A Pilot Trial of Atorvastatin in Tumor Protein 53 (p53) -Mutant and p53 Wild-Type Malignancies
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|ClinicalTrials.gov Identifier: NCT03560882|
Recruitment Status : Recruiting
First Posted : June 18, 2018
Last Update Posted : July 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Malignant Disease Solid Tumor Acute Myeloid Leukemia||Drug: Atorvastatin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Trial of Atorvastatin in p53-Mutant and p53 Wild-Type Malignancies|
|Actual Study Start Date :||July 19, 2018|
|Estimated Primary Completion Date :||August 1, 2019|
|Estimated Study Completion Date :||August 1, 2020|
Atorvastatin 80 milligrams (mg) per day, orally for 1 - 4 weeks before surgery (surgery not part of clinical trial)
Atorvastatin tablet, 80mg
- Change in conformational mutant tumor protein 53 (p53) [ Time Frame: baseline and up to 4 weeks ]Measured by immunohistochemistry (IHC) staining. Reported as overall percent difference in the level of conformation mutant p53.
- Change in Ki-67 (protein) [ Time Frame: baseline and up to 4 weeks ]Measured by immunohistochemistry (IHC) staining. Reported as overall percent difference in the level of Ki-67 (also known as MKI67) in the conformation mutant p53 samples.
- Change in caspase-3 [ Time Frame: baseline and up to 4 weeks ]Measured by immunohistochemistry (IHC) staining. Reported as overall percent difference in the level of caspase-3 in the conformation mutant p53 samples.
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): NCT03560882
|Contact: Kerry Hepler, RNemail@example.com|
|United States, Kansas|
|University of Kansas Cancer Center - CRC||Recruiting|
|Fairway, Kansas, United States, 66205|
|Contact: Kerry Hepler, RN 913-945-7552 firstname.lastname@example.org|
|Principal Investigator:||Joaquina Baranda, MD||The University of Kansas Cancer Center|