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

April 3, 2024 updated by: Prescient Therapeutics, Ltd.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center
    • Kansas
      • Fairway, Kansas, United States, 60069
        • University of Kansas Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PTX-200 and cytarabine

PTX-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.
Drug: PTX-200
During the Phase I study, increasing dose levels of PTX-200 will be administered as an intravenous infusion on Day 1 each cycle. Triciribine will be infused over 1 hour on Day 1 of each 21 day cycle. The initial dose level will be 25 mg/m2 and each dose level will be increased by 10 mg/m2 to a maximum dose of 55 mg/m2
Other Names:
  • Triciribine Phosphate Monohydrate
Drug: Cytarabine
Cytarabine will be given at a dose of 400 mg/m2 as a continuous IV infusion on days 3-7 of each cycle.
Other Names:
  • Ara-C

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phospho-Akt (pAkt) expression within CD34+ leukemic blasts
Time Frame: 12 months
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prescient Therapeutics, Ltd.

Investigators

  • Principal Investigator: Jeffrey Lancet, MD, Moffitt Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 9, 2016

Primary Completion (Actual)

October 31, 2023

Study Completion (Actual)

March 4, 2024

Study Registration Dates

First Submitted

September 13, 2016

First Submitted That Met QC Criteria

October 7, 2016

First Posted (Estimated)

October 12, 2016

Study Record Updates

Last Update Posted (Actual)

April 5, 2024

Last Update Submitted That Met QC Criteria

April 3, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTX-200-AML-015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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