MedTrace Logo

Safety and Pharmacokinetic Study of Oral ON 01910.Na in Patients With Myelodysplastic Syndrome

NCT01048619 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2017-06-23

No results posted yet for this study

Summary

In other clinical studies, ON 01910.Na has been safely given intravenously to Patients with advanced cancers. However, to treat some Patients, it may be better if ON 01910.Na could be given by mouth. This study will determine if it is safe to give ON 01910.Na by mouth, what is the highest dose can be safely given by mouth, and how much of the drug gets from the stomach into the blood stream when it is given by mouth.

Conditions

Interventions

DRUG

ON 01910.Na

In Part I, the bioavailability and tolerability of ON 01910.Na as single, oral, escalating doses in a fasting state (defined as no less than 30 min before next meal) is studied. Three patients get 70mg dose the 1st week. In the absence of drug-related grade 2 toxicity or higher, doses will escalate in each patient weekly (wk) to 140mg (wk 2), 280mg (wk 3), 560mg (wk 4) and 700mg (wk 5). At end of Part I all patients will be eligible for Part II. Part II proceeds if drug is measured in plasma and DLT not observed at 70mg dose in Part I. The maximum tolerated dose of oral ON 01910.Na administered in a fasting state (defined as no less than 30 min before next meal) twice a day for 14 days will be determined following an adaptive design at doses between 70 and 700mg.

Sponsors & Collaborators

  • Traws Pharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Rami Komrokji, MD · H. Lee Moffitt Cancer Center and Research Institute

  • Azra Raza, MD · Columbia University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2014-11-30
Completion
2015-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT01048619 on ClinicalTrials.gov