Entry Detail
| General information | |
| Database: | DB00199 |
| Objective: | Metastatic melanoma cells express a number of protein tyrosine kinases (PTKs) that are considered to be targets for imatinib. They conducted a phase II trial of imatinib in patients with metastatic melanoma expressing at least one of these PTKs. |
| Authors: | Kim KB, et al |
| Title: | Phase II trial of imatinib mesylate in patients with metastatic melanoma. |
| Journal: | Br J Cancer. |
| Year: | 2008 |
| PMID: | 18728664 |
| Trial Design | |
| Clinical Trial Id: | Core Grant no. CA16672. |
| Agent: | imatinib mesylate |
| Target: | Abl Plateletderived growth factor receptor Mast/stem cell growth factor receptor |
| Cancer Type: | melanoma |
| Cancer Subtype: | advanced melanoma |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | an openlabel, phase II clinical trial |
| Key Patients Feature: | patients with metastatic melanoma expressing at least one of these PTKs (ckit, plateletderived growth factor receptors, cabl, or ablrelated gene) |
| Biomarker: | protein tyrosine kinases (PTKs) (ckit, plateletderived growth factor receptors, cabl, or ablrelated gene) expressions |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Pts were treated with 400 mg of imatinib twice daily. |
| Primary End Point: | ORR, safety and efficacy |
| Secondary End Point: | NA |
| Patients Number: | 21 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | One patient with metastatic acral lentiginous melanoma, containing the highest ckit expression among all patients, had dramatic improvement on positron emission tomographic scan at 6 weeks and had a partial response lasting 12.8 months. The responder had a substantial increase in tumour and endothelial cell apoptosis at 2 weeks of treatment. |
| Disease Control Rate: | not mentioned |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | Imatinib was fairly well tolerated: no patient required treatment discontinuation because of toxicity. Fatigue and oedema were the only grade 3 or 4 toxicities that occurred in more than 10% of the patients. |
| Conclusions: | Imatinib at the studied dose had minimal clinical efficacy as a singleagent therapy for metastatic melanoma. Hotheyver, based on the characteristics of the responding tumour in our study, clinical activity of imatinib, specifically in patients with melanoma with certain ckit aberrations, should be examined. |