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

NCT02930109 | Completed Phase 1

• 1 other identifier: PTX-200-AML-015
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Leukemia

Outcome Measures

Primary Outcomes (1)

• Treatment-related Adverse Events

  Number of participants with treatment-related Adverse Events as assessed by CTCAE v4.0 that result in dose-limitations (Phase I)

  12 months

Secondary Outcomes (1)

• Phospho-Akt (pAkt) expression within CD34+ leukemic blasts

  12 months

Study Arms (1)

PTX-200 and cytarabine

EXPERIMENTAL

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; Drug: Cytarabine

Interventions

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

Also known as: Triciribine Phosphate Monohydrate

PTX-200 and cytarabine

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.

Also known as: Ara-C

PTX-200 and cytarabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prescient Therapeutics, Ltd.: lead

Study Sites (2)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

University of Kansas Cancer Center

Fairway, Kansas, 60069, United States

Location

MeSH Terms

Interventions

Cytarabine

Intervention Hierarchy (Ancestors)

Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Jeffrey Lancet, MD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2016
• First Posted: October 12, 2016
• Study Start: December 9, 2016
• Primary Completion: October 31, 2023
• Study Completion: March 4, 2024
• Last Updated: April 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)