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Study of Induction of Hypothyroxinemia Adjunct to Conventional Therapies in GBM Patients | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Study of Induction of Hypothyroxinemia Adjunct to Conventional Therapies in GBM Patients

Phase II, Open-label, Prospective, Single-arm, Single-center Study of Induction of Hypothyroxinemia Adjunct to Conventional Therapies in GBM Patients

NCT02654041•Musli Thyropeutics Ltd.

View on ClinicalTrials.gov

Summary

The objective of the study is to assess the safety and efficacy of treatment with hypothyroxinemia adjunct to conventional therapies in GBM patients.

Detailed Description

Since T4 (thyroxine) is a potent growth factor in numerous cancer types, the interventional approach will be to achieve thyroxine deprivation (hypothyroxinemia).This can be achieved by using a dual approach: T3 and methimazole to provide longer term inhibition of thyroid hormone synthesis.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosis of GBM, histologically or cytologically confirmed.
•Newly-diagnosed subjects prior to beginning first-line conventional therapy.
•Male or female subjects 18 years of age or older.
•Ability to understand and willingness to sign a written informed consent document.
•Ability and consent to comply with completion of a patient diary.
•Subjects must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) with conventional techniques or as ≥10 mm (≥1 cm) with spiral CT scan, MRI, or calipers by clinical exam.
•Allowable type and amount of prior therapy and medication
•ECOG performance status ≤2 (KPS ≥60%, see Appendix A).
•Life expectancy of greater than 6 months
•Subjects must have adequate bone marrow, liver and renal function as assessed by the following laboratory requirements conducted within 7 days of starting to study treatment:
+11 more criteria

Exclusion Criteria

•Patients unable to swallow oral medications.
•Patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
•Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study medication.
•Patients who are receiving any other investigational agents or participating in another interventional clinical trial within 30 days prior to baseline visit (patients participating in other observational trials are allowed to be enrolled in this study).
•History of allergic reactions attributed to compounds of similar chemical or biologic composition to anti-thyroid agent (such as methimazole or PTU) or Cytomel®, or other agents used in study.
•Current or prior (within the last 60 days prior to screening visit) use of any medication or substance that have the potential to affect the activity or pharmacokinetics of the study agents (please refer to package inserts of study drugs).
•Specific none-allowable type and amount of prior therapy and medication
•Clinically significant concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, active connective tissue disorders, such as lupus or scleroderma, human immunodeficiency virus or psychiatric illness/social situations that in the opinion of the investigator, could interfere with the safety, compliance or other aspects of this study and would limit compliance with study requirements.
•History of organ allograft.
•Non-healing wound, ulcer, or bone fracture.
+7 more criteria

Locations (1)

Tel-Aviv Medical Center, Israel

Tel Aviv, Israel

Key Dates

Start Date

March 1, 2016

Primary Completion Date

June 1, 2017

Completion Date

June 1, 2017

Last Updated

March 22, 2018

Enrollment

ACTUAL participants

Conditions

Glioblastoma Multiforme (GBM)

Interventions

Combined T3 and Methimazole treatment

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 22, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of Induction of Hypothyroxinemia Adjunct to Conventional Therapies in GBM Patients

Inclusion Criteria

Exclusion Criteria

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