Safety and Efficacy of AZD4547 Versus Paclitaxel in Advanced Gastric or Gastro-oesophageal Junction Cancer Patients (SHINE)
- Conditions
- Health Condition 1: null- Advanced Gastric or Gastro-oesophageal Junction CancerHealth Condition 2: C159- Malignant neoplasm of esophagus, unspecified
- Registration Number
- CTRI/2012/02/002432
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To investigate the efficacy of AZD4547 compared with paclitaxel by assessment of <br/ ><br>progression-free survival (PFS) in all randomised patients and also in the patients <br/ ><br>with tumours that have FGFR2 amplification (FISH score 6) aloneTimepoint: RECIST assessments will be performed at baseline and every 8 weeks until progression
- Secondary Outcome Measures
Name Time Method 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