Pacritinib to Inhibit JAK/STAT Signaling in Refractory Colorectal Cancer
|ClinicalTrials.gov Identifier: NCT02277093|
Recruitment Status : Terminated (FDA issued a clinical hold as pacritinib had increased side effects)
First Posted : October 28, 2014
Results First Posted : May 1, 2017
Last Update Posted : May 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: Pacritinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study With Pacritinib to Inhibit JAK/STAT Signaling in Refractory Colorectal Cancer|
|Actual Study Start Date :||September 22, 2015|
|Actual Primary Completion Date :||March 31, 2016|
|Actual Study Completion Date :||October 27, 2016|
Other Name: SB1518
- Progression-free Survival (PFS) [ Time Frame: Through completion of follow-up (median follow-up was 6.61 months) ]
PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
Progression - at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.
- Toxicity Profile and Tolerability as Measured by Reportable Adverse Events [ Time Frame: Up to 28 days following last day of study treatment ]
- The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.
- Reportable adverse events will be tracked for 28 days following the last day of study treatment. For the purposes of this protocol, reportable adverse events are events that are greater than or equal to grade 2 and are considered possibly, probably, or definitely related to study treatment.
- Overall Response Rate (ORR) [ Time Frame: Through completion of follow-up (median follow-up was 6.61 months) ]
- The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria.
- Using RECIST 1.1
- The follow-up time was calculated from the start of treatment until death or on the final collection date of data on 10/27/2016.
- Time to Progression (TTP) [ Time Frame: Through completion of follow-up (median follow-up was 6.61 months) ]
- Overall Survival (OS) [ Time Frame: Through completion of follow-up (median follow-up was 6.61 months) ]-The follow-up time for OS was calculated from the start of treatment until death or on the final collection date of data on 10/27/2016.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02277093
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Benjamin R Tan, M.D.||Washington University School of Medicine|