This phase I trial studies the side effects and best dose of AOH1996 in treating patients with solid tumors that do not respond to treatment (refractory). AOH1996 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLT) of AOH1996. II. To establish the recommended phase 2 dose of AOH1996. III. To establish the recommended phase 2 dose of AOH1996 when given in conjunction with a TKI for NSCLC. SECONDARY OBJECTIVES: I. To determine the pharmacokinetics of AOH1996. II. To evaluate for preliminary efficacy of AOH1996. III. To evaluate response rate and disease control rate in solid tumors. EXPLORATORY OBJECTIVE: I. To determine pharmacodynamics parameters (alteration of gammaH2AX, downregulation of Myc) of AOH1996. OUTLINE: This is a dose-escalation study. Patients receive AOH1996 orally (PO) twice daily (BID) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
92
Given PO
Honor Health Research and Innovation Institute
Scottsdale, Arizona, United States
NOT_YET_RECRUITINGCity of Hope Medical Center
Duarte, California, United States
RECRUITINGIncidence of adverse events (AEs)
Toxicity and adverse events will be recorded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. All toxicities/AEs will be recorded from the initiation of protocol therapy through the follow-up period.
Time frame: Up to 30 days after last study drug is given
Dose limiting toxicities
Toxicities will be graded according to NCI CTCAE version 4.0.
Time frame: Up to 28 days (cycle 1)
Response rate
Will be assessed using Response Evaluation Criteria in Solid Tumors version 1. Response rate will be estimated in the overall population and 95% exact confidence intervals will be estimated.
Time frame: Up to 2 years
Progression-free survival
Time to disease progression/ relapse or death as a result of any cause.
Time frame: Assessed up to 2 years
Overall survival
Time to death as a result of any cause.
Time frame: Assessed up to 2 years
Time to treatment failure
Time to treatment termination for any reason (progression, toxicity, death, patient preference).
Time frame: Assessed up to 2 years
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