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.
1. Documented informed consent by the participant
2. Willingness to permit study team to obtain and use archival tissue, if already existing
3. Age: ≥ 18 years
4. ECOG performance status ≤ 2
2. Other investigational products or chemotherapy. Exception: EGFR TKI in the NSCLC expansion cohort is allowed.
3. Warfarin
4. Current or planned use of agents contraindicated for use with strong CYP3A4 inducers
5. Strong inhibitors or inducers of CYP2C9
Single group
PCNA Inhibitor AOH1996
DrugGiven PO
Incidence 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.
Dose limiting toxicities
Toxicities will be graded according to NCI CTCAE version 4.0.
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.
Progression-free survival
Time to disease progression/ relapse or death as a result of any cause.
Overall survival
Time to death as a result of any cause.
Time to treatment failure
Time to treatment termination for any reason (progression, toxicity, death, patient preference).
Levels of plasma gammaH2AX
Will use descriptive statistics and graphical displays to summarize levels of plasma gammaH2AX, evaluate changes between pre- and post-treatment measurements. A paired t-test will be used to determine if there is a statistically significant change.
Click on the lead sponsor to view all of their trials.
City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
