Suspended

PACERA Phase 2 Study of Panitumumab in Patients With Cetuximab-refractory Metastatic Colorectal Cancer

What is being tested

Panitumumab

Drug

Who is being recruted

Colonic Diseases+8

+ Digestive System Diseases

+ Digestive System Neoplasms

Over 18 Years

+19 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2

Interventional

Study Start: December 2012

See protocol details

Summary

Principal SponsorNational Cancer Institute, Naples

Last updated: March 24, 2023

Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2012

Actual date on which the first participant was enrolled.

The study was amended with modification of inclusion criteria (from wild-type tumor KRAS gene to wild-type RAS gene, including KRAS and NRAS exons 2, 3 and 4) RAS mutational status of tumors of patients enrolled before amendment 1 approval will be centrally revised. Patients whose tumors will result RAS mutated at the biomarkers central revision, will be replaced. Therefore, the overall sample size at both the stages may be higher than the one initially planned.

NCT01801904

Principal SponsorNational Cancer Institute, Naples

Last updated: March 24, 2023

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

52 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Colonic DiseasesDigestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsIntestinal DiseasesIntestinal NeoplasmsNeoplasmsNeoplasms by SiteRectal DiseasesColorectal Neoplasms

Criteria

13 inclusion criteria required to participate

AST (SGOT) and ALT (SGPT) not greater than 2.5 times ULN (or 5 times ULN in presence of liver metastasis)

Age at least 18 years

Bilirubin level less than 1.5 times ULN

Documented disease progression following a treatment with cetuximab in patients who showed either an objective response after 8 weeks or stable disease after 16 weeks of cetuximab treatment

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6 exclusion criteria prevent from participating

Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or non melanoma skin cancer)

Any unstable systemic disease (including active infections, any significant hepatic, renal or metabolic disease), metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of study drugs or render the patient at high risk from treatment complications

Chemotherapy, radiotherapy or immunotherapy within the past 4 weeks

Interstitial pneumonitis or pulmonary fibrosis

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 5 locations

Azienda Ospedaliera G. Rummo

Benevento, ItalyOpen Azienda Ospedaliera G. Rummo in Google Maps

Ospedale Fatebenefratelli

Benevento, Italy

A.O.U. Policlinico Federico II

Naples, Italy

Istituto Nazionale dei Tumori

Naples, Italy

Suspended5 Study Centers