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

Prescient Therapeutics

Status and phase: Completed; Phase 2; Phase 1

Conditions: Acute Leukemia

Treatments: Drug: Cytarabine; Drug: PTX-200

Study type: Interventional

Funder types: Industry

Identifiers

NCT02930109

PTX-200-AML-015

Details and patient eligibility

About

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

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

PTX-200 and cytarabine

Experimental group

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.

Treatment:

Drug: PTX-200

Drug: Cytarabine