NCT02432326

A Study of BBI608 and BBI503 Administered in Combination to Adult Patients With Advanced Solid Tumors

A Phase Ib Clinical Study of BBI608 and BBI503 Administered in Combination to Adult Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 147 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open label, multi-center, phase 1 study of BBI608 and BBI503 administered orally in combination to patients with advanced solid tumors. The primary goal is to determine the safety, tolerability, and recommended phase II dose (RP2D) of the combination regimen.

Conditions

• Cancer
• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	BBI608	The BBI608 starting dose is 240 mg twice daily (480 mg total daily). Dose will be decreased to 160 mg twice daily (320 mg total daily) at modification level 2 and 80 mg twice daily (160 mg total daily) at modification level 3. For BBI608 once daily dosing, doses at starting level and modification level 1 are 240 mg once daily, and 480 mg once daily at escalated levels. Dose will be decreased to 160 mg once daily at modification level 2 and 80 mg once daily at modification level 3.
DRUG	BBI503	The BBI503 starting dose is 200 mg once daily. Dose at modification level 1 to 3 will be 100 mg once daily.

Timeline

• Start date: 2015-04-01
• Primary completion: 2019-12-01
• Completion: 2020-04-01
• First posted: 2015-05-04
• Last updated: 2023-11-08

Locations

11 sites across 1 country: United States