A Two Part Study in Japanese Patients With mCRC, Consisting of an Open-Label Phase I Part to Assess the Safety and Tolerability of AZD2171 in Combination With FOLFOX Followed by a Phase II, Randomised, Double-Blind, Parallel Group Study to Assess the Efficacy of AZD2171 in Combination With FOLFOX

Authors
Category Primary study
Registry of TrialsJapan Primary Registry Network
Year 2007
INTERVENTION: investigational material(s) Generic name etc : AZD2171 INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Oral CONDITION: Metastatic Colorectal Cancer PRIMARY OUTCOME: Efficacy Primary Outcome Measures:‐ Progression of Metastatic Colorectal Cancer (mCRC) ‐ PFS Secondary Outcome Measures: ‐ Safety and tolerability [Time Frame: assessed at each visit] INCLUSION CRITERIA: Ages Eligible for Study: 18 Years and above Genders Eligible for Study: Both INCLUSION CRITERIA: ‐ Metastatic colorectal cancer ‐ WHO performance status 0‐1 ‐ Life expectancy is 12 weeks or longer Exclusion Criteria: ‐ Patient with uncontrolled brain metastases ‐ Patient with inappropriate laboratory tests values ‐ Patient with poorly controlled hypertension
Epistemonikos ID: ce948342a7e07efe3d229e27ff68536c0dc1be28
First added on: Aug 26, 2024