Entry Detail
| General information | |
| Database: | DB00978 |
| Objective: | they sought to determine the maximal tolerated dose of the MEK inhibitor trametinib with weekly paclitaxel, with a view to exploring the combination's activity in melanoma lacking a BRAF V600 mutation. |
| Authors: | Coupe N, et al |
| Title: | PACMEL: a phase 1 dose escalation trial of trametinib (GSK1120212) in combination with paclitaxel. |
| Journal: | Eur J Cancer |
| Year: | 2015 |
| PMID: | 25542057 |
| Trial Design | |
| Clinical Trial Id: | NA |
| Agent: | trametinib |
| Target: | MEK2 Dual specificity mitogenactivated protein kinase kinase 1 |
| Cancer Type: | melanoma |
| Cancer Subtype: | melanoma lacking a BRAF V600 mutation |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | trametinib (GSK1120212) + paclitaxel |
| Study Type: | a phase I dose escalation trial |
| Key Patients Feature: | Eligible patients had advanced melanoma and could have received up to two previous lines of treatment for metastatic disease. |
| Biomarker: | V600 BRAF mutation |
| Biomark Analysis: | In this small group promising progression free and overall survival were observed in patients with melanoma lacking a V600 BRAF mutation |
| Control Group Info: | single arm |
| Treatment Info: | they used a fixed dose of paclitaxel (80 mg/m2 intravenous (IV) on days 1, 8 and 15 of each 4 week cycle) and escalated the dose of trametinib (to a maximum 2mg orally (PO) daily), following a 3+3 design. |
| Primary End Point: | MTD, adverse event |
| Secondary End Point: | NA |
| Patients Number: | 15 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 5.5 months (95% confidence interval (CI) 1.87.8 months) |
| Median OS A vs. C: | 14.1 months (95% CI 4.6not reached). |
| Adverse Event(agent arm): | NA |
| Conclusions: | Trametinib can safely be given with weekly paclitaxel at the full monotherapy dose. In this small group promising progression free and overall survival they were observed in patients with melanoma lacking a V600 BRAF mutation. |