Clinical Trials /

A Study of PTX-200 (Triciribine) Plus Cytarabine in Refractory or Relapsed Acute Leukemia

NCT02930109

Description:

A phase I-II open label study of PTX-200 in combination with cytarabine in the treatment of relapsed or refractory acute leukemia.

Related Conditions:
  • Acute Lymphoblastic Leukemia
  • Acute Myeloid Leukemia
  • Chronic Myeloid Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

URL:

https://clinicaltrials.gov/show/NCT02930109

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: PTX-200-AML-015
  • NCT ID: NCT02930109

Conditions

  • Acute Leukemia

Interventions

DrugSynonymsArms
PTX-200Triciribine Phosphate MonohydratePTX-200 and cytarabine
CytarabineAra-CPTX-200 and cytarabine

Purpose

A phase I-II open label study of PTX-200 in combination with cytarabine in the treatment of relapsed or refractory acute leukemia.

Detailed Description

      Study design: Phase I/II study The Phase I study is open-label with four increasing dose
      levels for up to four 21-day cycles. Safety and activity will be evaluated at the end of each
      cycle.

      The Phase II study is open label with administration of the recommended phase dose of PTX-200
      for up to four 21-day cycles. PTX-200 will be co-administered with cytarabine in both the
      Phase I and Phase II parts of the study.

Trial Arms

NameTypeDescriptionInterventions
PTX-200 and cytarabineExperimentalPTX-200 administered intravenously over 1 hour Phase I: 4 dose levels: 25 to 55 mg/m2 (with reduction to 15 mg/m2 if needed. Phase II: maximum tolerated dose. given as a 1 hour infusion Cytarabine administered by continuous infusion at a dose of 400 mg/m2/day for 4 days.
  • PTX-200
  • Cytarabine

Eligibility Criteria

        Inclusion Criteria:

          -  Pathologic confirmation of the diagnosis of AML, ALL (acute lymphoblastic leukemia),
             or blast-phase CML (chronic myelogenous leukemia)

          -  Age ≥ 18 years

          -  ECOG Performance Status 0-2

          -  Patients must be able to give adequate informed consent

        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
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Treatment-related Adverse Events
Time Frame:12 months
Safety Issue:
Description:Number of participants with treatment-related Adverse Events as assessed by CTCAE v4.0 that result in dose-limitations (Phase I)

Secondary Outcome Measures

Measure:Phospho-Akt (pAkt) expression within CD34+ leukemic blasts
Time Frame:12 months
Safety Issue:
Description:Change from baseline phospho-Akt (pAkt) signaling within CD34+ leukemic blasts and the ability of PTX-200 to downregulate p-Akt and its signaling at a variety of times

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Prescient Therapeutics, Ltd.

Last Updated

February 9, 2021