A Phase I Clinical Study of BBI608 Administered with Paclitaxel in Patients with Previously treated Unresectable/Recurrent Gastric Cancer

Phase 1

• Conditions: nresectable/recurrent gastric cancer

• Registration Number: JPRN-jRCT2080222370
• Lead Sponsor: Sumitomo Dainippon Pharma Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-17
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 6

Inclusion Criteria

- Signed, written informed consent
- Unresectable/recurrent gastric cancer which was histologically confirmed as an adenocarcinoma (including adenocarcinomas of the gastroesophageal junction)
- Disease progression after one or more chemotherapy regimens OR recurrence within 6 months of completion of postoperative adjuvant therapy for unresectable/recurrent gastric cancer
- Maintained normal organ functions
- ECOG performance status of 0 or 1
etc.

Exclusion Criteria

- Patients with any known untreated brain metastases
etc.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- Safety<br>- Pharmacokinetics<br>CTCAE (ver.4.0)

Secondary Outcome Measures

Name	Time	Method
- Efficacy<br>RECIST (ver.1.1)