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临床试验/CTRI/2012/02/002432
CTRI/2012/02/002432已完成2 期

A Randomised Open-Label Phase II Study to Assess the Efficacy and Safety of AZD4547 Monotherapy versus Paclitaxel in Patients with Advanced Gastric Adenocarcinoma (including Adenocarcinoma of the Lower Third of the Oesophagus or the Gastro-Oesophageal Junction) with FGFR2Polysomy or Gene Amplification (Shine study) - SHINE

AstraZeneca AB0 个研究点目标入组 1 人开始时间: 待定最近更新:
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试验速览

阶段
2 期
状态
已完成
入组人数
1
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • •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.

排除标准

  • •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.

研究者

相似试验

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Efficacy and safety of AZD4547 versus paclitaxel in Advanced Gastric or Gastro-oesophageal Junction Cancer patients
EUCTR2010-023377-19-BEAstraZeneca240
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Efficacy and safety of AZD4547 versus paclitaxel in Advanced Gastric or Gastro-oesophageal Junction Cancer patientsFGFR, Amplification, polysomy, gastro-oesophageal junction cancer, lower third oesophageal cancer, gastric cancer, randomised, efficacyMedDRA version: 14.1Level: PTClassification code 10017758Term: Gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10063916Term: Metastatic gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10017761Term: Gastric cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10061967Term: Gastric cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10030159Term: Oesophageal carcinoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10017765Term: Gastric cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: LLTClassification code 10026104Term: Malignant neoplasm of lower third of esophagusSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10030155Term: Oesophageal carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
EUCTR2010-023377-19-BGAstraZeneca240
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Efficacy and safety of AZD4547 versus paclitaxel in Advanced Gastric or Gastro-oesophageal Junction Cancer patientsFGFR, Amplification, polysomy, gastro-oesophageal junction cancer,lower third oesophageal cancer, gastric cancer, randomised, efficacyMedDRA version: 14.1Level: PTClassification code 10017758Term: Gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10063916Term: Metastatic gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10017761Term: Gastric cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10061967Term: Gastric cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10030159Term: Oesophageal carcinoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10017765Term: Gastric cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: LLTClassification code 10026104Term: Malignant neoplasm of lower third of esophagusSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10030155Term: Oesophageal carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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Safety and efficacy of AZD4547 versus paclitaxel in Advanced Gastric or Gastro-oesophageal Junction Cancer patientsFGFR, Amplification, polysomy, gastro-oesophageal junction cancer, lower third oesophageal cancer, gastric cancer, randomised, efficacyMedDRA version: 14.1Level: PTClassification code 10017758Term: Gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10063916Term: Metastatic gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10017761Term: Gastric cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10061967Term: Gastric cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10030159Term: Oesophageal carcinoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10017765Term: Gastric cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: LLTClassification code 10026104Term: Malignant neoplasm of lower third of esophagusSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10030155Term: Oesophageal carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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