Phase 1
Completed N=19
Study of CP-751,871 in Combination With Carboplatin and Paclitaxel in Advanced Lung Cancer
Source: ClinicalTrials.gov NCT00603538 ↗Enrolled (actual)
19
Serious AEs
10.5%
Results posted
Apr 2013
Primary outcomePrimary: Number of Participants With Dose Limiting Toxicities (DLT) — 1; 2; 0 participants
Summary
Investigate safety, tolerability and pharmacokinetics of CP-751,871 when given in combination with carboplatin and paclitaxel in patients with advanced non-small cell lung cancer
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Dose Limiting Toxicities (DLT) |
1; 2; 0 | — |
| SECONDARY Maximum Observed Concentration (Cmax) of CP-751,871 |
113; 197; 485; 178; 294; 550 | — |
| SECONDARY Plasma Decay Half-Life (t1/2) |
264; NA; 248 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve From Time 0 to Day 22 (AUC0-day22) |
22400; 36700; 82700 | — |
| SECONDARY Area Under the Plasma Concentration Curve From Time Zero to Tau (AUCtau) |
NA; NA; NA | — |
| SECONDARY Observed Accumulation Ratio (Rac) |
NA; NA; NA | — |
| SECONDARY Serum Concentrations of Total Insulin-like Growth Factor 1 (IGF-1) |
126.2; 167.7; 136.8; 518.3; 611.7; 493.8 | — |
| SECONDARY Serum Concentrations of Total Insulin-like Growth Factor Binding Protein-3 (IGF-BP-3) |
2.38; 2.26; 2.55; 4.35; 4.20; 3.85 | — |
| SECONDARY Number of Participants With Positive Anti-Drug Antibody (ADA) Specific to CP-751,871 Following an Intravenous Infusion of CP-751,871. |
0; 0; 0 | — |
| SECONDARY Number of Participants With Objective Response |
0; 0; 0; 1; 3; 3 | — |
| SECONDARY Progression-Free Survival (PFS) |
— | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00603538). 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.