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

Acute Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02930109
• Other study ID #: PTX-200-AML-015
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: December 9, 2016
• Est. completion date: March 4, 2024

Study information

• Verified date: March 2024
• Source: Prescient Therapeutics, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A phase I-II open label study of PTX-200 in combination with cytarabine in the treatment of relapsed or refractory acute leukemia.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: March 4, 2024
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Disease
• Acute Leukemia
• Leukemia

Intervention

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

Locations

Country	Name	City	State
United States	University of Kansas Cancer Center	Fairway	Kansas
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Prescient Therapeutics, Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	12 months