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

Sponsor

Prescient Therapeutics, Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT02930109

Collaborator

(none)

Enrollment

Locations

Arm

Anticipated Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Leukemia	Drug: PTX-200 Drug: Cytarabine	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Masking Description:

Open Label

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PTX-200 and 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.	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 Other Names: Triciribine Phosphate Monohydrate Drug: Cytarabine Cytarabine will be given at a dose of 400 mg/m2 as a continuous IV infusion on days 3-7 of each cycle. Other Names: Ara-C

Arm

Intervention/Treatment

Experimental: PTX-200 and 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.

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

Other Names:

Triciribine Phosphate Monohydrate

Drug: Cytarabine

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

Other Names:

Ara-C

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Moffitt Cancer Center	Tampa	Florida	United States	33612
2	University of Kansas Cancer Center	Fairway	Kansas	United States	60069

Sponsors and Collaborators

Prescient Therapeutics, Ltd.

Investigators

Principal Investigator: Jeffrey Lancet, MD, Moffitt Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Prescient Therapeutics, Ltd.

ClinicalTrials.gov Identifier:

NCT02930109

Other Study ID Numbers:

PTX-200-AML-015

First Posted:

Oct 12, 2016

Last Update Posted:

Feb 9, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Leukemia

Acute Disease

Cytarabine

Study Results

No Results Posted as of Feb 9, 2021