CDNKN2A Loss Defined Clinical Trial
Official title:
An Open Label Multicenter, Phase I-II Study With Tumor Molecular Pharmacodynamic (MPD) Evaluation and Pharmacokinetics of PD-0332991 in Patients Suffering Metastatic Melanoma With BRAFv600 Mutated and CDKN2A Loss and Expression of Rb and Treated by Vemurafenib
An open label multicentre, phase I-II study with tumour molecular pharmacodynamics (MPD)
evaluation and pharmacokinetics of PD-0332991 added to vemurafenib in patients suffering
metastatic melanoma with BR.
The main objective is to establish the Maximum Tolerated Dose (MTD) of PD-0332991 when added
to standard vemurafenib therapy (960 mg BID). The estimated MTD is defined as the dose of
PD-0332991 combined with vemurafenib that will be associated with a prespecified proportion
of patients experiencing a Dose-Limiting Toxicity (DLT), ie, 1/3.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment