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Clinical Trial 19742

Cancer Type: Malignant Hematology
Study Type: Treatment
NCT#: NCT03760523

Phase: Phase I
Principal Investigator: Sweet, Kendra

Call 813-745-6100
or 1-800-679-0775 Learn More
Overview

Study Title

Phase 1/1b Dose Escalation Study of Minnelide in Relapsed or Refractory Acute Myeloid Leukemia

Summary

This study is to determine the MTD, the DLT and the recommended phase 2 dose (RP2D) of Minnelide capsules when given as a monotherapy.

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.

Treatments

Therapies

Therapy (NOS)

Medications

Minnelide ()

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 as defined per protocol.
  • Adequate cardiac function as determined by 2D echocardiogram with ejection fracture >/= 50%.
  • 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. Use of hydroxurea allowed prior to enrollment and up to the end of cycle 1 upon treatment initiation.
  • 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.

    • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.

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