A phase I study of BBI608, a cancer stemness inhibitor, administered with paclitaxel (PTX) as combination therapy (Rx) for pretreated unresectable or recurrent gastric cancer.

Shitara, Kohei; Kuboki, Yasutoshi; Nakamura, Yoshiaki; Doi, Ayako; Harada, Kazuaki; Kawazoe, Akihito; Doi, Toshihiko; Yoshino, Takayuki; Yodo, Yasuhide; Yoshikawa, Reigetsu; Ohtsu, Atsushi

doi:10.1200/jco.2015.33.15_suppl.e15089

Cited by 7 publications

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“…Their median age was 66.0 years and the majority of patients had an Eastern Cooperative Oncology Group performance score of 0 (5/6; 83.3%), and four patients had previously received two or more prior lines of therapy. All patients had received prior chemotherapy with fluoro-pyrimidines and platinum; three patients had received prior taxanes and two patients had received prior irinotecan (13). A total of three patients had undergone gastrectomy.…”

Section: Resultsmentioning

confidence: 99%

A Phase I Study of Napabucasin Plus Paclitaxel for Japanese Patients With Advanced/Recurrent Gastric Cancer

Shitara¹,

Yodo²,

Iino³

2019

In Vivo

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Aim: To report results from the first phase I study of napabucasin plus paclitaxel in Japanese patients with pretreated unresectable/recurrent gastric cancer. Patients and Methods: Patients received napabucasin (480 mg bid) plus paclitaxel [80 mg/m 2 on days 3, 10 and 17 (cycles 1 and 2) and on days 1, 8 and 15 (cycle 3 and subsequent cycles)] until disease progression or unacceptable toxicity. Primary objectives were tolerability, safety and pharmacokinetics of napabucasin plus paclitaxel. Trial registration ID: JapicCTI-142420. Results: Six patients were enrolled. Paclitaxel had a minimal effect on napabucasin pharmacokinetics and median plasma paclitaxel concentrations were similar in combination and monotherapy. No dose-limiting toxicities were observed. There were no grade 4/5 adverse events. Partial response, stable disease and progressive disease were reported in two patients each. Conclusion: Napabucasin plus paclitaxel was well-tolerated in Japanese patients with gastric cancer.

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Section: Resultsmentioning

confidence: 99%

A Phase I Study of Napabucasin Plus Paclitaxel for Japanese Patients With Advanced/Recurrent Gastric Cancer

Shitara¹,

Yodo²,

Iino³

2019

In Vivo

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“…Napabucasin combined with paclitaxel was studied in a phase 1, open-label study in Japan (JapicCTI-142420) in 6 patients with gastric cancer. 55 Napabucasin 480 mg twice daily was administered in combination with paclitaxel 80 mg/m 2 weekly on days 1, 8, and 15 of each 28day study cycle until patients developed disease progression or unacceptable toxicity. Of the 6 patients enrolled, 3 had previously received taxane therapy.…”

Section: Napabucasin In Clinical Trials Of Gastric/gej Cancersmentioning

confidence: 99%

“…In that study, napabucasin plus weekly paclitaxel was safely administered at full dose with promising efficacy signals. 55 In a phase 1b dose-escalation study (National Clinical Trials identifier NCT01325441; www.clinicaltrials. gov), patients with advanced solid tumors received napabucasin plus weekly paclitaxel.…”

Section: Napabucasin In Clinical Trials Of Gastric/gej Cancersmentioning

confidence: 99%

Identifying and targeting cancer stem cells in the treatment of gastric cancer

Bekaii‐Saab

El‐Rayes²

2017

Cancer

100

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Current treatment regimens for gastric cancer are not adequate. Cancer stem cells (CSCs) may be a key driving factor for growth and metastasis of this tumor type. In contrast to the conventional clonal evolution hypothesis, CSCs can initiate tumor formation, self‐renew, and differentiate into tumor‐propagating cells. Because gastric cancer can originate from CSCs, it is necessary to review current targets of signaling pathways for CSCs in gastric cancer that are being studied in clinical trials. These pathways are known to regulate the self‐renewal and differentiation process in gastric CSCs. A better understanding of the clinical results of trials that target gastric CSCs will lead to better outcomes for patients with gastric cancer. Cancer 2017;123:1303–1312. © 2017 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society. This is an open access article under the terms of the Creative Commons Attribution NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

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“…This review has highlighted some of the new STAT3 inhibitors coming through in early phase clinical trials. Of those discussed, napabucasin appears to be the most developed and has shown promise when partnered with paclitaxel [38][39][40], an accepted second-line drug with demonstrable efficacy in gastric cancer [45], and certainly the results of the BRIGHTER study will be eagerly awaited. Of note, given the toxicities noted to date with the STAT3 inhibitors, careful attention should be paid to the propensity for gastrointestinal upset, namely nausea, vomiting, and diarrhea, and active management of these toxicities will need to be addressed as these symptoms may be prominent in this patient group.…”

Section: Resultsmentioning

confidence: 97%

“…Two of the six achieved a partial response (66.7% and 36.8% regression), one with maintained response of >7.5 months. A further two patients obtained stable disease [40].…”

Section: Phase I Ib/ii and Iii Clinical Trials Of Napabucasin (Bbi608)mentioning

confidence: 97%

Novel STAT 3 inhibitors for treating gastric cancer

Cafferkey

Chau

2016

Expert Opinion on Investigational Drugs

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A phase I study of BBI608, a cancer stemness inhibitor, administered with paclitaxel (PTX) as combination therapy (Rx) for pretreated unresectable or recurrent gastric cancer.

Cited by 7 publications

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A Phase I Study of Napabucasin Plus Paclitaxel for Japanese Patients With Advanced/Recurrent Gastric Cancer

A Phase I Study of Napabucasin Plus Paclitaxel for Japanese Patients With Advanced/Recurrent Gastric Cancer

Identifying and targeting cancer stem cells in the treatment of gastric cancer

Novel STAT 3 inhibitors for treating gastric cancer

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