Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CP-751, 871 · 5 trials · 5 indications
Percentage of participants with PSA best response of either PSA normalization (PN) or partial PSA response (PR) relative to the total number of participants evaluable for response. PN was defined as PSA =\< 0.2 nanogram/milliliter (ng/ml) on 2 successive evaluations at least 3 weeks apart and no imaging or clinical evidence of disease progression. PP was defined as \>= 50% decrease in PSA from baseline on 2 successive evaluations at least 3 weeks apart and no imaging or clinical evidence of disease progression.
Percentage of participants with objective response based on assessment of confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target and non-target disease and no new lesions. PR was defined as ≥30% decrease under baseline of the sum of diameters of all target lesions.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 150 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Area under the plasma concentration versus time curve (AUC) from time zero to 25 hours post dose, the nominal time of the last sample (24 hours after end of infusion)
Area under the plasma concentration versus time curve (AUC) from time zero to 25 hours post dose, the nominal time of the last sample (24 hours after end of infusion)
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) divided by dose
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) divided by dose
Maximum Observed Plasma Concentration (Cmax) divided by dose
Maximum Observed Plasma Concentration (Cmax) divided by dose
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | For patients treated with docetaxel and prednisone only, who progress during treatment, CP-751,871 will be added to the regimen to test reversibility of chemoresistance. |
| B | ACTIVE_COMPARATOR | - |
| 1 | EXPERIMENTAL | - |
| CP-751,871 combined with docetaxel | EXPERIMENTAL | - |
| Single agent CP-751,871 | EXPERIMENTAL | dose escalation design |
| Name | Type | Description |
|---|---|---|
| CP-751,871 | DRUG | CP-750,871 is administered intravenously at a dose of 20 mg/kg on day 1 of each 21-day cycle (for patient convenience and logistical management, the dose of CP-751,871 may be deferred up to 7 days). |
| docetaxel | DRUG | Docetaxel is administered IV on day 1 of each 21-day cycle, at a dose of 75 mg/m2. |
| prednisone | DRUG | Prednisone is administered at a dose of 5 mg twice daily. |
Inclusion Criteria: * Diagnosis of metastatic, progressive hormone refractory prostate cancer * Adequate bone marrow, liver and kidney function Exclusion Criteria: * Previous treatment with chemotherapy
CP-751,871 is an investigational monoclonal antibody being studied in oncology for several cancers, including prostate cancer, non-small-cell lung cancer, colorectal neoplasms, multiple myeloma, Ewing's sarcoma family of tumors, and advanced non-hematologic malignancies. It is being developed by Pfizer, Inc. (NYSE: PFE).
CP-751,871 targets the insulin-like growth factor 1 receptor (IGF-1R), as indicated by its study title 'Anti-IGF-IR CP-751,871'. By binding to this receptor, the antibody is designed to interfere with cancer cell growth signaling pathways.
CP-751,871 is developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. Pfizer is conducting clinical trials of this investigational drug in multiple oncology indications.
CP-751,871 is in Phase 2 clinical development. It has completed three trials, including a Phase 2 study in prostate cancer and Phase 1 studies in other solid tumors. It is not FDA approved and remains investigational.
CP-751,871 has completed three clinical trials: NCT00313781 (Phase 2, prostate cancer, 204 patients), NCT00474760 (Phase 1, Ewing's sarcoma, 65 patients), and NCT00603538 (Phase 1, non-small-cell lung cancer, 19 patients). All trials are completed with no active studies.
CP-751,871 is also known as figitumumab, a name used in some clinical literature. This investigational monoclonal antibody targeting IGF-1R has been studied under both names in Pfizer's oncology trials.