NCT01009931|TerminatedPhase 2Results
Study Stopped
Study was terminated early due to lack of experimental medication (supply issues)
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Study was terminated early due to lack of experimental medication (supply issues)
A Phase II Study of 12-O-tetradecanoylphorbol-13-acetate (TPA) Plus Dexamethasone & Choline Magnesium Trisalicylate in the Treatment of Patients With Relapsed/Refractory Acute Myelogenous Leukemia
Sponsor study identifier
Secondary identifiers
NIH
OTHER · IRB #
NIH
OTHER · CTRP (Clinical Trails Reporting Program)
interventional
1
1 country
1
Study Start
March 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2011
Actual (reported)Study Completion
September 2014
Actual (reported)This phase II trial is studying the side effects and how well giving tetradecanoylphorbol acetate together with dexamethasone and choline magnesium trisalicylate works in treating patients with relapsed or refractory acute myeloid leukemia.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 6, 2009
Actual (reported)November 9, 2009
Actual (reported)March 2011
Date type not reportedThis date has not been verified as actual or estimated.
October 2011
Actual (reported)September 2014
Actual (reported)June 22, 2015
Actual (reported)Response Rate > 20% for 12-O-tetradecanoylphorbol-13- Acetate (TPA)+ Dexamethasone + Choline Magnesium Trisalicylate(Trilisate)
42 months
Grade 3 and 4 Non-hematologic Treatment-related Toxicity Rates < 25%
43 months
Effects of Treatment on Immunophenotype, Signaling Profile, and Nuclear NF-kB Expression
48 months
12-O-tetradecanoylphorbol-13-acetate (TPA) plus Dexamethasone \& Choline magnesium trisalicylate (Trilisate)
The initial dose of TPA will be 1 mg/week x 3 weeks (Day 1, 8, 15). Up to 6 cycles.
Dexamethasone 10 mg PO qid will start 24h prior to TPA and continue for 24h after TPA x 3 weeks. Up to 6 cycles.
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
Roger Strair, MD, PhD
Rutgers Cancer Institute of New Jersey
1 participants (actual enrollment reported by the registry).
First Submitted
November 6, 2009
First Posted
November 9, 2009
Study Start
March 2011
Date type not reportedThis date has not been verified as actual or estimated.
Choline magnesium trisalicylate 1500 mg PO TID will begin 24h prior to TPA and continue for 24h post TPA x 3 weeks. Up to 6 cycles.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
October 2011
Actual (reported)Study Completion
September 2014
Actual (reported)Last Updated
November 4, 2015
Results First Posted
June 22, 2015
Record last verified: 2015-11
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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