NLP SNP

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.

NCT00381654 Tumor

1 Interventions

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: Drug

Primary Outcomes

Measure: To evaluate the safety, tolerability, and dose-limiting toxicities (DLT), and determine the maximum tolerated dose (MTD) of AV-412 when administered once daily by the oral route for 4 weeks (4 weeks equals one dosing cycle)

Time: one year

Secondary Outcomes

Measure: To characterize the pharmacokinetic (PK) profile of AV-412 in all patients. Extensive PK collection and assay to be performed in expanded MTD Cohorts

Time: 18 months

Measure: Evaluate potential pharmacodynamic (PD) markers of AV-412 action, in expanded MTD Cohorts ONLY

Time: two years

Measure: Preliminary evaluation of the antineoplastic activity of AV-412 (assessed by evidence and duration of disease stabilization or objective response, and time to disease progression)

Time: two years

Purpose: Treatment
Allocation: Non-Randomized
Single Group Assignment

There is one SNP

SNPs

1 L858R

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 ---

SNPMiner Trials by Shray Alag

SNPMiner Trials: Clinical Trial Report

Report for Clinical Trial NCT00381654

Developed by Shray Alag, 2019.

SNP Clinical Trial Gene

A Phase 1, Sequential Cohort, Dose Escalation Trial to Determine the Safety, Tolerability, and Maximum Tolerated Dose of Daily Oral Administration of AV-412 in Patients With Refractory or Relapsed Solid Tumor Malignancies