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Balugrastim · 1 trial · 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.
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| Balugrastim | BIOLOGICAL | Balugrastim (Recombinant Human Albumin-Human Granulocyte Colony Stimulating Factor) will be administered per dose and schedule specified in the arm description. |
| 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. |
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 an investigational monoclonal antibody being developed for chemotherapy-induced neutropenia, a condition of low white blood cell counts caused by cancer treatment. It is studied in patients with breast cancer receiving chemotherapy. Balugrastim is in Phase 2 clinical development and is not yet approved.
Balugrastim is being developed by Teva Pharmaceutical Industries Limited, traded on the stock exchange under the ticker TEVA. The company is conducting clinical research on this investigational drug for chemotherapy-induced neutropenia.
Balugrastim is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. One Phase 2 clinical trial has been completed, and the drug remains under study for chemotherapy-induced neutropenia.
Balugrastim has one completed clinical trial, NCT00837265, titled "Balugrastim (Neugranin) in Breast Cancer Participants Receiving Doxorubicin/Docetaxel." This Phase 2 study enrolled 334 participants with chemotherapy-induced neutropenia. The trial was active-controlled and randomized, but not double-blind.
Yes, Balugrastim is also known as Neugranin. The clinical trial NCT00837265 refers to the drug as "Balugrastim (Neugranin)," indicating that Neugranin is an alternative name for the same investigational drug being developed for chemotherapy-induced neutropenia.