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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02930109

Enrollment

Registered

2016-10-12

Start date

2016-12-09

Completion date

2024-03-04

Last updated

2024-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Leukemia

Brief summary

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.

Interventions

DRUGPTX-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

DRUGCytarabine

Cytarabine will be given at a dose of 400 mg/m2 as a continuous IV infusion on days 3-7 of each cycle.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Masking description

Open Label

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Phospho-Akt (pAkt) expression within CD34+ leukemic blasts	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026