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Trial to Determine Optimal Phase II Dose of the Oral Dual CAIX Inhibitor/ Radiosensitizer

NCT02216669 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2017-03-03

No results posted yet for this study

Summary

This is a Phase I multicenter, open-label, dose-escalation study of DTP348. DTP 348 is an oral dual drug with two mechanisms of action:

1. carbonic anhydrase IX inhibitor which acidifies the intracellular pH through the sulfamide components
2. radio sensitizer of hypoxic cells through its 5-nitroimidazole moiety

The study will be conducted in 2 parts. The phase I trials will be on the standard 3+3 design first as single agent then combined with radiotherapy:

1. A single agent dose-escalation phase in patients with solid tumours.
2. A dose-escalation phase in patients with HNSCC in combination with radiotherapy

The main objective is to determine the recommended phase II dose of DTP348 in combination with radiotherapy

Conditions

Interventions

DRUG

DTP348

Patients will receive a continuous oral dose of DTP348 for 7 days per week for 7 weeks

Sponsors & Collaborators

  • Maastricht Radiation Oncology

    lead OTHER

Principal Investigators

  • Frank Hoebers, Dr. · Maastro Clinic, The Netherlands

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-31
Primary Completion
2017-06-30
Completion
2017-07-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02216669 on ClinicalTrials.gov