Health Condition 1: null- Advanced Gastric or Gastro-oesophageal Junction Cancer Health Condition 2: C159- Malignant neoplasm of esophagus, unspecified
Conditions
Interventions
Intervention1: AZD4547: AZD4547 tablets, AZD4547 will be taken orally in a tablet formulation, in a 3-week cycle)
Control Intervention1: Paclitaxel: Paclitaxel mulitidose Vials, Paclitaxel will be ad
Sponsors
AstraZeneca AB
AstraZeneca Pharma India Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Pre-screening part of the study • Histological diagnosis of locally advanced or metastatic gastric adenocarcinoma (including adenocarcinoma of the lower third of the oesophagus or the gastrooesophageal junction. • Female or male aged 25 years or older Randomised part of study • Suitable for and expected to benefit from paclitaxel monotherapy • Patients must have radiologically confirmed progression following 1st line treatment for advanced or metastatic gastric adenocarcinoma (including adenocarcinoma of the lower third of the oesophagus or the gastro-oesophagealjunction). Patients who have progressed within 6 months following adjuvant orneo-adjuvant therapy may be included upon investigators discretion. • At least one lesion, not previously irradiated, that can be accurately measured at baseline as >= 10 mm in the longest diameter with CT or MRI and which is suitable for accurate repeated measurements.
Exclusion criteria
Exclusion criteria: Pre-screening part of the study • If the patient is unlikely to comply with study procedures, restrictions and requirements. Randomised part of study • Participation in another clinical study with an investigational product within 4weeks before commencing study treatment • Major surgery, radiotherapy with wide field of radiation or any cancer treatment within 4 weeks before the first dose of the study treatment. • With the exception of alopecia, any unresolved toxicities from prior therapy with a common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment. Any unresolved toxicity CTC grade 1 from previous radiotherapy except GI or haematological toxicity which must be completely resolved prior to commencing chemotherapy. • As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate the efficacy of AZD4547 compared with paclitaxel by assessment of progression-free survival (PFS) in all randomised patients and also in the patients with tumours that have FGFR2 amplification (FISH score 6) aloneTimepoint: RECIST assessments will be performed at baseline and every 8 weeks until progression | — |
Secondary
| Measure | Time frame |
|---|---|
| Investigate the efficacy of AZD4547 vs paclitaxel by comparison of Overall Survival in: all randomised patients; patients with tumours that have FGFR2 amplification & patients with tumours have high FGFR2 amplification aloneTimepoint: Survival contacts, every 3 months after discontinuation of study drug until maturity of the OS endpoint;Investigate the efficacy of AZD4547 vs. paclitaxel by comparison of the change in tumour size at 8 weeks in: all randomised patients; patients with tumours that have FGFR2 amplification & patients with tumours have high FGFR2 amplification aloneTimepoint: RECIST, baseline and at week 8 | — |
Countries
Belgium, Czech Republic, France, Germany, India, Italy, Republic of Korea, Spain, Taiwan, Ukraine, United Kingdom
Contacts
Public ContactDr Ramesh Jagannathan
AstraZeneca Pharma India
Outcome results
None listed