MedTrace Logo

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

NCT02432326 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 147

Last updated 2023-11-08

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Sumitomo Pharma America, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2019-12-31
Completion
2020-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02432326 on ClinicalTrials.gov