CI

At a glance

ClinicalIndex Comparison Record
Phase 2Unknown· 12 enrolled
Drug / intervention
Panitumumab +4 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03992456
NCT03992456Phase 2Unknown

PULSE: A Randomized, Phase II Open Label Study of PanitUmumab RechaLlenge Versus Standard Therapy After Progression on Anti-EGFR Therapy in Patients With Metastatic and/or Unresectable RAS Wild-Type Colorectal Cancer

Academic and Community Cancer Research United·interventional·Posted Jun 20, 2019·Updated May 21, 2024

In Brief

A Phase 2 clinical trial evaluating Panitumumab, Quality-of-Life Assessment, and 3 other interventions for Metastatic Colon Adenocarcinoma and 29 related conditions. Targeting 12 participants across 18 sites.

Detailed Summary

This phase II trial studies how well retreatment with panitumumab works compared to standard of care regorafenib or trifluridine and tipiracil hydrochloride (TAS-102) in treating patients with colorectal cancer that is negative for RAS wild-type colorectal cancer has spread to other places in the body (metastatic), and/or cannot be removed by surgery (unresectable), and is negative for resistance mutations in blood. Treatment with panitumumab may interfere with the ability of tumor cells to grow and spread. Some tumors need growth factors to keep growing. Growth factor antagonists, such as regorafenib, may interfere with the growth factor and stop the tumor from growing. Drugs used in chemotherapy, such as TAS-102, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving panitumumab may work better in treating patients with colorectal cancer than with the usual treatment of regorafenib or TAS-102.

Study Details

Timeline

Phase 2UnknownOverdue
2020202120222023202420252026
First PostedJun 20, 2019
Enrollment StartApr 24, 2020
Primary CompletionDec 1, 2023
Study CompletionOct 7, 2024
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 7.0 years ago

Interventions

Panitumumabbiological

Given IV

Quality-of-Life Assessmentother

Ancillary studies

Questionnaire Administrationother

Ancillary studies

Regorafenibdrug

Given PO

Trifluridine and Tipiracil Hydrochloridedrug

Given PO