EUCTR2018-001600-12-IT
Active, not recruiting
Phase 1
Phase II randomized study evaluating the efficacy of panitumumab (VEctibix) and Trifluridine-Tipiracil (LOnsurf) in pretreated RAS wild type metastatic colorectal cancer patients: the VELO trial - VELO
Dipartimento di Medicina di Precisione - Università degli studi della Campania L. Vanvitelli0 sites112 target enrollmentMay 20, 2021
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- mCRC
- Sponsor
- Dipartimento di Medicina di Precisione - Università degli studi della Campania L. Vanvitelli
- Enrollment
- 112
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically proven diagnosis of colorectal adenocarcinoma
- •Diagnosis of metastatic disease
- •RAS (NRAS and KRAS exon 2,3 and 4\) wild\-type in tissue at initial
- •Efficacy of a first line therapy containing an anti\-EGFR agent
- •(panitumumab or cetuximab) with a major response achieved (complete
- •or partial response)
- •A second line therapy
- •More than 4 months from last dose of anti\-EGFR agent administered
- •in first line treatment before randomization.
- •ECOG Performance Status 0\-1
Exclusion Criteria
- •Any contraindication to use Trifluridine \- Tipiracile or Panitumumab
- •Active uncontrolled infections
- •Past or current history of malignancies other than colorectal carcinoma, except for curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix
- •Pregnancy
- •Breastfeeding
- •Interstitial lung disease or pulmonary fibrosis
- •Grade III or IV heart failure (NYHA classification)
Outcomes
Primary Outcomes
Not specified
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