A Phase 1/2 interventional study of PTX-200 and Cytarabine in Acute Leukemia, sponsored by Prescient Therapeutics, Ltd.. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-05.
Sponsored by Prescient Therapeutics, Ltd. · Phase 1/2, Interventional, and Treatment
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.
Prescient Therapeutics, Ltd. is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
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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 · Drug: Cytarabine
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
Also known as: Triciribine Phosphate Monohydrate
Cytarabine will be given at a dose of 400 mg/m2 as a continuous IV infusion on days 3-7 of each cycle.
Also known as: Ara-C
Treatment-related Adverse Events
Number of participants with treatment-related Adverse Events as assessed by CTCAE v4.0 that result in dose-limitations (Phase I)
Time frame: 12 months
Phospho-Akt (pAkt) expression within CD34+ leukemic blasts
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
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Dec 2016 to primary completion in Oct 2023, 82 months.
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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cytarabine
Prescient Therapeutics, Ltd.