| General information |
| Database: | DB00757 |
| Objective: | Vorinostat has been shown to overcome resistance to gefitinib. they performed a phase I/II study combining gefitinib with vorinostat in previously treated non small cell lung cancer (non small cell lung cancer). |
| Authors: | Han JY, et al |
| Title: | Phase I/II study of gefitinib (Iressa( )) and vorinostat (IVORI) in previously treated patients with advanced non small cell lung cancer. |
| Journal: | Cancer Chemother Pharmacol. |
| Year: | 2015 |
| PMID: | 25552401 |
| Trial Design |
| Clinical Trial Id: | NCT01027676 |
| Agent: | gefitinib
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | advanced non small cell lung cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a phase I/II study |
| Key Patients Feature: | previously treated patients with advanced non small cell lung cancer. |
| Biomarker: | EGFRmutant |
| Biomark Analysis: | In EGFRmutant non small cell lung cancer, response rate was 77 %, median PFS was 9.1 months, and median OS was 24.1 months. |
| Control Group Info: | doseescalation |
| Treatment Info: | A 3 + 3 doseescalation design was used to determine maximum tolerated dose (MTD) and recommendedphase II dose (RP2D). Three dose levels were tested: 250 mg/day gefitinib on days 128 and 200, 300 or 400 mg/day vorinostat on days 17, and 1521 out of every 28 days. |
| Primary End Point: | median progression free survival (PFS) |
| Secondary End Point: | NA |
| Patients Number: | 52 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 37.20% |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 3.2 months (95 % CI 2.3 to 4.1 months) |
| Median OS A vs. C: | 19.0 months (95 % CI 17.2 to 20.8 months) |
| Adverse Event(agent arm): | The most common adverse events were anorexia and diarrhea. |
| Conclusions: | Treatment with 250 mg gefitinib daily with biweekly 400 mgday vorinostat was feasible and well tolerated. In an unselected patient population, this combination dose did not improve PFS. Hotheyver, this combination showed a potential for improving efficacy of gefitinib in EGFRmutant non small cell lung cancer (NCT01027676). |