Trials Sponsors Conditions Drugs Pricing

Conditions

Head and Neck Neoplasms Solid Tumors

Keywords

Solid tumorsHead and Neck Neoplasms

Outcome Measures

Primary Outcomes (2)

The maximum-tolerated dose (MTD) of DTP348 as single agent
To assess the safety and tolerability of DTP348 when administered orally as single agent in patients with advanced solid tumours in order to determine the Maximum Tolerated Dose (MTD) in relation with the occurrence of a Dose Limiting Toxicity (DLT).
3 months
The maximum-tolerated dose (MTD) regimen of DTP348 as single agent in combination with radiotherapy
To assess the safety and tolerability of DTP348 when administered orally in combination with radiotherapy in patients with HNSCC and to determine the Recommended Phase II Dose (RP2D) of this treatment combination.
3 months

Secondary Outcomes (3)

Plasma concentration of DTP348
3 months
Response rate according to RECIST, version 1.1, DTP348 monotherapy
3 months
Response rate according to RECIST version 1.1, DTP348 in combination of radiotherapy
3 months

Study Arms (1)

DTP348

EXPERIMENTAL

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

Drug: DTP348

Interventions

DTP348Drug

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

Also known as: 2-(2-methyl-5-nitro-1H-imidazol-1-yl)ethylsulfamide

DTP348

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients with histologically or cytologically confirmed solid malignancy that is metastatic or unresectable and for which standard curative measures or other therapy that may provide clinical benefit do not exist or are no longer effective.
Age 18 year or older

Sponsors & Collaborators

Maastricht Radiation Oncology
Otherlead

Study Sites (1)

Maastro Clinic

Maastricht, Limburg, 6229 ET, Netherlands

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

Frank Hoebers, Dr.
Maastro Clinic, The Netherlands
PRINCIPAL INVESTIGATOR

Enrollment

0 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 8, 2014

First Posted

August 15, 2014

Study Start

March 2017

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Study Arms (1)

DTP348

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Study Arms (1)

DTP348

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations