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

Phase 1

Completed

• Conditions: Acute Leukemia
• Interventions: Drug: PTX-200; Drug: Cytarabine

• Registration Number: NCT02930109
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2016-09-13
• Study First Submitted QC: 2016-10-07
• Study First Posted: 2016-10-12
• Study Start: 2016-12-09
• Primary Completion: 2023-10-31
• Status Verified: 2024-03
• Study Completion: 2024-03-04
• Last Update Submitted: 2024-04-03
• Last Update Posted: 2024-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PTX-200 and cytarabine	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.
PTX-200 and cytarabine	PTX-200	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.

Primary Outcome Measures

Name	Time	Method
Treatment-related Adverse Events	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

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

Trial Locations

Locations (2)

University of Kansas Cancer Center; 🇺🇸 Fairway, Kansas, United States

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States