Table 1.
CNS TAP Tool | |||
---|---|---|---|
Description of Points | Weight | Range of Points | |
Pre-Clinical Data (in vitro) | 0 = No data 1 = Activity against any cell type 2 = Activity against primary CNS tumor cell type |
2 | 0 to 4 |
Pre-Clinical Data (in vivo) | 0 = No data 1 = Activity against cells grafted into the flank 2 = Activity against orthotopic cells or cells grafted into the brain |
3 | 0 to 6 |
Phase I Safety Data | 0 = No data 1 = Ongoing pediatric clinical trial 2 = Published phase I trial with phase I dosing |
3 | 0 to 6 |
CNS Data with Response | −2 = Evidence of lack of positive response of primary CNS tumors −1 = Evidence of lack of positive response of brain metastasis 0 = No data 1 = Evidence of positive response of a brain metastasis 2 = Evidence of positive response of a primary CNS tumor |
5 | −10 to 10 |
Brain Penetration | 0 = Insufficient CNS penetration 1 = < 5% CNS penetration but Cmax above IC50 2 = > 5% CNS penetration and Cmax above IC50 |
5 | 0 to 10 |
FDA Approval | 0 = No FDA approval 1 = FDA approval |
10 | 0 to 10 |
Clonality/variant allele fraction (%) | 0 = Pathway is non-dominant mutation 1 = Pathway is dominant mutation |
5 | 0 to 5 |
Variant Tier Score | 0 = Tier IV 1 = Tier III 2 = Tier I or Tier II |
3 | 0 to 6 |
Relevant Clinical Trial | 0 = No clinical trial considered 2 = Clinical trial is available that the patient is eligible for and willing to travel to |
10 | 0 to 20 |