Phase 2
Completed N=168
Study Using CP-751,871 In Patients With Stage IV Colorectal Cancer That Has Not Responded To Previous Anti-Cancer Treatments
Source: ClinicalTrials.gov NCT00560560 ↗Enrolled (actual)
168
Serious AEs
64.9%
Results posted
May 2013
Primary outcomePrimary: Estimate of the 6 Month Survival Probability — 49.4; 44.1 Percent chance of survival — p=>0.05
Summary
This study will test if there is any survival benefit in patients with refractory metastatic colorectal cancer that receive CP-751, 871.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Estimate of the 6 Month Survival Probability |
49.4; 44.1 | >0.05 |
| SECONDARY Overall Survival |
5.8; 5.6 | — |
| SECONDARY Progression-Free Survival (PFS) |
1.4; 1.4 | — |
| SECONDARY Percentage of Participants With Objective Response |
0; 0 | — |
| SECONDARY Descriptive Summary of Figitumumab Concentration Versus Time |
647.0; 877.7; 244.0; 221.0; 255.7; 245.0 | — |
| SECONDARY Participants Reporting Positive for Total Anti-drug Antibodies (ADA) |
— | — |
| SECONDARY Counts of Circulating Tumor Cells (CTCs) Expressing Positive Insulin-like Growth Factor 1 Receptor (IGF-1R) |
2.02; 0.54; 0.22; 0.00 | — |
| SECONDARY Counts of Circulating Tumor Cells (CTCs) |
7.25; 4.90; 1.26; 2.18 | — |
Eligibility Criteria
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-cancer therapy.
- Patients who have previously received anti-cancer therapy that works like CP-751, 871 (targets insulin-like growth factor receptor)
- Patients that are pregnant or breast-feeding
Data sourced from ClinicalTrials.gov (NCT00560560). 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.