EUCTR2008-005301-19-ES
Active, not recruiting
Phase 1
Estudio de fase 2, aleatorizado, a doble ciego y controlado con placebo para evaluar la seguridad y eficacia de FOLFIRI en combinación con AMG 479 o AMG 655 en comparación con FOLFIRI en el tratamiento de segunda línea del carcinoma colorrectal metastásico con KRAS mutado.A Phase 2, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safetyand Efficacy of FOLFIRI in Combination With AMG 479 or AMG 655 Versus FOLFIRI for the Second-line Treatment of KRAS-mutant Metastatic Colorectal Carcinoma
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Amgen Inc
- Enrollment
- 150
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Disease Related
- •? Histologically confirmed adenocarcinoma of the colon or rectum in patients with
- •metastatic disease
- •? Mutant\-type KRAS tumor status confirmed by central laboratory assessment of
- •formalin\-fixed paraffin\-embedded tumor tissue from the primary tumor or metastasis
- •? One and only one prior anti\-cancer therapy regimen for metastatic disease
- •consisting of the combination of a fluoropyrimidine and oxaliplatin\-based
- •chemotherapy with or without anti\-VEGF therapy. Prior adjuvant or neoadjuvant
- •chemotherapy used prior to the onset of metastatic disease is permitted.
- •? Documented disease progression while receiving or ? 6 months after the last dose of prior first\-line fluoropyrimidine and oxaliplatin\-based chemotherapy with or without
Exclusion Criteria
- •Disease Related
- •? History or known presence of central nervous system (CNS) metastases
- •? History of other malignancy, except:
- •? Malignancy treated with curative intent and with no known active disease present
- •for ? 3 years prior to randomization and felt to be at low risk for recurrence by the
- •treating physician
- •? Adequately treated non\-melanomatous skin cancer or lentigo maligna without
- •evidence of disease
- •? Adequately treated cervical carcinoma in situ without evidence of disease
- •? Prostatic intraepithelial neoplasia without evidence of prostate cancer
Outcomes
Primary Outcomes
Not specified
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