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



Status:Recruiting
Conditions:Other Indications, Blood Cancer
Therapuetic Areas:Oncology, Other
Healthy:No
Age Range:18 - Any
Updated:3/15/2019
Start Date:September 2016
End Date:December 2019
Contact:Claudia Gregorio-King
Email:claudia@ptxtherapeutics.com

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

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

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.

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
We found this trial at
2
sites
333 Cedar Street
New Haven, Connecticut 06520
(203) 785-4095
Principal Investigator: Thomas Prebet, MD
Phone: 475-434-7321
Yale Cancer Center Yale Cancer Center combines a tradition of innovative cancer treatment and quality...
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Tampa, Florida 33612
Principal Investigator: Jeffrey Lancet, MD
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Tampa, FL
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