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

• Status: Completed
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized phase II, open label, two arm study, evaluating the efficacy of panitumumab in combination with Trifluridine-Tipiracilas third line therapy, after a first line containing an anti-EGFR agent panitumumab(at least 70% of study population) or cetuximab.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Campania "Luigi Vanvitelli"
• Treatments: Panitumumab; Trifluridine

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 diagnosis

• Efficacy of a first line therapy containing an anti-EGFR agent (panitumumab or ceuximab) with a major response achieved (complete or partial response)

• Progression after a second line therapy

• Available and adequate baseline tumour tissue sample

• Measurable disease according to RECIST criteria v1.1

• Male or female patients > 18 years of age

• ECOG Performance Status 0-1

• Life expectancy of at least 3 months

• Adequate bone marrow, liver and renal function

• If female and of childbearing potential, have a negative result on a pregnancy test performed a maximum of 14 days before initiation of study treatment

• If female and of childbearing potential, or if male, agreement to use adequate contraception (eg, abstinence, intrauterine device, oral contraceptive, or double-barrier method)

• Signed informed consent

Exclusion Criteria:

• Any contraindication to use Trifluridine - Tipiracil or Panitumumab

• More than two previous lines of treatment

• 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)