled 334 participants, was randomized and active-controlled, and studied chemotherapy-induced neutropenia.
Yes, Neugranin is an alternative name for Balugrastim. The completed Phase 2 trial NCT00837265 refers to the agent as Balugrastim (Neugranin), so searches for either name point to the same investigational drug being developed by Teva for chemotherapy-induced neutropenia.