Evidence map›Paper›PMID 37188895›Full record

ArticleDrugs in R&D2023

A Phase I Study to Investigate the Safety, Tolerability and Pharmacokinetics of Napabucasin Combined with Sorafenib in Japanese Patients with Unresectable Hepatocellular Carcinoma.

Takuji Okusaka, Manabu Morimoto, Yuichiro Eguchi, Shinichiro Nakamura, Shuichi Iino, Rie Kageyama

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Drugs in R&D, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02358395 (A Phase I Study of BBI608 Administrated With Sorafenib in Adult Patients With Advanced Hepatocellular Carcinoma), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
2.2field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02358395 phase1completednot on this map

A Phase I Study of BBI608 Administrated With Sorafenib in Adult Patients With Advanced Hepatocellular Carcinoma

TypeinterventionalSponsorSumitomo Pharma Co., Ltd.Ran2015 to 2017Enrolled12ConditionsHepatocellular CarcinomaArmsBBI608, Sorafenib
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 10 citations in OpenAlex.

  1. Article
  2. Hepatocellular carcinoma: signaling pathways and therapeutic advances.Signal transduction and targeted therapy · 2025
    Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 5 institutions in 1 country.

Takuji OkusakaDepartment of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan. tokusaka@ncc.go.jp.ORCID http://orcid.org/0000-0003-1729-807X
Manabu MorimotoHepatobiliary and Pancreatic Oncology, Kanagawa Cancer Center, Yokohama, Japan.
Yuichiro EguchiLiver Center, Saga University Hospital, Faculty of Medicine Saga University, Saga, Japan.
Shinichiro NakamuraDepartment of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.
Shuichi IinoSumitomo Pharma Co., Ltd, Tokyo, Japan.
Rie KageyamaSumitomo Pharma Co., Ltd, Tokyo, Japan.
Sumitomo Dainippon Pharma (Japan) · JPKanagawa Prefectural Hospital Organization · JPNational Cancer Centre Japan · JPOkayama University · JPSaga University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveFor patients with advanced hepatocellular carcinoma (HCC), the standard of care for many years has been sorafenib. Preliminary data have suggested that the combination of the NAD(P)H:quinone oxidoreductase 1 bioactivatable agent napabucasin plus sorafenib may improve clinical outcomes in patients with HCC. In this phase I, multicenter, uncontrolled, open-label study, we evaluated napabucasin (480 mg/day) plus sorafenib (800 mg/day) in Japanese patients with unresectable HCC.

methodsAdults with unresectable HCC and an Eastern Cooperative Oncology Group performance status of 0 or 1 were enrolled in a 3 + 3 trial design. The occurrence of dose-limiting toxicities was assessed through 29 days from the start of napabucasin administration. Additional endpoints included safety, pharmacokinetics, and preliminary antitumor efficacy.

resultsIn the six patients who initiated treatment with napabucasin, no dose-limiting toxicities occurred. The most frequently reported adverse events were diarrhea (83.3%) and palmar-plantar erythrodysesthesia syndrome (66.7%), all of which were grade 1 or 2. The pharmacokinetic results for napabucasin were consistent with prior publications. The best overall response (per Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1) was stable disease in four patients. Using Kaplan-Meier methodology, the 6-month progression-free survival rate was 16.7% per RECIST 1.1 and 20.0% per modified RECIST for HCC. The 12-month overall survival rate was 50.0%.

conclusionsThese findings confirm the viability of napabucasin plus sorafenib treatment, and there were no safety or tolerability concerns in Japanese patients with unresectable HCC. CLINICAL

trial registrationClinicalTrials.gov identifier NCT02358395, registered on 9 February 2015.

Indexed as

BenzofuransCarcinoma, HepatocellularLiver NeoplasmsNaphthoquinonesAdultAntineoplastic Combined Chemotherapy ProtocolsEast Asian PeopleHumansSorafenibBenzofuransnapabucasinNaphthoquinonesSorafenib

Identifiers

PMID37188895
PMCPMC10293504
OpenAlexW4376642849

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.