Spots Global Cancer Trial Database for A Phase 2 Study of Panitumumab in Patients With Cetuximab-refractory Metastatic Colorectal Cancer

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: A Phase 2 Study of Panitumumab in Patients With Cetuximab-refractory Metastatic Colorectal Cancer

Official Title: A Phase 2 Study of Panitumumab in Patients With Cetuximab-refractory Metastatic Colorectal Cancer

Study ID: NCT01801904

Conditions

Metastatic Colorectal Cancer

Interventions

Panitumumab

Study Description

Brief Summary: The purpose of this study is to assess if panitumumab is active enough to warrant comparative studies in patients with metastatic colorectal cancer that has progressed after treatment with cetuximab.

Detailed Description: 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.

Keywords

cetuximab-refractory

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Azienda Ospedaliera G. Rummo, Benevento, BN, Italy

Ospedale Fatebenefratelli, Benevento, , Italy

A.O.U. Policlinico Federico II, Napoli, , Italy

Istituto Nazionale dei Tumori, Napoli, , Italy

Casa Sollievo Sofferenza, S. Giovanni Rotondo, , Italy