mCRC MedDRA version: 20.0 Level: HLGT Classification code 10017991 Term: Gastrointestinal neoplasms malignant and unspecified System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: VECTIBIX - 20 MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO 1 FLACONCINO (VETRO) 20 ML
Product Name: VECTIBIX
Product Code: [VECTIBIX]
Pharmaceutical Form: Concentrate for
Sponsors
Dipartimento di Medicina di Precisione - Università degli studi della Campania "L. Vanvitelli"
Eligibility
Sex/Gender
All
Inclusion 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 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 66 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 66
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Compare the activity of panitumumab in combination with Trifluridine-Tipiracile vs standard third line therapy (Trifluridine-Tipiracile) as measured by ORR Compare the efficacy of panitumumab in combination with Trifluridine-Tipiracile vs standard third line therapy (Trifluridine-Tipiracile) as measured by OS Asses the safety and tolerability of panitumumab in combination with Trifluridine-Tipiracile vs standard third line therapy (Trifluridine-Tipiracile);Main Objective: Assess the efficacy of panitumumab in combination with Trifluridine- Tipiracile vs standard third line therapy (Trifluridine-Tipiracile) as measured by PFS;Primary end point(s): PFS: defined as the time from randomization to the earliest documented disease progression or death due to any cause;Timepoint(s) of evaluation of this end point: All subjects will be followed until death and data on subsequent treatment will be collected. Follow-up information on tumor status and vital status will be updated every 3 months until death | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • ORR: per the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 (v1.1), defined as the number of patients achieving an overall best response of complete or partial response divided by the total number of patients • OS: defined as the time from randomization to death due to any cause of panitumumab in combination with Trifluridine-Tipiracile vs Trifluridine-Tipiracile • Safety analysis: defined as the evaluation of incidence and severity of Adverse Events (AEs);Timepoint(s) of evaluation of this end point: All subjects will be followed until death and data on subsequent treatment will be collected. Follow-up information on tumor status and vital status will be updated every 3 months until death | — |
Countries
Italy
Contacts
Public ContactUOC Oncoematologia
Dipartimento di Medicina di Precisione - Università degli Studi della Campania "Luigi Vanvitelli"
Outcome results
None listed