SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT01325441

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Phase Ib/II Clinical Study of BBI608 Administered With Paclitaxel in Adult Patients With Advanced Malignancies

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


1 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 ---


2 V600K

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