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

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

Status
Unknown
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080222370
Enrollment
6
Registered
2014-01-17
Start date
2014-01-17
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unresectable/recurrent gastric cancer

Interventions

Sponsors

Sumitomo Dainippon Pharma Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: - Patients with any known untreated brain metastases etc.

Design outcomes

Primary

MeasureTime frame
- Safety - Pharmacokinetics CTCAE (ver.4.0)

Secondary

MeasureTime frame
- Efficacy RECIST (ver.1.1)

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026