MedTrace Logo

A Study of Maprotiline in Combination With Tamoxifen and Temozolomide for Recurrent Glioblastoma

NCT04200066 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2022-08-22

No results posted yet for this study

Summary

The main purpose of this study is to find out the highest possible dose of maprotiline that can be given safely in combination with temozolomide and tamoxifen.

Conditions

Interventions

DRUG

Temozolomide, Tamoxifen, Maprotiline

Subjects will receive a combination of temozolomide and tamoxifen for two weeks. After that, they will receive a combination of temozolomide, tamoxifen and maprotiline for the remainder of the study. All drugs are administered orally. Subjects will undergo visits at the beginning of week 3, week 5 and week 7 that will involve multiple blood draws and ECGs to evaluate for pharmacokinetics and drug interactions. Response will be assessed every two months with an MRI and patients will continue on study as long as their tumors are under control and they are tolerating the regimen.

Sponsors & Collaborators

  • University of Rochester

    lead OTHER

Principal Investigators

  • Nimish Mohile, MD · University of Rochester

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2023-10-01
Completion
2024-02-01
FDA Drug
Yes

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 NCT04200066 on ClinicalTrials.gov