AV-412 is a new oral therapy developed to inhibit the growth of solid tumors in patients who have not responded to standard therapy or surgical interventions, or who have experienced relapse. This study will test the safety of AV-412 and determine the maximum tolerated dose for the treatment of solid tumors.
Name: AV-412
Description: Solid oral dosage; 4 dosage strengths; 25, 50, 100, or 200 mg per capsule Dosing Frequency: Once daily dosing for 4 weeks (4 weeks equals 1 cycle)Type: DrugA
Allocation: Non-Randomized
Single Group Assignment
There is one SNP
Criteria for Inclusion: 1. ≥ 18 year old males or females 2. Documented measurable or evaluable solid tumor malignancy that is relapsed, refractory, locally advanced, or metastatic 3. Patients entered to MTD Cohort B must have: - Histologically or cytologically confirmed NSCLC - No prior therapy with erlotinib, gefitinib, or any other EGFR-kinase inhibitor - Previously documented exon 19 deletion and/or exon 21 L858R mutations - Measurable disease according to RECIST 4. Disease that is currently refractory to, or not amenable to, standard therapy 5. Disease that is currently not amenable to surgical intervention, due to either medical contraindications or nonresectability of the tumor 6. Karnofsky performance status ≥ 70%, life expectancy ≥ 3 months 7. --- L858R ---
Inability to comply with protocol requirements Criteria for Inclusion: 1. ≥ 18 year old males or females 2. Documented measurable or evaluable solid tumor malignancy that is relapsed, refractory, locally advanced, or metastatic 3. Patients entered to MTD Cohort B must have: - Histologically or cytologically confirmed NSCLC - No prior therapy with erlotinib, gefitinib, or any other EGFR-kinase inhibitor - Previously documented exon 19 deletion and/or exon 21 L858R mutations - Measurable disease according to RECIST 4. Disease that is currently refractory to, or not amenable to, standard therapy 5. Disease that is currently not amenable to surgical intervention, due to either medical contraindications or nonresectability of the tumor 6. Karnofsky performance status ≥ 70%, life expectancy ≥ 3 months 7. --- L858R ---