Phase 2
Completed N=61
Combination Study Of CP-751,871 With Paclitaxel And Carboplatin In Advanced Lung Cancer
Source: ClinicalTrials.gov NCT00147537 ↗Enrolled (actual)
61
Serious AEs
41.3%
Results posted
Apr 2013
Primary outcomePrimary: Maximum Tolerated Dose (MTD)of CP-751,871 in Combination With Paclitaxel and Carboplatin: Phase 1b — NA mg/kg
Summary
Phase 1b Dose Excalation/Expansion: Identify and characterize safety and tolerability of recommended phase 2 dose of CP-751,871 when administered with paclitaxel and carboplatin Phase 1b Erlotinib Extension: To characterize the safety and tolerability of CP751,871 when administered with paclitaxel, carboplatin and erlotinib.
Phase 2: To test the efficacy of CP-751,871 combined with paclitaxel and carboplatin in the treatment of advanced non-small cell lung cancer
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose (MTD)of CP-751,871 in Combination With Paclitaxel and Carboplatin: Phase 1b |
NA | — |
| PRIMARY Recommended Phase 2 Dose (RP2D): Phase 1b |
20 | — |
| PRIMARY Objective Response Rate: Phase 2 |
37.4; 27.5 | =0.027 sig |
| PRIMARY Objective Response Rate in Non-Adenocarcinoma Participants: Phase 2 |
37.0 | =0.121 |
| SECONDARY Objective Response Rate: Phase 1b |
33.3; 25.0 | — |
| SECONDARY Number of Participants With Positive Human Anti-human Antibody (HAHA) Values: Phase 1b |
1; 0 | — |
| SECONDARY Number of Circulating Endothelial Cells (CECs): Phase 1b |
— | — |
| SECONDARY Number of Circulating Tumor-Related Cells (CTCs) and CTC Insulin-Like Growth Factor 1 Receptor (IGF-IR) Expression: Phase 1b |
— | — |
| SECONDARY Plasma Concentration of CP-751,871 at the End of Infusion (Cendinf) for Cycle 1 in Phase 1b |
1.510; 17.34; 37.47; 75.17; 147.3; 261.3 | — |
| SECONDARY Plasma Concentration of CP-751,871 at the End of Infusion (Cendinf) for Cycle 4 in Phase 1b |
2.975; 19.15; 40.70; 100.7; 327.0; 331.1 | — |
| SECONDARY Area Under the Curve From Time Zero to 504 Hours [AUC (0-504)] Post Infusion of CP-751,871 for Cycle 1 in Phase 1b |
22.30; 2011; 5320; 12810; 30500; 54650 | — |
| SECONDARY Area Under the Curve From Time Zero to 504 Hours [AUC (0-504)] Post Infusion of CP-751,871 for Cycle 4 in Phase 1b |
77.60; 2410; 23200; 52500; 94360; 214000 | — |
| SECONDARY Area Under the Curve From Time Zero Extrapolated to Infinite Time [AUCinf] for CP-751,871 for Cycle 1 in Phase 1b |
1434; 16750; 41200; 69180; 12100; 107400 | — |
| SECONDARY Plasma Decay Half-Life (t1/2) of CP-751,871 for Cycle 1 in Phase 1b |
2.84; 10.81; 8.350; 9.56; 11.10; 9.89 | — |
| SECONDARY Plasma Decay Half-Life (t1/2) of CP-751,871 for Cycle 4 in Phase 1b |
5.360; 15.40 | — |
| SECONDARY CP-751,871 Concentration at 504 Hours Post Dose (C504) for Cycle 1 (End of the 21-day Cycle) in Phase 1b |
0.1610; 4.550; 9.820; 28.20; 61.11; 95.20 | — |
| SECONDARY CP-751,871 Concentration at 504 Hours Post Dose(C504) for Cycle 4 (End of the 21-day Cycle) in Phase 1b |
0.0000; 0.4630; 27.70; 21.20; 125.3; 357.0 | — |
| SECONDARY Accumulation of CP-751,871 Ratio (Cycle 4 AUC504 / Cycle 1 AUC504) (Rac) in Phase 1b |
3.480; 1.009; 1.830; 1.550; 1.984; 2.260 | — |
| SECONDARY Area Under the Curve From Time Zero to Last Quantifiable Concentration of CP-751,871(AUClast) for Cycle 1 in Phase 1b |
16.60; 1235; 5137; 11350; 25630; 49260 | — |
| SECONDARY Area Under the Curve From Time Zero to Last Quantifiable Concentration of CP-751,871 (AUClast) for Cycle 4 in Phase 1b |
64.70; 2255; 2670; 23400; 70300; 82930 | — |
| SECONDARY Maximum Observed Plasma CP-751,871 Concentration (Cmax) for Cycle 1 in Phase 1b |
1.510; 17.34; 38.60; 75.17; 147.3; 275.2 | — |
| SECONDARY Maximum Observed Plasma CP-751,871 Concentration (Cmax) for Cycle 4 in Phase 1b |
2.975; 20.25; 40.70; 100.7; 327.0; 369.1 | — |
| SECONDARY Number of Participants With Positive Human Anti-human Antibody (HAHA) Values: Phase 2 |
0; 0 | — |
| SECONDARY M.D. Anderson Symptom Assessment Inventory (MDASI) in Phase 2 |
— | — |
| SECONDARY The European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC-QLQ-C30/-LC13) in Phase 2 |
— | — |
| SECONDARY Apparent Volume of CP-751,871 Distribution (Vd) for Cycle 4 in Phase 2 |
— | — |
| SECONDARY Clearance (CL) of CP-751,871 for Cycle 4 in Phase 2 |
— | — |
| SECONDARY Area Under the Curve From Time Zero to 504 Hours [AUC (0-504)] Post Infusion of CP-751,871 for Cycle 4 in Phase 2 |
— | — |
| SECONDARY CP-751,871 Concentration at 504 Hours Post Dose(C504) for Cycle 4 (End of the 21-day Cycle) in Phase 2 |
— | — |
| SECONDARY Maximum Observed Plasma CP-751,871 Concentration (Cmax) for Cycle 4 in Phase 2 |
— | — |
| SECONDARY Progression-Free Survival (PFS): Phase 2 |
4.4; 4.5; 4.3; 5.1 | — |
| SECONDARY Time to Progression (TTP) in Phase 2 |
— | — |
| SECONDARY Duration of Response (DR) in Phase 2 |
— | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of advanced/metastatic lung cancer
Exclusion Criteria
- Previous treatment with chemotherapy
- Uncontrolled diabetes
- History/active cardiovascular disease
Data sourced from ClinicalTrials.gov (NCT00147537). 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.