SNPMiner Trials: Clinical Trial Report
Report for Clinical Trial NCT01325441
Developed by Shray Alag, 2019.
SNP Clinical Trial Gene
This is an open label, single arm phase 1 dose escalation study and phase 2 study of BBI608
in combination with paclitaxel in patients with advanced malignancies. Currently the study is
only enrolling patients with thymic carcinoma.
NCT01325441 Cancer
2 Interventions
Name: BBI608
Type: Drug
BBI608 and Paclitaxel
Name: Paclitaxel
Type: Drug
BBI608 and Paclitaxel
Primary Outcomes
Measure: Safety by reporting the adverse events and serious adverse events
Time: 6 months
Measure: Determination of the Recommended Phase 2 Dose by assessing dose-limiting toxicities (DLTs)
Time: 6 months
Secondary Outcomes
Measure: Preliminary anti-tumor activity of BBI608 when administered in combination with paclitaxel in patients with advanced malignancies by performing tumor assessments every 8 weeks
Time: 6 months
Measure: Pharmacokinetic profile of BBI608 and paclitaxel assessed by area under the plasma concentration versus time curve
Time: On Day 3 and Day 17 of the first cycle prior to dosing and 0.5, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 8.5, 9, 10, 11, 24 and 27 hours after first dose
Purpose: Treatment
Single Group Assignment
There are 2 SNPs
SNPs
If
melanoma is positive for the V600E or V600K BRAF mutation, must have received at least
one line of prior therapy with a BRAF-specific inhibitor; either alone or in
combination. --- V600E ---
If
melanoma is positive for the V600E or V600K BRAF mutation, must have received at least
one line of prior therapy with a BRAF-specific inhibitor; either alone or in
combination. --- V600E --- --- V600K ---
HPO Nodes