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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01538537
Other study ID # Onconova 04-02
Secondary ID
Status Completed
Phase Phase 1
First received February 20, 2012
Last updated June 22, 2017
Start date August 2006
Est. completion date January 2012

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 determine the largest dose of ON 01910.Na (rigosertib sodium) that can be given safely as a 3-day continuous infusion once every 2 weeks (2-week cycle) in patients with advanced cancer.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
rigosertib sodium
ON 01910.Na will be supplied as a sterile, concentrated solution (75 mg/ml) in labeled, sealed glass vials. ON 01910.Na concentrated solution (75 mg/ml) must be diluted before intravenous administration. The starting dose will be 50 mg/m2 over 24 hour infusion daily for 3 days. A fresh infusion must be prepared for each day of the 3-day continuous infusion. This 3-day continuous treatment followed by 11 days without administration of study drug will constitute 1 Cycle. Cycles can be repeated every 2 weeks. The dosing of ON 01910.Na will be based on body surface area (BSA). In the absence of toxicity that would cause accelerated dose escalation to cease, drug doses are planned to escalate every 3 weeks.

Locations

Country Name City State
United States Mount Sinai School of Medicine New York New York

Sponsors (1)

Lead Sponsor Collaborator
Onconova Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

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.

Ohnuma T, Lehrer D, Ren C, Cho SY, Maniar M, Silverman L, Sung M, Gretz HF 3rd, Benisovich V, Navada S, Akahoho E, Wilck E, Taft DR, Roboz J, Wilhelm F, Holland JF. Phase 1 study of intravenous rigosertib (ON 01910.Na), a novel benzyl styryl sulfone struc — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of dose limiting toxicities (DLTs) DLTs are defined as:
Grade 3 non-hematological toxicity other than nausea, vomiting, diarrhea, fever, stomatitis, esophagitis/dysphagia.
Grade 3 nausea and vomiting uncontrolled by antiemetics; Grade 3 diarrhea uncontrolled by antidiarrheal agents; Grade 3 drug-induced fever uncontrolled by antipyretics.
Grade 3 stomatitis and/or esophagitis/dysphagia lasting >3 days.
Grade 4 neutropenia or thrombocytopenia lasting >5 days.
Episode of neutropenic fever, as defined in Protocol.
Failure to recover neutrophils (>1,500 per microliter) or platelets (>75,000 per microliter) by day 28.
28 days after start of first administration of ON 01910.Na
Secondary Number of Adverse Events (AEs) All adverse events (except grade 1 and 2 laboratory abnormalities that do not require an intervention), regardless of causal relationship, are recorded in the case report form and source documentation. 30 days after last infusion of study drug
Secondary Severity of Adverse Events Severity of AEs are determined according to the NCI Common Terminology Criteria for Adverse Events, Version 3.0. 30 days after last infusion of study drug
Secondary Relationship of Adverse Events (AEs) to Study Treatment Relationship assessed as Not related, Unlikely, Possibly, Probably, or, Definitely according to Guidance in Appendix II of Protocol. 30 days after last infusion of study drug
Secondary Concentration of ON 01910.Na in plasma versus time Blood samples for subsequent preparation of plasma and determination of concentration of ON 01910.Na will be collected at pre-dose at 1 hr, 3 hr, 6 hr, 24 hr, 48 hr and 72 hr (10 min, prior to completion of infusion). After the completion of the infusion, samples will be collected at 10 min, 20 min, 30 min, 1 hr, 2 hr, 4 hr, 8 hr, 24 hr, 48 hr, and 72 hr. Up to 72 hours after end of infusion of study drug in Cycles 1 and 4
Secondary Change in size of target lesions recorded at baseline The same method of assessment for each identified and recorded lesion will be used at baseline and each follow-up. 30 days after last infusion of study drug
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