Phase II study of Panitunumab plus Cetuximab in pretreated in patients with metastatic colorectal cancer

Phase 1

• Conditions: mCRC; MedDRA version: 20.0Level: HLGTClassification code 10017991Term: Gastrointestinal neoplasms malignant and unspecifiedSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-001600-12-IT
• Lead Sponsor: Dipartimento di Medicina di Precisione - Università degli studi della Campania L. Vanvitelli

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-20
• Last Update Posted: 7 September 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 112

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

• 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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified