Trial Outcomes & Findings for Pacritinib to Inhibit JAK/STAT Signaling in Refractory Colorectal Cancer (NCT NCT02277093)
NCT ID: NCT02277093
Last Updated: 2017-05-01
Results Overview
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.
TERMINATED
PHASE2
11 participants
Through completion of follow-up (median follow-up was 6.61 months)
2017-05-01
Participant Flow
Participant milestones
| Measure |
Pacritinib
* 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 Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
2 out of the 11 patients did not have a baseline c-reactive protein.
Baseline characteristics by cohort
| Measure |
Pacritinib
n=11 Participants
* 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
|
|---|---|
|
Age, Continuous
|
63 years
n=11 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=11 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=11 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=11 Participants
|
|
Primary Site of Cancer
Right colon
|
7 Participants
n=11 Participants
|
|
Primary Site of Cancer
Left colon
|
2 Participants
n=11 Participants
|
|
Primary Site of Cancer
Rectal
|
2 Participants
n=11 Participants
|
|
Baseline c-reactive protein (CRP)
|
12.1 mg/L
n=9 Participants • 2 out of the 11 patients did not have a baseline c-reactive protein.
|
|
Prior lines of therapy for metastatic disease
|
4 prior lines of therapy
n=11 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Pacritinib
n=11 Participants
* 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
|
|---|---|
|
Progression-free Survival (PFS)
|
1.91 months
Interval 1.81 to 8.75
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Pacritinib
n=11 Participants
* 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
|
|---|---|
|
Toxicity Profile and Tolerability as Measured by Reportable Adverse Events
Diarrhea
|
1 adverse event
|
|
Toxicity Profile and Tolerability as Measured by Reportable Adverse Events
Edema limbs
|
1 adverse event
|
|
Toxicity Profile and Tolerability as Measured by Reportable Adverse Events
Edema face
|
1 adverse event
|
|
Toxicity Profile and Tolerability as Measured by Reportable Adverse Events
Fatigue
|
1 adverse event
|
|
Toxicity Profile and Tolerability as Measured by Reportable Adverse Events
Localized edema
|
1 adverse event
|
|
Toxicity Profile and Tolerability as Measured by Reportable Adverse Events
Blood bilirubin increased
|
1 adverse event
|
|
Toxicity Profile and Tolerability as Measured by Reportable Adverse Events
Dyspnea
|
1 adverse event
|
|
Toxicity Profile and Tolerability as Measured by Reportable Adverse Events
Rash maculopapular
|
1 adverse event
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Pacritinib
n=11 Participants
* 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 Response Rate (ORR)
Complete response
|
0 Participants
|
|
Overall Response Rate (ORR)
Partial response
|
0 Participants
|
|
Overall Response Rate (ORR)
Stable disease
|
1 Participants
|
|
Overall Response Rate (ORR)
Progressive disease
|
6 Participants
|
|
Overall Response Rate (ORR)
Not evaluable
|
4 Participants
|
SECONDARY outcome
Timeframe: Through completion of follow-up (median follow-up was 6.61 months)Population: Only patients who had their first measurement scans were evaluable for this outcome measure.
Outcome measures
| Measure |
Pacritinib
n=7 Participants
* 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
|
|---|---|
|
Time to Progression (TTP)
|
1.73 months
Standard Deviation 0.26
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Pacritinib
n=11 Participants
* 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 Survival (OS)
|
6.61 months
Interval 2.79 to 9.34
|
Adverse Events
Pacritinib
Serious adverse events
| Measure |
Pacritinib
n=11 participants at risk
* 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
|
|---|---|
|
Investigations
Alkaline phosphatase increased
|
9.1%
1/11
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
9.1%
1/11
|
|
Blood and lymphatic system disorders
Anemia
|
9.1%
1/11
|
|
Investigations
Platelet count decreased
|
9.1%
1/11
|
|
Gastrointestinal disorders
Nausea
|
9.1%
1/11
|
Other adverse events
| Measure |
Pacritinib
n=11 participants at risk
* 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
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
18.2%
2/11
|
|
Gastrointestinal disorders
Abdominal distension
|
9.1%
1/11
|
|
Gastrointestinal disorders
Constipation
|
27.3%
3/11
|
|
Gastrointestinal disorders
Diarrhea
|
9.1%
1/11
|
|
Gastrointestinal disorders
Dyspepsia
|
9.1%
1/11
|
|
Gastrointestinal disorders
Flatulence
|
9.1%
1/11
|
|
Gastrointestinal disorders
Mucositis oral
|
18.2%
2/11
|
|
Gastrointestinal disorders
Nausea
|
45.5%
5/11
|
|
Gastrointestinal disorders
Rectal pain
|
9.1%
1/11
|
|
Gastrointestinal disorders
Stomach pain
|
9.1%
1/11
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
1/11
|
|
Gastrointestinal disorders
Abdominal cramps
|
18.2%
2/11
|
|
General disorders
Chills
|
9.1%
1/11
|
|
General disorders
Edema limbs
|
18.2%
2/11
|
|
General disorders
Edema face
|
9.1%
1/11
|
|
General disorders
Fatigue
|
27.3%
3/11
|
|
General disorders
Localized edema
|
9.1%
1/11
|
|
Infections and infestations
Anorectal infection
|
9.1%
1/11
|
|
Investigations
Blood bilirubin increased
|
9.1%
1/11
|
|
Metabolism and nutrition disorders
Anorexia
|
27.3%
3/11
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
9.1%
1/11
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
9.1%
1/11
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.1%
1/11
|
|
Nervous system disorders
Dizziness
|
9.1%
1/11
|
|
Nervous system disorders
Dysgeusia
|
9.1%
1/11
|
|
Nervous system disorders
Headache
|
9.1%
1/11
|
|
Nervous system disorders
Peripheral motor neuropathy
|
9.1%
1/11
|
|
Psychiatric disorders
Insomnia
|
27.3%
3/11
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.2%
2/11
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
18.2%
2/11
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
9.1%
1/11
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
9.1%
1/11
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
9.1%
1/11
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
9.1%
1/11
|
|
Skin and subcutaneous tissue disorders
Rash maculopapular
|
9.1%
1/11
|
|
Skin and subcutaneous tissue disorders
Sweating
|
9.1%
1/11
|
|
Vascular disorders
Hypertension
|
18.2%
2/11
|
Additional Information
Benjamin R. Tan
Washington University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place