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Pacritinib to Inhibit JAK/STAT Signaling in Refractory Colorectal Cancer

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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
Sponsor:
Collaborator:
CTI BioPharma
Information provided by (Responsible Party):
Washington University School of Medicine

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Colorectal Cancer
Intervention Drug: Pacritinib
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pacritinib
Hide Arm/Group Description
  • Pacritinib is an oral drug which will be taken on an outpatient basis daily on a 28-day cycle at a dose of 200 mg twice a day (BID)
  • Pacritinib should be take at approximately the same times every day with a glass of water, with or without food
Period Title: Overall Study
Started 11
Completed 11
Not Completed 0
Arm/Group Title Pacritinib
Hide Arm/Group Description
  • Pacritinib is an oral drug which will be taken on an outpatient basis daily on a 28-day cycle at a dose of 200 mg twice a day (BID)
  • Pacritinib should be take at approximately the same times every day with a glass of water, with or without food
Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 11 participants
63
(43 to 80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
7
  63.6%
Male
4
  36.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants
11
Primary Site of Cancer  
Measure Type: Count of Participants
Unit of measure:  Participants
Right colon Number Analyzed 11 participants
7
  63.6%
Left colon Number Analyzed 11 participants
2
  18.2%
Rectal Number Analyzed 11 participants
2
  18.2%
Baseline c-reactive protein (CRP)   [1] 
Median (Full Range)
Unit of measure:  mg/L
Number Analyzed 9 participants
12.1
(2.1 to 147)
[1]
Measure Analysis Population Description: 2 out of the 11 patients did not have a baseline c-reactive protein.
Prior lines of therapy for metastatic disease  
Median (Full Range)
Unit of measure:  Prior lines of therapy
Number Analyzed 11 participants
4
(2 to 6)
1.Primary Outcome
Title Progression-free Survival (PFS)
Hide Description

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.

