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Clinical Trial 19742
Cancer Type: Malignant Hematology
Interventions:Minnelide
Study Type: Treatment
Phase of Study: Phase I
Investigators:
- Chetasi Talati
Call 813-745-6100 or 1-800-679-0775
Overview
Study Title
Phase 1/1b Dose Escalation Study of Minnelide in Relapsed or Refractory Acute Myeloid Leukemia
Summary
Objective
Primary Objective: · To determine the dose limiting toxicity (DLT) and maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of Minnelide monotherapy in AML.
Inclusion Criteria
Adults ages 18 years or older. Participant must have relapsed or refractory acute myeloid leukemia (AML) (excluding acute promyelocytic leukemia). Relapsed participants must have received at least 1 induction chemotherapy regimen or two cycles of a hypomethylating agent and achieved a Complete Response (CR), followed by relapse of disease. Refractory participants must have received at least 1 induction chemotherapy regimen or two cycles of hypomethylating agent without achieving a CR. Eastern Cooperative Oncology Group (ECOG) performance status >Participants must have acceptable organ function. Be able and willing to adhere to the study visit schedule and other protocol requirements. Must be able to swallow capsules and have no evidence of GI tract abnormality that would alter the absorption of oral medications. The effects of Minnelide on the developing human fetus are unknown. For this reason, women of child-bearing potential must have a negative serum or urine pregnancy test within 24 hours prior to beginning study treatment. Participants of childbearing potential must practice contraception. Females of childbearing potential: Recommendation is for 2 effective contraceptive methods during the study. Male participants with female partners who are of childbearing potential: Recommendation is for male and partner to use at least 2 effective contraceptive methods, as described above, during the study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with Minnelide, breastfeeding mothers must agree to discontinue nursing if the mother is treated with Minnelide. Participants with prior allogeneic stem cell transplant who experience relapse of AML are eligible if they are off of immunosuppressive therapy and without any evidence of graft-versus-host disease (GVHD)
Exclusion Criteria
Participants may not have received any therapy with any investigational products, systemic anti-neoplastic therapy, or radiotherapy within 14 days prior to Cycle 1 Day 1. Participants actively receiving hydroxyurea are eligible and may continue to receive hydroxyurea during protocol treatment. Candidates for standard and/or potentially curative treatments. Major surgery within 28 days prior to Cycle 1 Day 1. New York Heart Association Class III or IV heart failure, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on an electrocardiogram (EKG) Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy Known, active HIV, Hepatitis A, B or C infection (prior Hepatitis C infection that has been treated and determined to be cured is allowed) Symptomatic central nervous system (CNS) involvement with leukemia A concurrent second active and non-stable malignancy with the exception of non-melanoma skin cancer or carcinoma in-situ.
