A Phase 1 Study of AOH1996 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCity of Hope Medical Center
About this trial
This phase 1 trial tests safety, side effects, and best dose of AOH1996 for the treatment of patients with acute myeloid leukemia (AML) that has come back after a period of improvement (relapsed) or AML that has not responded to previous treatment (refractory). AOH1996 is in a class of medications called PCNA inhibitors. It inhibits cancer growth and induces deoxyribonucleic acid (DNA) damage. This may help keep cancer cells from growing and damage cancer cell DNA. Giving AOH1996 may be safe, tolerable and/or effective in treating patients with AML.
Eligibility criteria
Qualifiers
Documented informed consent of the participant and/or legally authorized representative
Age: ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) ≤ 2
Life expectancy > 3 months
Disqualifiers
Hematopoietic stem cell transplant within 100 days prior to day 1 of protocol therapy. Patients who have stopped calcineurin inhibitors (CNI) must be off CNIs for at least 2 weeks prior to day 1 of protocol therapy
Chemotherapy, radiation therapy, biological therapy, immunotherapy within 14 days prior to day 1 of protocol therapy with the following exception of hydroxyurea which is allowed prior to treatment and through cycle 1 for control of rapidly progressing leukemia
Strong inducers or strong inhibitors of CYP enzymes (e.g., 1A2, 2B6, 2C8, 2C9, 2C19, and 3A4), other than azole antifungals with CYP3A4 inhibition potential, or drug transporters (e.g., organic anions [OATP1B1/1B3], BCRP, P-gp, organic cations [OCT1, OCT2, OCT3], MATE1 or MATE2K), or sensitive substrates of these CYPs or drug transporters, within 4-5 half-lives or 14 days prior to the first dose of study drug, whichever is longer.
Foods/supplements that are strong inhibitors or strong or moderate inducers of CYP3A (such as St. John's wort) within 3 days prior to initiation of and during study treatment
Trial design
Treatments tested in this trial
- Azacitidine
- Biospecimen Collection
- Bone Marrow Aspiration
- PCNA Inhibitor AOH1996
- Venetoclax
Treatment groups
12 Participants
are divided into 1 treatment groupSponsors and collaborators
City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov