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

NCT02930109 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2024-04-05

No results posted yet for this study

Summary

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

Conditions

Interventions

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

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.

Sponsors & Collaborators

  • Prescient Therapeutics, Ltd.

    lead INDUSTRY

Principal Investigators

  • Jeffrey Lancet, MD · Moffitt Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-09
Primary Completion
2023-10-31
Completion
2024-03-04

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02930109 on ClinicalTrials.gov