Rollover Study to Provide Continued Access to Napabucasin for Patients Enrolled in Boston Biomedical-sponsored Protocols

NCT04299880 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2023-11-08

No results posted yet for this study

Summary

This is an open-label, multi-center, multi-national, non-randomized rollover study designed to allow continued access to napabucasin for patients who have participated in a Boston Biomedical-sponsored study and are being treated with napabucasin (monotherapy or combination) and who are deriving continued clinical benefit in the parent study at the time of closure.

Conditions

Interventions

DRUG

Napabucasin

Oral

DRUG

Nab-paclitaxel

Intravenous

DRUG

Gemcitabine

Intravenous

DRUG

Nivolumab

Intravenous

DRUG

Paclitaxel

Intravenous

DRUG

Irinotecan

Intravenous

DRUG

Leucovorin

Intravenous

DRUG

5Fluorouracil

Intravenous

DRUG

Bevacizumab

Intravenous

Sponsors & Collaborators

  • Sumitomo Pharma America, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-24
Primary Completion
2021-05-15
Completion
2021-05-30
FDA Drug
Yes

Countries

  • United States
  • France
  • Japan
  • Taiwan

Study Locations

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Entities

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 NCT04299880 on ClinicalTrials.gov