PROFILE 1001
Anaplastic lymphoma kinase inhibition in non-small-cell lung cancer: expanded cohort of the crizotinib phase 1 study
Phase 1N = 82NCT00585195
- Population
- Advanced ALK-positive NSCLC identified by screening about 1500 tumour samples; most had received previous treatment
- Design
- Single-group expanded cohort after phase 1 dose escalation established crizotinib 250 mg twice daily in 28-day cycles; patients assessed for adverse events and response
- Arms
- Crizotinib (experimental, n = 82): Crizotinib 250 mg twice daily in 28-day cycles
- People
- Kwak EL
Show the numbers
| Endpoint | Analysis | Crizotinib | Control | Effect |
|---|---|---|---|---|
| ORRALK-positive expanded cohort (n=82) | interimKwak 2010 | 57% (46–68%) | — | 47 of 82 patients responded (46 confirmed partial responses, 1 confirmed complete response), 95% CI 46 to 68 (full text); 27 patients (33%) had stable disease. Mean treatment duration was 6.4 months at the data cut-off, with follow-up ongoing and 63 of 82 (77%) still receiving crizotinib. Labelled 'interim' on that basis; the paper does not name the analysis type. |
| PFSALK-positive expanded cohort (n=82) | exploratorymedian follow-up 6.4 monthsKwak 2010 | 72% at 6 mo (61–83%) | — | No median PFS had been reached. The paper states that the trial was not designed to address PFS as an end point, that responses in ALK-positive patients were unanticipated when the protocol was written, and that previous treatments were heterogeneous; median follow-up for PFS was 6.4 months (95% CI 5.5 to 7.2). |
| Endpoint | Analysis | Crizotinib | Control | Effect |
|---|---|---|---|---|
| ORRALK-positive expanded cohort (n=82) | interimKwak 2010 | 57% (46–68%) | — | 47 of 82 patients responded (46 confirmed partial responses, 1 confirmed complete response), 95% CI 46 to 68 (full text); 27 patients (33%) had stable disease. Mean treatment duration was 6.4 months at the data cut-off, with follow-up ongoing and 63 of 82 (77%) still receiving crizotinib. Labelled 'interim' on that basis; the paper does not name the analysis type. |
| PFSALK-positive expanded cohort (n=82) | exploratorymedian follow-up 6.4 monthsKwak 2010 | 72% at 6 mo (61–83%) | — | No median PFS had been reached. The paper states that the trial was not designed to address PFS as an end point, that responses in ALK-positive patients were unanticipated when the protocol was written, and that previous treatments were heterogeneous; median follow-up for PFS was 6.4 months (95% CI 5.5 to 7.2). |