A Pilot Trial of Atorvastatin in Tumor Protein 53 (p53) -Mutant and p53 Wild-Type Malignancies (NCT03560882) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Pilot Trial of Atorvastatin in Tumor Protein 53 (p53) -Mutant and p53 Wild-Type Malignancies
United States50 participantsStarted 2018-07-19
Plain-language summary
This is a window-of-opportunity trial to determine if atorvastatin given for 1 to 4 weeks at a dose of 80 milligrams per day (mg/day) is sufficient to decrease the level of conformational mutant tumor protein 53 (p53) in malignant diseases (solid tumor and relapsed Acute Myeloid Leukemia (AML)).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Ability of participant to understand this study, and participant to sign a written informed consent. Legally authorized representative is not allowed to sign consent for participant.
* Participants with tumor protein 53 (TP53) immunohistochemistry (IHC)-positive tumors
* Participants whose screening IHC shows TP53-IHC-negative including wild type (WT) and null.
* Participants with histologic or cytologic confirmation of any malignant disease who are planning and eligible to undergo surgical resection. For participants with Solid Tumors Only
* Participants with previously treated acute myeloid leukemia (AML) are eligible if they relapse and are in between two treatment regimens
* No concurrent or recent (within 30 days) use of systemic therapy including chemotherapy, immunotherapy, hormonal therapy, cancer vaccine, or local therapy for the cancer.
* Formalin-fixed paraffin-embedded (FFPE) tumor tissue deemed adequate for IHC analysis and next generation sequencing (NGS) are required. Bone marrow aspirate tissue samples from participants with AML are required.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Adequate organ and marrow function
* A negative urine or serum pregnancy test within 7 days before Day 1 dose of study medication, if female participant is of childbearing potential.
* Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence, or to use two form…
What they're measuring
1
Change in conformational mutant tumor protein 53 (p53)