| General information |
| Database: | DB00067 |
| Objective: | ALK fusion genes occur in a subset of non small cell lung cancers (non small cell lung cancers). they assessed the tolerability and activity of crizotinib in patients with non small cell lung cancer who were prospectively identified to have an ALK fusion within the firstinmanphase 1 crizotinib study. |
| Authors: | Camidge DR, et al |
| Title: | Activity and safety of crizotinib in patients with ALKpositive non small cell lung cancer: updated results from a phase 1 study. |
| Journal: | Lancet Oncol. |
| Year: | 2012 |
| PMID: | 22954507 |
| Trial Design |
| Clinical Trial Id: | NCT00585195 |
| Agent: | crizotinib
|
| Target: | Hepatocyte growth factor receptor, ALK, ROS1
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | advanced ALKrearranged non small cell lung cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | Phase I:firstinman singlearm crizotinib study |
| Key Patients Feature: | Patients aged 18 years or older with measurable ALKpositive stage III or IV non small cell lung cancer ethnic origin: white(64%), Asian(28%), other(9%) |
| Biomarker: | ALKpositive |
| Biomark Analysis: | Crizotinib is well tolerated with rapid, durable responses in patients with ALKpositive non small cell lung cancer. |
| Control Group Info: | single arm |
| Treatment Info: | pts received oral crizotinib 250 mg twice daily in 28day cycles. |
| Primary End Point: | tumour responses, duration of response, time to tumour response, progression free survival (PFS), overall survival at 6 and 12 months, and determination of the safety and tolerability and characterisation of the plasma pharmacokinetic profile of crizotinib after oral administration. |
| Secondary End Point: | NA |
| Patients Number: | 143 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | ORR 60.8%, 95% CI 52.368.9 |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 9.7 (95% CI 7.712.8) |
| Median OS A vs. C: | estimated OS at 6 and 12 m. was 87.9% (95% CI 81.39.3) and 74.8% (66.481.5) |
| Adverse Event(agent arm): | treatmentrelated adverse events rate:97%;grade 1 or 2:visual effects, nausea, diarrhoea, constipation, vomiting, and peripheral oedema;grade 3 or 4:neutropenia (n=9), raised alanine aminotransferase (n=6), hypophosphataemia (n=6), and lymphopenia (n=6). |
| Conclusions: | Crizotinib is well tolerated with rapid, durable responses in patients with ALKpositive non small cell lung cancer. |