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NCT Number: NCT02930109

A Study of PTX-200 (Triciribine) 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.

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Key information

Conditions

Acute Leukemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Moffitt Cancer Center, Tampa, Florida, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PTX-200

Drug

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

Cytarabine

Drug

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Prescient Therapeutics, Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2023
Study completion
2024
First posted
Oct 12, 2016
Registry last updated
Apr 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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