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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00854945
Other study ID # Onconova 04-15
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received March 2, 2009
Last updated June 22, 2017
Start date January 2009
Est. completion date February 2014

Study information

Verified date June 2017
Source Onconova Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective of this study is to evaluate the efficacy and safety of ON 01910.Na Concentrate when it is administered as an intravenous continuous infusion (IVCI) over 72 hours once every 2 weeks in a broad population of MDS patients. Rationale for this study is based on the activity observed in another study with ON 01910.Na in patients with refractory anemia with excess blasts (RAEB) 1 and 2 MDS. This study will examine ON 01910.Na in a broader population of MDS and AML patients. This phase I/II study will establish the Maximum Tolerated Dose (MTD) starting with a dose of 800 mg/m2 per day administered over 24 hours for 2 consecutive days as a continuous intravenous infusion, once a week for 3 weeks of a 4-week cycle and examine the efficacy and safety profile at the MTD.


Description:

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Study Design


Intervention

Drug:
ON 01910.Na
1800 mg/day as a 24-hour continuous intravenous infusion administered three times a week every 2 weeks

Locations

Country Name City State
United States Columbia University Medical Center New York New York

Sponsors (1)

Lead Sponsor Collaborator
Onconova Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (4)

Garcia-Manero G, Fenaux P. Comprehensive Analysis of Safety: Rigosertib in 557 Patients with Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML). Blood Dec 2016, 128 (22) 2011; ASH 2016.

Jimeno A, Li J, Messersmith WA, Laheru D, Rudek MA, Maniar M, Hidalgo M, Baker SD, Donehower RC. Phase I study of ON 01910.Na, a novel modulator of the Polo-like kinase 1 pathway, in adult patients with solid tumors. J Clin Oncol. 2008 Dec 1;26(34):5504-10. doi: 10.1200/JCO.2008.17.9788. Epub 2008 Oct 27. — View Citation

Navada SC, Silverman LR. The safety and efficacy of rigosertib in the treatment of myelodysplastic syndromes. Expert Rev Anticancer Ther. 2016 Aug;16(8):805-10. doi: 10.1080/14737140.2016.1209413. Epub 2016 Jul 15. Review. — View Citation

Seetharam M, Fan AC, Tran M, Xu L, Renschler JP, Felsher DW, Sridhar K, Wilhelm F, Greenberg PL. Treatment of higher risk myelodysplastic syndrome patients unresponsive to hypomethylating agents with ON 01910.Na. Leuk Res. 2012 Jan;36(1):98-103. doi: 10.1016/j.leukres.2011.08.022. Epub 2011 Sep 14. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Response as defined per the 2000 International Working Group (IWG) Criteria in patients with MDS. 6 -12 months
Secondary Hematologic improvement. 6 - 12 months
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