Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as CP-751,871, CP-751, 871
CP-751, 871+ carboplatin+ paclitaxel · 9 trials · 7 indications
The 6 month survival probability was defined as the probability of survival at 6 months based on the Kaplan-Meier estimate. The time was from date of enrollment to date of death due to any cause. For participants who were last known to be alive, overall survival was censored at the last contact date.
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.
A DLT was defined as any one of the following adverse events observed in Cycle 1 which was considered as related to CP-751,871 combination therapy; 1) \>=Grade 3 gastrointestinal toxicity, hyperglycemia and/or fatigue despite the use of adequate/optimal medical intervention, 2) Any other \>=Grade 3 toxicity not classified under CTCAE blood/bone marrow, or 3) Grade 4 neutropenia that persisted for \>=7 consecutive days or was complicated by fever (defined as a body temperature \>38.0 Celsius degree), 4) Grade 3 thrombocytopenia which needed blood transfusion or Grade 4 thrombocytopenia.
Cycle 1 figitumumab attributed: Grade (Gr) 4 neutropenia (absolute neutrophil count \<500 cells/cubic millimeter \[mm\^3\]) \>=7 days, febrile neutropenia (Gr 3, fever \>=38.5 degrees Celsius), neutropenic infection (Gr 3 neutropenia, infection); Gr 4 thrombocytopenia (platelet \<25,000 cells/mm\^3), Gr 3 thrombocytopenia \>=7 days/bleeding; other Gr 3 not blood/bone marrow Common Terminology Criteria for Adverse Events bar gastrointestinal toxicity, treatment-managed hyperglycemia/fatigue, hypersensitivity; Gr 3-4 hyperglycemia despite treatment; fail to adequately recover to continue study treatment
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
The maximum tolerated dose of CP-751,871 in combination with paclitaxel and carboplatin is the highest dose level below the Maximum Administered Dose (the dose level at which 2 or more out of 3 to 6 patients experience a Dose Limiting Toxicity at a dose level in Cycle 1) at which none or one out of 6 patients experience a Cycle 1 Dose Limiting Toxicity.
Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumor (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.
Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumor (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Single arm study |
| 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 | - |
| CP-751,871 | EXPERIMENTAL | - |
| CP-751,871 combined with docetaxel | EXPERIMENTAL | - |
| Phase 2 (Arms A & B) | EXPERIMENTAL | CP-751,871 + paclitaxel + carboplatin |
| Phase 1b | EXPERIMENTAL | 1. Phase 1b Dose Escalation /Expansion: CP-751,871 + paclitaxel + carboplatin 2. Phase 1b Erlotinib Extension: CP-751,871 + paclitaxel + carboplatin + erlotinib |
| Single agent CP-751,871 | EXPERIMENTAL | dose escalation design |
| Name | Type | Description |
|---|---|---|
| CP-751, 871 | BIOLOGICAL | Human IgG2 Monoclonal Antibody. 20mg/kg or 30 mg/kg every 3 weeks for 17 cycles, until progression or unacceptable toxicity develops. |
| 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. |
| CP-751,871 + carboplatin + paclitaxel | DRUG | Chemotherapy (carboplatin and paclitaxel) and CP-751,871 (6, 10 or 20mg/kg) will be administered by intravenous infusion every three weeks. |
| Cisplatin | DRUG | Cisplatin 75\* mg/m2 or 80\* mg/m2, IV on Day 1 of each 21-day cycle up to 6 cycles. \* 75 mg/m2 when in combination with pemetrexed, 80 mg/m2 when in combination with gemcitabine |
| Gemcitabine | DRUG | Gemcitabine 1250 mg/m2, IV on Days 1 and 8 of each 21-day cycle up to 6 cycles |
| Pemetrexed | DRUG | Pemetrexed 500 mg/m2, IV on Day 1 of each 21-day cycle up to 6 cycle |
| paclitaxel | DRUG | Phase 2 Arm A: Paclitaxel 200 mg/m2, IV over 3 hours up to 6 cycles Phase 2 Arm B: Paclitaxel 200 mg/m2, IV over 3 hours up to 6 cycles |
| carboplatin | DRUG | Phase 2 Arm A: Carboplatin AUC 6, IV over 15-60 minutes up to 6 cycles Phase 2 Arm B: Carboplatin AUC 6, IV over 15-60 minutes up to 6 cycles |
| erlotinib | DRUG | Phase 1b Erlotinib Extension: erlotinib 150 mg/day orally every day (up to 17 cycles) |
Inclusion Criteria: * Patients who have stage IV colorectal cancer * Patients whose disease has worsened despite prior anti-cancer therapy * Patients who have satisfactory bonemarrow, kidney and liver function Exclusion Criteria: * Patients who are being simultaneously treated with another anti-c...
CP-751,871 is an investigational small molecule studied in combination with carboplatin and paclitaxel for advanced non-small cell lung cancer. It has also been evaluated in advanced non-hematologic malignancies, multiple myeloma, colorectal neoplasm, Ewing's sarcoma family of tumors, and prostatic neoplasms. It is not an approved therapy and remains in clinical development.
Pfizer, Inc. is the developer of CP-751,871. Pfizer trades on the New York Stock Exchange under the ticker PFE. The company has sponsored Phase 1 studies of the agent in advanced solid tumors and hematologic cancers, including lung cancer and multiple myeloma.
CP-751,871 is in Phase 1 clinical development. Three Phase 1 trials have been completed, with no active trials ongoing. The studies together enrolled 347 participants. The program has not advanced beyond early-stage testing, and the drug is investigational rather than approved.
CP-751,871 has been studied in three completed Phase 1 trials. NCT00603538 tested it with carboplatin and paclitaxel in advanced lung cancer in Japan. NCT00560573 combined it with cisplatin and gemcitabine in chemotherapy-naive advanced non-small cell lung cancer. NCT01536145 evaluated it in multiple myeloma, and NCT01653158 studied it with docetaxel in advanced non-hematologic malignancies.
Yes. CP-751,871, CP-751, 871, and CP-751,871 plus carboplatin plus paclitaxel all refer to the same Pfizer compound and its combination regimen. The variations are formatting differences in how the agent and its chemotherapy partners are written in study records and publications.
In the lung cancer trials, CP-751,871 was given in combination with platinum-based chemotherapy. NCT00603538 paired it with carboplatin and paclitaxel in Japanese patients with advanced non-small cell lung cancer, while NCT00560573 paired it with cisplatin and gemcitabine in chemotherapy-naive patients with advanced non-small cell lung cancer.