Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Stomach Neoplasms

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Herbal and Botanical

Paclitaxel

Albumin-Bound Paclitaxel

Trastuzumab

Tubulin Modulators

Antimitotic Agents

Sage

AZD8931

Placebo

IV once weekly for 3 weeks followed by a week off.

Serban Ghiorghiu, M. D.

The purpose of the study is to assess the efficacy and safety and PK of AZD8931 plus paclitaxel versus paclitaxel alone in patients with metastatic, gastric or gastro-oesophageal junction, cancer.

A Phase IIa 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 (SAGE)

Assess the Efficacy of AZD8931 in Combination With Paclitaxel Versus Paclitaxel Alone in Patients With Gastric Cancer

A Phase IIa 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 (SAGE)

Time from the date of randomization until the date of objective disease progression (as per RECIST1.1) or the date of death (by any cause in absence of progression).

The number of subjects with at least one visit response of CR or PR. (Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD), A ≥ 20% increase in the sum of diameters of target lesions and an absolute increase of ≥ 5mm; Stable disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Not Evaluable (NE), All target lesion measurements are missing or \>1/3 target lesion measurements are missing and sum of diameters of non-missing target lesions does not qualify for PD; Not applicable (NA), No target lesions are recorded at baseline)

AstraZeneca

AZD8931 40 mg bd (Twice daily) administered orally in combination with paclitaxel 80 mg/m2 administered intravenously \[approximately 1 hour duration\] on D1, 8 and 15 of each 28 day treatment cycle

AZD8931 40mg + Paclitaxel

AZD8931 matching placebo bd administered orally in combination with paclitaxel 80 mg/m2 administered intravenously \[approximately 1 hour duration\] on D1, 8 and 15 of each 28 day treatment cycle

Placebo + Paclitaxel

Total

Age, Continuous

18 - < 50 years

50 - < 65 years

65 - < 75 years

>= 75 years

Age, Customized

Sex: Female, Male

Asian

Race/Ethnicity, Customized

Asian (Other Than Chinese or Japanese)

Chinese

Japanese

HER2 0 No staining/membrane staining <10% of cells

HER2 1+ Faint membrane staining ≥10% of cells

HER2 2+ Weak/moderate membrane staining ≥10% cells

HER2 Status (Local Labs): HER2/IHC (Local Assessment)

HER2 Status: HER2/IHC (Local Assessment)

Dr Serban Ghiorghiu

60 patients had been considered to detect a -20% difference in the estimated average percentage change in tumour size at 8 weeks for AZD8931 plus paclitaxel compared to paclitaxel alone at a one-sided significance level of 10% with 90% power. This is based on a standard deviation of 30% for tumour data (on an absolute scale)

AZD8931 + Paclitaxel

Change in Tumour Size at 8 Weeks Were Analyzed for Comparing Relative Efficacy of AZD8931 Plus Paclitaxel With Paclitaxel Alone

Progression-free Survival (PFS) Were Analysed for Comparing Relative Efficacy of AZD8931 Plus Paclitaxel With Paclitaxel Alone

Complete Response

Partial Response

The Objective Response Rate (ORR) Was Analysed for Investigating the Efficacy of AZD8931 Plus Paclitaxel With Paclitaxel Alone

Overall Study

Spots Global Cancer Trial Database for metastatic gastric cancer who progress following first line therapy and are ineligible for treatment with trastuzumab by her2 status