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A Phase 2a Multi-centre Randomised Double-Blind Placebo-controlled Study to Assess the Efficacy, Safety and Pharmacokinetics of AZD8931 in Combination With Paclitaxel Versus Paclitaxel Alone in Patients With Metastatic, Gastric or Gastro-oesophageal Junction, Cancer Who Progress Following First Line Therapy and Are Ineligible for Treatment With Trastuzumab by HER2 Status

A Phase 2a Multi-centre Randomised Double-Blind Placebo-controlled Study to Assess the Efficacy, Safety and Pharmacokinetics of AZD8931 in Combination With Paclitaxel Versus Paclitaxel Alone in Patients With Metastatic, Gastric or Gastro-oesophageal Junction, Cancer Who Progress Following First Line Therapy and Are Ineligible for Treatment With Trastuzumab by HER2 Status

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080221824
Enrollment
Unknown
Registered
2012-06-28
Start date
2012-06-28
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

Metastatic, Gastric or Gastro-oesophageal Junction, Cancer

Interventions

investigational material(s) Generic name etc : AZD8931 INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material

Sponsors

AstraZeneca
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Male or female aged 18 years or older (20 years or older in Japan) - Patients must have radiologically confirmed progression following 1st line fluoropyrimidine/platinum based treatment for metastatic gastric cancer (the date of progression and start of first line treatment to be captured on the database) - Suitable for paclitaxel therapy - At least one lesion, not previously irradiated and not chosen for an optional fresh biopsy during the study screening period, that can be accurately measured at baseline as greater or equal than 10mm in longest diameter (except lymph nodes which must have short axis greater or equal than 15mm - Ineligible for trastuzumab treatment by local assessment. This should include IHC analysis to determine HER2 status with further testing by FISH/CISH when considered part of local practice. - Eligible patients are those defined as; HER2 IHC 0, HER2 IHC+1 and +2

Exclusion criteria

Exclusion criteria: - Have received more than 1 prior chemotherapy regimen for metastatic gastric cancer. (chemotherapy as adjuvant treatment is permitted). - Any prior taxane therapy (at any time from diagnosis of gastric cancer) - Any prior therapy with an inhibitor of ErbB1 (EGFR) or ErbB2 (HER2) (eg, lapatinib) - Resting ECG with measurable QTc(F) interval of greater than 480 msec at 2 or more time points within a 24 hour period (see section 6.4.9.1) - Unresolved toxicity grater than CTCAE grade 2 (except alopecia) from previous anti-cancer therapy

Outcome results

None listed

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