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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Prescient Therapeutics, Ltd.

Current Primary Outcome: Treatment-related Adverse Events [ Time Frame: 12 months ]

Number of participants with treatment-related Adverse Events as assessed by CTCAE v4.0 that result in dose-limitations (Phase I)


Original Primary Outcome: Same as current

Current Secondary Outcome: Phospho-Akt (pAkt) expression within CD34+ leukemic blasts [ Time Frame: 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


Original Secondary Outcome: Same as current

Information By: Prescient Therapeutics, Ltd.

Dates:
Date Received: September 13, 2016
Date Started: September 2016
Date Completion: September 2018
Last Updated: May 17, 2017
Last Verified: May 2017