EUCTR2008-001605-42-BE
Active, not recruiting
Phase 1
A Multicenter, Double-Blind, 3-Arm, Phase 1b/2 Study in Subjects with UnresectableLocally Advanced or Metastatic Gastric or Esophagogastric Junction Adenocarcinoma to Evaluate the Safety and Efficacy of First-line Treatment with Epirubicin, Cisplatin, and Capecitabine(ECX) plus AMG 102
Conditionsnrespectable locally advanced or metastatic gastric or esophagogastric unction adenocarcinomaMedDRA version: 14.1Level: PTClassification code 10063916Term: Metastatic gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- nrespectable locally advanced or metastatic gastric or esophagogastric unction adenocarcinoma
- Sponsor
- Amgen Inc
- Enrollment
- 138
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion Criteria
- •4\.1\.1 Disease related
- •Pathologically confirmed unresectable locally advanced or metastatic gastric or
- •esophagogastric junction (EGJ) adenocarcinoma; tumors of the distal esophagus
- •within 5 cm of the EGJ are eligible
- •ECOG performance status 0 or 1
- •Life expectancy \= 3 months
- •4\.1\.2 Demographic
- •Male or female \= 18 years of age
- •4\.1\.3 Ethical
Exclusion Criteria
- •Exclusion Criteria
- •4\.2\.1 Disease Related
- •Previous systemic therapy (chemotherapy or biologic therapy) for locally
- •advanced or metastatic gastric or esophagogastric adenocarcinoma
- •Less than 6 months have elapsed from completion of prior neoadjuvant or
- •adjuvant chemotherapy or chemoradiotherapy. Patients previously treated with
- •anthracyclines must not exceed total cumulative dose of epirubicin of 900 mg/m2
- •(or equivalent thereof, if a different anthracycline has been administered in the
- •past) including doses to be administered in this trial.
- •Any prior or synchronous malignancy (except for non\-melanomatous skin cancer
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Not Applicable
A Multicenter, Double-Blind, 3-Arm, Phase 1b/2 Study in Subjects with UnresectableLocally Advanced or Metastatic Gastric or Esophagogastric Junction Adenocarcinoma to Evaluate the Safety and Efficacy of First-line Treatment with Epirubicin, Cisplatin, and Capecitabine(ECX) plus AMG 102nrespectable locally advanced or metastatic gastric or esophagogastric junction adenocarcinomaEUCTR2008-001605-42-GRAmgen Inc138
Active, not recruiting
Not Applicable
A Multicenter, Double-Blind, 3-Arm, Phase 1b/2 Study in Subjects with Unresectable Locally Advanced or Metastatic Gastric or Esophagogastric Junction Adenocarcinoma to Evaluate the Safety and Efficacy of First-line Treatment with Epirubicin, Cisplatin, and Capecitabine(ECX) plus AMG 102 - 20060317Previously untreated subjects with unresectable locally advanced or metastatic gastric or esophagogastric junction adenocarcinoma.MedDRA version: 9.1Level: LLTClassification code 10051635Term: Gastrointestinal tract adenomaEUCTR2008-001605-42-ITAmgen Inc138
Active, not recruiting
Phase 1
AMG 102 Plus ECX for Unresectable Locally Advanced or Metastatic Gastric or Esophagogastric Junction Cancernrespectable locally advanced or metastatic gastric or esophagogastric unction adenocarcinomaMedDRA version: 14.1 Level: LLT Classification code 10017759 Term: Gastric cancer in situ System Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2008-001605-42-GBAmgen Inc138
Active, not recruiting
Not Applicable
A Multicenter, Double-Blind, 3-Arm, Phase 1b/2 Study in Subjects with UnresectableLocally Advanced or Metastatic Gastric or Esophagogastric Junction Adenocarcinoma to Evaluate the Safety and Efficacy of First-line Treatment with Epirubicin, Cisplatin, and Capecitabine(ECX) plus AMG 102.-----------------------------------------------------------Estudio multicéntrico, a doble ciego, de 3 brazos y de fases 1b/2 en sujetos con adenocarcinoma gástrico o de la unión gastroesofágica metastásico o localmente avanzado no resecable para evaluar la seguridad y la eficacia del tratamiento de primera línea con epirubicina, cisplatino y capecitabina (ECX) junto con AMG 102.nrespectable locally advanced or metastatic gastric or esophagogastric unction adenocarcinoma.-----------------------------------------------------------Sujetos con adenocarcinoma gástrico o de la unión gastroesofágica metastásico o localmente avanzado no resecable, no tratados previamenteEUCTR2008-001605-42-ESAmgen Inc138
Active, not recruiting
Not Applicable
A Multicenter, Double-Blind, 3-Arm, Phase 1b/2 Study in Subjects with UnresectableLocally Advanced or Metastatic Gastric or Esophagogastric Junction Adenocarcinoma to Evaluate the Safety and Efficacy of First-line Treatment with Epirubicin, Cisplatin, and Capecitabine(ECX) plus AMG 102nrespectable locally advanced or metastatic gastric or esophagogastric unction adenocarcinomaMedDRA version: 12.1Level: LLTClassification code 10063916Term: Metastatic gastric cancerEUCTR2008-001605-42-HUAmgen Inc138