Time Frame Through completion of follow-up (median follow-up was 6.61 months)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pacritinib
Hide Arm/Group Description:
  • Pacritinib is an oral drug which will be taken on an outpatient basis daily on a 28-day cycle at a dose of 200 mg twice a day (BID)
  • Pacritinib should be take at approximately the same times every day with a glass of water, with or without food
Overall Number of Participants Analyzed 11
Median (Inter-Quartile Range)
Unit of Measure: months
1.91
(1.81 to 8.75)
2.Secondary Outcome
Title Toxicity Profile and Tolerability as Measured by Reportable Adverse Events
Hide Description
  • 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.
Time Frame Up to 28 days following last day of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pacritinib
Hide Arm/Group Description:
  • Pacritinib is an oral drug which will be taken on an outpatient basis daily on a 28-day cycle at a dose of 200 mg twice a day (BID)
  • Pacritinib should be take at approximately the same times every day with a glass of water, with or without food
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: adverse event
Diarrhea 1
Edema limbs 1
Edema face 1
Fatigue 1
Localized edema 1
Blood bilirubin increased 1
Dyspnea 1
Rash maculopapular 1
3.Secondary Outcome
Title Overall Response Rate (ORR)
Hide Description
  • 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 Frame Through completion of follow-up (median follow-up was 6.61 months)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pacritinib
Hide Arm/Group Description:
  • Pacritinib is an oral drug which will be taken on an outpatient basis daily on a 28-day cycle at a dose of 200 mg twice a day (BID)
  • Pacritinib should be take at approximately the same times every day with a glass of water, with or without food
Overall Number of Participants Analyzed 11
Measure Type: Count of Participants
Unit of Measure: Participants
Complete response
0
   0.0%
Partial response
0
   0.0%
Stable disease
1
   9.1%
Progressive disease
6
  54.5%
Not evaluable
4
  36.4%
4.Secondary Outcome
Title Time to Progression (TTP)
Hide Description [Not Specified]
Time Frame Through completion of follow-up (median follow-up was 6.61 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients who had their first measurement scans were evaluable for this outcome measure.
Arm/Group Title Pacritinib
Hide Arm/Group Description:
  • Pacritinib is an oral drug which will be taken on an outpatient basis daily on a 28-day cycle at a dose of 200 mg twice a day (BID)
  • Pacritinib should be take at approximately the same times every day with a glass of water, with or without food
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: months
1.73  (0.26)
5.Secondary Outcome
Title Overall Survival (OS)
Hide Description -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.
Time Frame Through completion of follow-up (median follow-up was 6.61 months)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pacritinib
Hide Arm/Group Description:
  • Pacritinib is an oral drug which will be taken on an outpatient basis daily on a 28-day cycle at a dose of 200 mg twice a day (BID)
  • Pacritinib should be take at approximately the same times every day with a glass of water, with or without food
Overall Number of Participants Analyzed 11
Median (95% Confidence Interval)
Unit of Measure: months
6.61
(2.79 to 9.34)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pacritinib
Hide Arm/Group Description
  • Pacritinib is an oral drug which will be taken on an outpatient basis daily on a 28-day cycle at a dose of 200 mg twice a day (BID)
  • Pacritinib should be take at approximately the same times every day with a glass of water, with or without food
All-Cause Mortality
Pacritinib
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Pacritinib
Affected / at Risk (%)
Total   4/11 (36.36%) 
Blood and lymphatic system disorders   
Anemia  1  1/11 (9.09%) 
Gastrointestinal disorders   
Nausea  1  1/11 (9.09%) 
Investigations   
Alkaline phosphatase increased  1  1/11 (9.09%) 
Platelet count decreased  1  1/11 (9.09%) 
Respiratory, thoracic and mediastinal disorders   
Pleural effusion  1  1/11 (9.09%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pacritinib
Affected / at Risk (%)
Total   10/11 (90.91%) 
Gastrointestinal disorders   
Abdominal pain  1  2/11 (18.18%) 
Abdominal distension  1  1/11 (9.09%) 
Constipation  1  3/11 (27.27%) 
Diarrhea  1  1/11 (9.09%) 
Dyspepsia  1  1/11 (9.09%) 
Flatulence  1  1/11 (9.09%) 
Mucositis oral  1  2/11 (18.18%) 
Nausea  1  5/11 (45.45%) 
Rectal pain  1  1/11 (9.09%) 
Stomach pain  1  1/11 (9.09%) 
Vomiting  1  1/11 (9.09%) 
Abdominal cramps  1  2/11 (18.18%) 
General disorders   
Chills  1  1/11 (9.09%) 
Edema limbs  1  2/11 (18.18%) 
Edema face  1  1/11 (9.09%) 
Fatigue  1  3/11 (27.27%) 
Localized edema  1  1/11 (9.09%) 
Infections and infestations   
Anorectal infection  1  1/11 (9.09%) 
Investigations   
Blood bilirubin increased  1  1/11 (9.09%) 
Metabolism and nutrition disorders   
Anorexia  1  3/11 (27.27%) 
Hyperglycemia  1  1/11 (9.09%) 
Musculoskeletal and connective tissue disorders   
Flank pain  1  1/11 (9.09%) 
Pain in extremity  1  1/11 (9.09%) 
Nervous system disorders   
Dizziness  1  1/11 (9.09%) 
Dysgeusia  1  1/11 (9.09%) 
Headache  1  1/11 (9.09%) 
Peripheral motor neuropathy  1  1/11 (9.09%) 
Psychiatric disorders   
Insomnia  1  3/11 (27.27%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  2/11 (18.18%) 
Dyspnea  1  2/11 (18.18%) 
Hiccups  1  1/11 (9.09%) 
Hoarseness  1  1/11 (9.09%) 
Hypoxia  1  1/11 (9.09%) 
Nasal congestion  1  1/11 (9.09%) 
Skin and subcutaneous tissue disorders   
Rash maculopapular  1  1/11 (9.09%) 
Sweating  1  1/11 (9.09%) 
Vascular disorders   
Hypertension  1  2/11 (18.18%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Please note that the study ended early due to the FDA issuing a clinical hold as pacritinib had increased side effects.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Benjamin R. Tan
Organization: Washington University School of Medicine
Phone: 314-362-9915
EMail: btan@wustl.edu
Layout table for additonal information
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02277093    
Other Study ID Numbers: 201412087
First Submitted: October 24, 2014
First Posted: October 28, 2014
Results First Submitted: March 16, 2017
Results First Posted: May 1, 2017
Last Update Posted: May 1, 2017