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

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ClinicalTrials.gov Identifier: NCT02930109
Recruitment Status : Recruiting
First Posted : October 12, 2016
Last Update Posted : February 9, 2021
Sponsor:
Information provided by (Responsible Party):
Prescient Therapeutics, Ltd.

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.

Condition or disease Intervention/treatment Phase
Acute Leukemia Drug: PTX-200 Drug: Cytarabine Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Open Label
Primary Purpose: Treatment
Official Title: A Phase I-II Study of Triciribine Phosphate Monohydrate (PTX-200) Plus Cytarabine in Refractory or Relapsed Acute Leukemia
Actual Study Start Date : September 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia
Drug Information available for: Cytarabine

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 Name: 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 Name: Ara-C




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02930109


Contacts
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Contact: Claudia Gregorio-King claudia@ptxtherapeutics.com

Locations
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United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: William Cisceros    813-745-2071    William.CisnerosPrada@moffitt.org   
Principal Investigator: Jeffrey Lancet, MD         
United States, Kansas
University of Kansas Cancer Center Recruiting
Fairway, Kansas, United States, 60069
Contact: Emily Kelly    913-588-4714    ekelly4@kumc.edu   
Principal Investigator: Tara Lin, MD         
Sponsors and Collaborators
Prescient Therapeutics, Ltd.
Investigators
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Principal Investigator: Jeffrey Lancet, MD Moffitt Cancer Center
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Responsible Party: Prescient Therapeutics, Ltd.
ClinicalTrials.gov Identifier: NCT02930109    
Other Study ID Numbers: PTX-200-AML-015
First Posted: October 12, 2016    Key Record Dates
Last Update Posted: February 9, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Leukemia
Acute Disease
Neoplasms by Histologic Type
Neoplasms
Disease Attributes
Pathologic Processes
Cytarabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs