Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
monoclonal antibody · 1 trial · 1 indication
Any of the following during first cycle of treatment and attributable to CP-870893: afebrile Grade (Gr) 4 neutropenia (absolute neutrophil count \[ANC\] \<500 cells/mm\^3) ≥7 days or Gr 3 or 4 neutropenia associated with fever (1 oral temperature \>38.5 degrees Celsius (C) or 3 oral temperatures \>38.0 degrees C in a 24-hour period); Gr 4 thrombocytopenia or Gr 3 thrombocytopenia associated with bleeding; Gr 4 lymphopenia, if coupled with clinical consequence (such as, opportunistic infection) or any other Gr 3 hematological adverse events; ≥Gr 3 non-hematologic toxicities (except alopecia).
| Arm | Type | Description |
|---|---|---|
| single arm | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| monoclonal antibody | BIOLOGICAL | CP-870,893 intravenous administration \[IV\] on day 3 of 4-week cycles |
| chemotherapy | DRUG | gemcitabine 1000 mg/m\^2 intravenous administration \[IV\] q week \[wk\]x3 of 4-week cycles |
Inclusion Criteria: * 1st-line surgically incurable cancer of the pancreas * ECOG(Eastern Cooperative Oncology Group) performance status 0-1 Exclusion Criteria: * Previous systemic therapy for pancreas cancer * History of cancer-associated blood clots * History of autoimmune disease
The monoclonal antibody is an investigational immunostimulant antibody being studied for the treatment of advanced cancer of the pancreas, specifically pancreatic neoplasm. It is being evaluated in combination with chemotherapy in a clinical trial setting. The drug is still in clinical development and has not been approved for this indication.
Roche Holding AG (ticker: RHHBY) is developing the monoclonal antibody. The company is conducting clinical research on this investigational immunostimulant antibody for the treatment of pancreatic neoplasm. The drug is currently in Phase 1 clinical development.
The monoclonal antibody is in Phase 1 clinical development. It is an investigational drug being studied for pancreatic neoplasm. The Phase 1 trial has been completed, and the drug remains in early-stage clinical development. It is not yet approved by regulatory authorities.
The monoclonal antibody is associated with one completed clinical trial, NCT00711191, titled "A Study On An Immunostimulant Antibody In Combination With Chemotherapy For Advanced Cancer Of The Pancreas." This Phase 1 trial enrolled 22 participants in the United States and evaluated the drug in combination with chemotherapy for pancreatic neoplasm.
The monoclonal antibody is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for pancreatic neoplasm. The completed Phase 1 trial, NCT00711191, was an early-stage study, and the drug has not yet received regulatory approval for any indication.