Regorafenib, C-kit Mutated Malignant Melanoma, 2nd Line Therapy

NCT02501551 | Unknown Phase 2

• 1 other identifier: 4-2014-0573
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase II trial of regorafenib in patients with metastatic melanoma harboring c-Kit mutations and/or amplifications of c-Kit gene copy number. The primary end point is disease control rate (DCR), and the secondary end points are safety, response rate (RR), progression free survival (PFS), and overall survival (OS).

Conditions

Melanoma

Keywords

Malignant melanoma; C-KIT mutation

Outcome Measures

Primary Outcomes (1)

• disease control rate as measured by RECIST 1.1

  at 8 weeks

Study Arms (1)

Regorafenib

EXPERIMENTAL

160mg regorafenib once daily with a low fat breakfast for the first 21 days of each 28-day cycle

Drug: regorafenib

Interventions

regorafenib DRUG

160mg regorafenib once daily with a low fat breakfast for the first 21 days of each 28-day cycle

Regorafenib

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically proven melanoma with stage IV or unresectable stage III disease
• c-kit mutations
• performance status of 0, 1, and 2
• Have progressed after 1 previous systemic treatment containing dacarbazine, temozolomide, or immunotherapy for metastatic melanoma
• Patients with central nervous system metastasis must have stable neurologic function without evidence of central nervous system progression within 8 weeks
• Measurable disease or non-measurable but evaluable disease, according to the Response Evaluation Criteria in Solid Tumors v1.1

You may not qualify if:

• Major surgery or radiation therapy within 4 weeks of starting the study treatment
• History of or known carcinomatous meningitis, or evidence of symptomatic leptomeningeal disease
• Have received greater than or equal to 2 previous chemotherapy-containing systemic treatment regimens
• Patients with BRAF or NRAS mutation
• Prior therapy with a c-kit inhibitor
• Significant history of cardiac disease, myocardial infarction, or current cardiac ventricular arrhythmias requiring medication
• Major surgery within 4 weeks before start of study treatment
• Active gastrointestinal bleeding
• Patients treated with co-administration of a strong CYP3A4 inducers
• Adequate Hematologic, Biochemical, and Organ Function

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital, Yonsei University Health System

Seoul, 120-752, South Korea

RECRUITING

MeSH Terms

Conditions

Melanoma

Interventions

regorafenib

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Sang Joon Shin

CONTACT

02-2228-8138

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 5, 2015
• First Posted: July 17, 2015
• Study Start: February 1, 2015
• Primary Completion: May 1, 2022
• Study Completion: June 1, 2022
• Last Updated: April 5, 2021

Record last verified: 2021-04

Locations

KR (1)