Safety of 24-Hour Infusion of ON 01910.Na in Patients With Advanced Cancer
|ClinicalTrials.gov Identifier: NCT01538563|
Recruitment Status : Completed
First Posted : February 24, 2012
Last Update Posted : June 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumors Advanced Cancer Cancer Neoplasms||Drug: rigosertib sodium||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Dose Escalation Study of ON 01910.Na by 24 Hour Continuous Infusion Per Week in Patients With Advanced Cancer|
|Study Start Date :||June 2006|
|Primary Completion Date :||July 2010|
|Study Completion Date :||November 2011|
Drug: rigosertib sodium
- ON 01910.Na Concentrate
- ON 01910.Na
- Number of dose limiting toxicities (DLTs) [ Time Frame: 21 days after first administration of ON 01910.Na ]
DLTs are defined as:
- Grade 3 non-hematological toxicity other than nausea, vomiting, diarrhea, fever, stomatitis, esophagitis/dysphagia.
- Recurrent grade 3 toxicity uncontrolled by optimal therapy or Grade 4 nausea, vomiting, diarrhea and fever.
- Grade 3 stomatitis and/or esophagitis/dysphagia for > 5 days.
- Grade 4 neutropenia or thrombocytopenia for > 5 days measured at least 2X 2-3 days apart.
- Neutropenic fever, as defined in Protocol.
- Failure to recover neutrophils (> 1,500 per microliter) or platelets (>75,000 per microliter) before the next weekly dose.
- Number of Adverse Events (AEs) [ Time Frame: 30 days after last infusion of study drug ]All AEs (except Grade 1 and 2 laboratories abnormalities that do not require an intervention) are recorded in Case Report Forms and source documentation.
- Severity of Adverse Events (AEs) [ Time Frame: 30 days after last infusion of study drug ]Severity of AEs are determined according to Common Terminology Criteria for Adverse Events (Version 3.0)
- Relationship of Adverse Events (AEs) to Study Treatment [ Time Frame: 30 days after last infusion of study drug ]Relationship assessed as Not related, Unlikely, Possibly, Probably, or, Definitely according to Guidance in Appendix II of Protocol.
- Concentration of ON 01910.Na in plasma versus time [ Time Frame: Up to 48 hours after infusion of study drug during Week 1 in Cycles 1 and 2 ]Blood samples will be collected at following time points: Pre-dose; 1 h after start of infusion; 3 h; 6 h; 12 h; 18 h; 24 h; 10 min after end of infusion; 20 min; 30 min; 1 h; 2 h; 4 h; 8 h; 24 h; and, 48 h. Plasma will be prepared from these samples. Concentration of ON 01910.Na will be determined by validated method.
- Change in size of target lesions recorded at baseline [ Time Frame: 30 days after last infusion of study drug ]The same method of assessment for each identified and recorded lesion will be used at baseline and each follow-up.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01538563
|United States, New York|
|Albert Einstein Cancer Center|
|The Bronx, New York, United States, 10461|
|Principal Investigator:||Sridhar Mani, MD||Albert Einstein College of Medicine, Inc.|