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Special Combination of BBI608 and Pembrolizumab

NCT02851004 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2021-09-05

No results posted yet for this study

Summary

the efficacy and safety of BBI608 in combination with pembrolizumab

Conditions

Interventions

DRUG

Napabucasin

1 cycle is 21days. BBI608: Oral administration at a dose of 240mg or 480 mg twice daily (BID), every day. \[Additional cohort to the Phase II part\] Oral administration at a dose of 240mg mg BID, every day The therapy will be repeated until meeting the discontinuation criteria.

DRUG

Pembrolizumab

1 cycle is 21days. Pembrolizumab: Administration at a dose of 200 mg/body on Day 1 of each cycle \[Additional cohort to the Phase II part\] Administration at a dose of 200 mg/body on Day 1 of each cycle. The therapy will be repeated until meeting the discontinuation criteria.

Sponsors & Collaborators

  • Sumitomo Pharma Co., Ltd.

    collaborator INDUSTRY

  • Takayuki Yoshino

    lead OTHER

Principal Investigators

  • Takayuki Yoshino, Dr · National Cancer Center Hospital East

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2020-02-03
Completion
2021-08-23

Countries

  • Japan

Study Locations

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Entities

Drugs
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 NCT02851004 on ClinicalTrials.gov