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

Primary Purpose

Acute Leukemia

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PTX-200
Cytarabine
Sponsored by
Prescient Therapeutics, Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Moffitt Cancer CenterRecruiting
  • University of Kansas Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PTX-200 and cytarabine

Arm Description

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
September 13, 2016
Last Updated
February 8, 2021
Sponsor
Prescient Therapeutics, Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02930109
Brief Title
A Study of PTX-200 (Triciribine) Plus Cytarabine in Refractory or Relapsed Acute Leukemia
Official Title
A Phase I-II Study of Triciribine Phosphate Monohydrate (PTX-200) Plus Cytarabine in Refractory or Relapsed Acute Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Prescient Therapeutics, Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Open Label
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PTX-200 and cytarabine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
PTX-200
Other Intervention Name(s)
Triciribine Phosphate Monohydrate
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Cytarabine
Other Intervention Name(s)
Ara-C
Intervention Description
Cytarabine will be given at a dose of 400 mg/m2 as a continuous IV infusion on days 3-7 of each cycle.
Primary Outcome Measure Information:
Title
Treatment-related Adverse Events
Description
Number of participants with treatment-related Adverse Events as assessed by CTCAE v4.0 that result in dose-limitations (Phase I)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Phospho-Akt (pAkt) expression within CD34+ leukemic blasts
Description
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
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claudia Gregorio-King
Email
claudia@ptxtherapeutics.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Lancet, MD
Organizational Affiliation
Moffitt Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Cisceros
Phone
813-745-2071
Email
William.CisnerosPrada@moffitt.org
First Name & Middle Initial & Last Name & Degree
Jeffrey Lancet, MD
Facility Name
University of Kansas Cancer Center
City
Fairway
State/Province
Kansas
ZIP/Postal Code
60069
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Kelly
Phone
913-588-4714
Email
ekelly4@kumc.edu
First Name & Middle Initial & Last Name & Degree
Tara Lin, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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