Phase 1
Completed N=46
Study Of CP-751,871 In Combination With Cisplatin And Gemcitabine In Chemotherapy-Naïve Patients With Advanced Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov NCT00560573 ↗Enrolled (actual)
46
Serious AEs
55.6%
Results posted
Feb 2013
Primary outcomePrimary: Number of Participants With Dose-limiting Toxicities (DLT) — 0; 0; 1 participants
Summary
CP 751,871 is a fully human monoclonal antibody against the Insulin-Like Growth Factor 1 Receptor (IGF-1R). Preclinical and clinical data indicate that CP 751,871 augments the anti-tumor activity of chemotherapy. This study will identify the Maximal Tolerated Dose of CP 751,871 (or the Maximal Feasible Dose) in combination with standard gemcitabine-cisplatin chemotherapy for the treatment of advanced Non-Small Cell Lung cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Dose-limiting Toxicities (DLT) |
0; 0; 1 | — |
| SECONDARY Concentration at the End of Infusion (Cinf) for Figitumumab |
120.4; 137.0; 435.0; 513.4 | — |
| SECONDARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Figitumumab |
26020; 21500; 84100; 121200 | — |
| SECONDARY Minimum Observed Plasma Trough Concentration (Cmin) for Figitumumab |
113.6 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) for Cisplatin |
3.816; 3.880; 2.845; 3.490 | — |
| SECONDARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Cisplatin |
38.23; 45.18; 37.12; 48.29 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) for Gemcitabine |
12.85; 23.97 | — |
| SECONDARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Gemcitabine |
6.665; 12.53 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) for Pemetrexed |
72.96; 93.13 | — |
| SECONDARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Pemetrexed |
132.2; 161.6 | — |
| SECONDARY Percentage of Participants With Objective Response or Prolonged Stabilization |
53.3; 56.5; 46.2 | — |
| SECONDARY Progression-Free Survival (PFS) |
5.7; 6.5; 5.4 | — |
| SECONDARY Duration of Response (DR) |
— | — |
| SECONDARY Percentage of Participants With Blood Anti-drug Antibody (ADA) Specific for Figitumumab |
50.0; 33.3; 50.0; 80.0; 100; 100 | — |
| SECONDARY Serum Total Circulating Insulin-like Growth Factor (IGF-1) Levels |
124.88; 543.63 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically proven diagnosis of Stage IIIB (N3 and/or T4) or Stage IV Non-Small Cell Lung Cancer in patients 18-year-old or older, with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 not amenable to curative surgery or radiation therapy and an adequate organ function (bone marrow, hepatic, renal, and cardiac) within 14 days prior to enrollment.
Exclusion Criteria
- Any prior treatment for Non-Small Cell Lung Cancer including chemotherapy, biologic response modifiers or therapy with any investigational agents.
- Patients with known brain metastases, spinal cord compression, uncontrolled superior vein cava syndrome or carcinomatous meningitis.
- Patients with gastrointestinal abnormalities including active gastrointestinal bleeding, pre-diabetes (pre-fasting glycemia > 120 g/dL and/or glycosylate haemoglobin level > 7.5%), known HIV or AIDS-related illness, significant active cardiac disease or receiving chronic steroid therapy or concurrent use of growth hormones or growth hormone inhibitors or aminoglycoside antibiotics should be excluded from the study.
Data sourced from ClinicalTrials.gov (NCT00560573). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.