Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CP-751, 871+ carboplatin+ paclitaxel · 3 trials · 1 indication
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
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 |
|---|---|---|
| CP-751,871 | EXPERIMENTAL | - |
| 1 | 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 |
| Name | Type | Description |
|---|---|---|
| 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. |
| CP-751,871 | DRUG | CP-751,871 at doses ranging from 6 to 20 mg/Kg on Day 1 of each 21-day cycle. CP-751,871 may be administered even after active comparators discontinuation, for a total number of 17 cycles (1 year). |
| 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: * Diagnosis of advanced non-small cell lung cancer * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Exclusion Criteria: * Any prior treatment for non-small cell lung cancer * Brain metastases * With diabetes
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.