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Also known as IV Chemotherapy (Regimen 1), Chemotherapy
Standard Chemotherapy · 1 trial · 8 indications
Grade 3/4 febrile neutropenia (FN) is defined as: • A temperature ≥ 38.0°C (≥ 100.4°F) and absolute neutrophil count (ANC) \< 1.0 × 10\^9/L, where ANC was measured the same day or within ± 1 calendar day of a temperature ≥ 38.0°C (≥ 100.4°F), or • An ANC \< 1.0 × 10\^9/L in combination with: - documented sepsis or infection, OR - neutropenia-related hospitalization where ANC was measured the same day or within ± 1 calendar day. Participants monitored their oral temperatures and maintained diaries to record their temperature twice per day: once in the morning and once in the evening, as well as whenever they suspect they had fever throughout the first 4 cycles of chemotherapy treatment.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2, and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus placebo subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4). |
| Pegfilgrastim | PLACEBO_COMPARATOR | Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2 and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus pegfilgrastim 6 mg administered as a single subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4). |
| Name | Type | Description |
|---|---|---|
| Pegfilgrastim | DRUG | Administered as a single 6 mg subcutaneous injection using a pre-filled syringe. There will be no dosage adjustments for investigational product. |
| Placebo | DRUG | Administered as a single subcutaneous injection using a pre-filled syringe. |
| Bevacizumab | BIOLOGICAL | 5 mg/kg by intravenous (IV) infusion on day 1 of each 14-day cycle. |
| Standard Chemotherapy | DRUG | Each participant received one of the following chemotherapy regimens at the discretion of treating physician: FOLFOX: Oxaliplatin, leucovorin, and 5-fluorouracil; FOLFIRI: Irinotecan, leucovorin and 5-flurouracil. |
Inclusion Criteria: Disease-related: * Histologically or cytologically-confirmed adenocarcinoma of the colon or rectum * Locally-advanced or metastatic disease by radiographic evaluation * Measurable disease * Has not previously received chemotherapy for locally-advanced or metastatic colorectal c...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520/ GEH200521- Part A |
| Zimmer Biomet Holdings, Inc. | ZBH | 1 | - | Undisclosed |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |
Maintenance Chemotherapy is used for cancer, including metastatic colorectal cancer. It is an investigational small molecule therapy being studied as a maintenance treatment after initial induction therapy for patients with metastatic colorectal cancer. The drug is in Phase 2 clinical development.
Maintenance Chemotherapy is developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker AMGN. Amgen is conducting clinical trials to evaluate the drug's safety and efficacy in patients with metastatic colorectal cancer.
Maintenance Chemotherapy is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for the maintenance treatment of metastatic colorectal cancer following induction therapy.
Maintenance Chemotherapy has been studied in clinical trial NCT01991873, a Phase 2 trial titled 'Maintenance Therapy With 5-FU/FA Plus Panitumumab vs. 5-FU/FA Alone After Prior Induction and Re-induction After Progress for 1st-line Treatment of Metastatic Colorectal Cancer.' This trial enrolled 387 patients in Germany and has been completed.
Yes, Maintenance Chemotherapy is also known as IV Chemotherapy (Regimen 1) and Chemotherapy. These alternative names refer to the same drug being developed by Amgen Inc. for the treatment of metastatic colorectal cancer.