Study of Letrozole in Recurrent Gliomas
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|ClinicalTrials.gov Identifier: NCT03122197|
Recruitment Status : Recruiting
First Posted : April 20, 2017
Last Update Posted : October 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Brain Tumor||Drug: Letrozole Oral Tablet||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||A Phase 0/1 Exploratory Pharmacokinetic and Pharmacodynamics Study of Letrozole in Recurrent Gliomas|
|Actual Study Start Date :||May 16, 2017|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||June 2019|
Letrozole doses range includes 2.5, 3, 6, 9, and 12 mg daily.
Drug: Letrozole Oral Tablet
Daily treatment 1-5 days preop and resuming post op
- Overall Letrozole AUC in tumor tissue. [ Time Frame: 5 days ]Pharmacokinetic modeling will be used to determine the overall AUC in the tumor tissue to assess for letrozole penetration through blood brain barrier.
- Adverse Events [ Time Frame: The time patients remain on treatment until 30 days after treatment completed ]The number of patients with treatment related toxicity will be assessed using CTCAE v4.0
- Progression free Survival [ Time Frame: From start of treatment until time of progression assessed up to 1 year ]Patients will be followed for response using RANO criteria to determine time from start of treatment to progression.
- Overall Survival [ Time Frame: From start of treatment until time of death assessed up to 1 year ]Patients will be followed from start of treatment until time of death
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03122197
|Contact: UC Cancer Institute Clinical Trials Officefirstname.lastname@example.org|
|United States, Ohio|
|University of Cincinnati||Recruiting|
|Cincinnati, Ohio, United States, 45267|
|Contact: Trisha Wise-Draper, MD, PhD|
|Principal Investigator:||Trisha Wise-Draper, MD||University of Cincinnati|