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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02930109
Other study ID # PTX-200-AML-015
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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