NCT02358395

Brief Summary

This is an open-label, multicenter, phase 1 study of BBI608 in combination with Sorafenib. This study population is adult Japanese patients with advanced hepatocellular carcinoma in Sorafenib combination therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 hepatocellular-carcinoma

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2015

Completed
11 days until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 9, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

April 12, 2022

Status Verified

April 1, 2022

Enrollment Period

2.8 years

First QC Date

January 21, 2015

Last Update Submit

April 9, 2022

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (3)

  • Assessment of safety and tolerability of BBI608 given in combination with Sorafenib by reporting of adverse events and serious adverse events.

    7 month

  • Assessment of dose-limiting toxicities (DLTs).

    29 days

  • Pharmacokinetic profile of BBI608 when administered in combination with Sorafenib.

    On day 1: Prior to BBI608 dosing and 2,4,6,8,10,12 and 24 hours after the first dose. On day 29: Prior to BBI608 dosing and 2,4,6,8,10,12 and 24 hours after the first dose.

Secondary Outcomes (3)

  • Assessment of the preliminary anti-tumour activity.

    Approximately 7 months

  • Progression Free Survival

    Approximately 7 month

  • Overall Survival

    Approximately 1 year

Study Arms (1)

BBI608 puls Sorafenib

EXPERIMENTAL
Drug: BBI608Drug: Sorafenib

Interventions

BBI608DRUG

Administered continuously twice daily with doses separated by 9-15 hours.

BBI608 puls Sorafenib
SorafenibDRUG

Sorafenib 400 mg twice daily (800 mg total daily dose).

BBI608 puls Sorafenib

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or diagnosed imaging with hepatocellular carcinoma, and not indicated with a)-d) .
  • Radiofrequency ablation therapy (RFA)
  • Local therapy \[such as percutaneous transhepatic ethanol injection therapy (PEIT), Microwave coagulation therapy (MCT)\]
  • Transcatheter arterial embolization (TAE)
  • Transcatheter arterial chemoembolization (TACE)
  • ≥ 20 years of age.
  • Not treatment with systemic chemotherapy.
  • Signed written informed consent must be obtained and documented.
  • Life expectancy ≥ 3 months.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Must be Child Pugh Class A.
  • Hemoglobin ≥ 8.5 mg/dl.
  • Absolute neutrophil count ≥ 1.5 x 10\^9 /L.
  • Platelets ≥ 75 x 10\^9/L.
  • Creatinine ≤ 1.5 x ULN.
  • +4 more criteria

You may not qualify if:

  • Have had any t a)-i) treatment less than 28 days prior to beginning the enrolment.
  • Radiation therapy
  • Hormone therapy
  • Immune therapy
  • Hyperthermia
  • Surgical procedure
  • Local therapy (such as RFA, PEIT, MCT)
  • TAE
  • TACE
  • other anti- tumour treatment
  • Have had a brain metastases with a symptom or requiring treatment.
  • Have had coinstantaneous active multiple cancers.
  • Have had a carcinomatous pleural effusion, ascites, or cardiac effusion requiring treatment.
  • Esophageal varix requiring treatment.
  • Patient of pregnancy or possibility of pregnancy, and planning breastfeeding by the end of BBI608 administration after 30days.
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

4 Sites

Tokyo,etc, Japan

Location

Related Publications (1)

  • Okusaka T, Morimoto M, Eguchi Y, Nakamura S, Iino S, Kageyama R. A Phase I Study to Investigate the Safety, Tolerability and Pharmacokinetics of Napabucasin Combined with Sorafenib in Japanese Patients with Unresectable Hepatocellular Carcinoma. Drugs R D. 2023 Jun;23(2):99-107. doi: 10.1007/s40268-023-00416-8. Epub 2023 May 15.

    PMID: 37188895DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

napabucasinSorafenib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Phenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Director, Drug Development Division

    Sumitomo Pharma Co., Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2015

First Posted

February 9, 2015

Study Start

February 1, 2015

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

April 12, 2022

Record last verified: 2022-04

Locations

JP(1)