Clinical Trial 18610

• Overview

  Study Title:

  A Phase I-II Study of Triciribine Phosphate Monohydrate (PTX-200) Plus Cytarabine in Refractory or Relapsed Acute Leukemia

  Summary:

  The study doctor and researchers want to find out if an investigational drug called PTX-200 can help people with AML. An investigational drug is a drug that is being tested and is not approved for sale in the United States by the U.S. Food and Drug Administration (FDA) or anywhere else in the world. The main purpose of this study is to see if investigators can select participants based on their cancer characteristics, to determine if the combination of PTX-200 with cytarabine is safe and tolerable when given together, and to determine if this combination of drugs can benefit people with AML.

  Objective:

  Objectives: Primary Objectives: To determine the safety and maximum tolerated dose (MTD) of PTX-200 given in combination with continuous-infusion cytarabine in relapsed or refractory acute leukemia or relapsed or refractory blast phase CML (Phase I). To determine clinical activity of PTX-200 + cytarabine in first relapsed AML (Phase II). Secondary Objectives: To assess the effect of PTX-200 on phospho-Akt (pAkt) signaling, proliferation and apoptosis within leukemia cells. Correlative studies to determine baseline p-Akt expression and signaling within leukemic blasts and the ability of PTX-200 to downregulate p-Akt signaling, to inhibit proliferation and induce apoptosis. Evaluate the PK of PTX-200 and TCN.

• Treatments

  Therapies:

  Chemotherapy (NOS); Therapy (NOS)

  Medications:

  Cytarabine (Cytosine Arabinoside); PTX-200 (); Triciribine Phosphate monohydrate (PTX-200)

• Inclusion Criteria

  • Pathologic confirmation of the diagnosis of AML, ALL (acute lymphoblastic leukemia), or blast-phase CML (chronic myelogenous leukemia)
  • Age ≥ 18 years
  • Eastern Cooperative Group (ECOG) Performance Status 0-2
  • Must be able to give adequate informed consent
  • Adequate organ function
  • Additional criteria may apply

• Exclusion Criteria

  • Hyperleukocytosis with ≥ 30,000 leukemic blasts/µL blood (hydroxyurea permitted up to 24 hours prior to beginning study drugs)
  • Uncontrolled Disseminated Intravascular Coagulation (DIC)
  • Uncontrolled diabetes mellitus
  • Active, uncontrolled infection
  • Additional criteria may apply

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