Unknown statusInterventionalPhase 1Phase 2Last updated Mar 18, 2022

Safety and Efficacy of DCB-BO1301 in Advanced Melanoma

An Open-Label Phase I/IIa Dose-Escalation Study Evaluating the Safety, Tolerability and Efficacy of DCB-BO1301 as Add-on Therapy to Dacarbazine in Subjects With Advanced Melanoma

Overview

ClinicalTrials.gov ID: NCT02994498
Lead Sponsor: Chung Mei Biopharma Co., LtdINDUSTRY
Brief Summary: The primary study objectives are

to evaluate the safety and tolerability profiles of DCB-BO1301 and to determine the maximum tolerated dose (MTD) of DCB-BO1301 as add-on therapy to dacarbazine in subjects with advanced melanoma (Phase I)

to evaluate the efficacy profile of DCB-BO1301 at MTD or lower dose level as add-on therapy to dacarbazine in subjects with advanced melanoma in terms of progression free survival (Phase IIa)

Status

Overall Status: Unknown status
Start Date: Mar 2023Estimated
Primary Completion Date: Sep 2025Estimated
Completion Date: Dec 2025Estimated

Study Record Dates

First Submitted: Dec 9, 2016
First Submitted that Met QC Criteria: Dec 13, 2016
First Posted: Dec 16, 2016Estimated
Last Update Submitted that Met QC Criteria: Mar 17, 2022
Last Update Posted: Mar 18, 2022Actual
Last Verified: Mar 2022

NCT01227889Completed

A Study Comparing GSK2118436 to Dacarbazine (DTIC) in Previously Untreated Subjects With BRAF Mutation Positive Advanced (Stage III) or Metastatic (Stage IV) Melanoma

NCT00324155Completed

Dacarbazine and Ipilimumab vs. Dacarbazine With Placebo in Untreated Unresectable Stage III or IV Melanoma

NCT02151357Terminated

Safety, Tolerability and Pharmacokinetics of DCBCI0901 in Patients With Advanced Solid Tumor

NCT00412581Completed

Lenalidomide and Dacarbazine (DTIC) in Patients With Metastatic Melanoma

NCT00597038Completed

A Phase I/II Study of Dasatinib and Dacarbazine

NCT00496223Terminated

A Phase I/II Study of Sunitinib and Dacarbazine