Dose-Seeking Study of MPT0E028 in Subjects With Advanced Solid Malignancies Without Standard Treatment

Advanced Solid Malignancies Clinical Trial

Official title: A Phase 1, First-In-Human, Dose-Seeking Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of Orally Administered MPT0E028 in Subjects With Advanced Solid Malignancies Without Standard Treatment

Status Completed

Clinical Trial Summary

The Dose Escalation Phase will determine the MTD of MPT0E028 and evaluate its safety and tolerability, PK, PD, and preliminary clinical effects; the subsequent Dose Confirmation Phase will be a cohort expansion at or below the MTD (i.e., an RP2D) of MPT0E028.

Clinical Trial Description

This is an open-label, non-randomized, dose-escalation study that will evaluate MPT0E028 in subjects with advanced solid malignancies. Subjects will be treated with oral doses of MPT0E028 in consecutive, 28-day cycles, and will be evaluated regularly for safety. Subjects who tolerate the drug and who do not experience progressive disease may continue to receive MPT0E028 at the discretion of the principal Investigator for up to 6 cycles. The Sponsor will keep providing drug for extension cycles to subjects whose disease is controlled at the end of 6th cycle until the end of the study or until the early study termination determined by sponsor. Subjects will return for a follow-up visit 28 days after completion of the end of Study. ;

Related Conditions & MeSH terms

• Advanced Solid Malignancies
• Neoplasms

• NCT number: NCT02350868
• Study type: Interventional
• Source: Taipei Medical University
• Status: Completed
• Phase: Phase 1
• Start date: April 24, 2015
• Completion date: January 19, 2019