Colorectal CancerPhase 2NCT02277093
Pacritinib to Inhibit JAK/STAT Signaling in Refractory Colorectal Cancer
A Phase 2 study testing Pacritinib in people with Colorectal Cancer, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The investigators propose to assess the efficacy, progression-free survival, and adverse events of pacritinib in patients with refractory colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Pacritinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2015to 27 Oct 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed refractory colorectal cancer
- Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as >10 mm with CT scan, as >20 mm by chest x-ray, or >10 mm with calipers by clinical exam.
- Refractory to or intolerant of standard systemic therapy, including having received two or more standard available therapies known to prolong survival for which s/he was eligible, including FOLFOX or FOLFIRI with or without bevacizumab, aflibercept, cetuximab, or panitumumab
- At least 18 years of age.
- ECOG performance status < 2
- Life expectancy ≥ 12 weeks.
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- Normal bone marrow and organ function as defined below:
- Absolute neutrophil count ≥ 1,500/mcl
- Platelets ≥ 50,000/mcl
- Total bilirubin ≤ 2.0 x IULN
- AST (SGOT) / ALT (SGPT) ≤ 3.0 x IULN
- Serum creatinine ≤ 2.0 mg/dL OR creatinine clearance > 60 mL/min/1.73 m2 for patients with creatinine levels above 2.0 mg/dL
- Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
- Able to understand and willing to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Who cannot join
- Prior therapy with a JAK2 or FLT3 inhibitor.
- A history of other malignancy ≤ 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix.
- Received any chemotherapeutic or targeted agent for metastatic colorectal cancer within two weeks of initiation of study drug.
- Currently receiving any other investigational agents.
- Known brain metastases. Patients with known brain metastases must be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to pacritinib or other agents used in the study.
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- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant and/or breastfeeding. Patient must have a negative pregnancy test within 14 days of study entry.
- Known HIV-positivity on combination antiretroviral therapy because of the potential for pharmacokinetic interactions with pacritinib. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
- Use of potent cytochrome P450 3A4 (CYP3A4) inhibitor within one week of pacritinib initiation.
- Patients with CTCAE grade 2 cardiac arrhythmias may be considered for inclusion if the arrhythmias are stable, asymptomatic, and unlikely to affect patient safety. Patients will be excluded if they have ongoing cardiac dysrhythmias of CTCAE grade ≥ 3, corrected QT interval (QTc) prolongation >450ms, or other factors that increase the risk for QT interval prolongation (eg, heart failure, hypokalemia [defined as serum potassium <3.0mEq/L that is persistent and refractory to correction], or family history of long QT interval syndrome).
- Any gastrointestinal (GI) or metabolic condition that could interfere with absorption of oral medication such as ongoing grade 3 or higher diarrhea, constipation, nausea, or vomiting.
- Active viral hepatitis.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Phase II Study With Pacritinib to Inhibit JAK/STAT Signaling in Refractory Colorectal Cancer
The investigators propose to assess the efficacy, progression-free survival, and adverse events of pacritinib in patients with refractory colorectal cancer.
- Conditions
- Colorectal Cancer
- Being tested
- Pacritinib
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PacritinibDrug
Also called SB1518
| Study group | Role | What they receive |
|---|---|---|
| Pacritinib | Experimental | * 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 Receives: Drug: Pacritinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
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.
Measured: Through completion of follow-up (median follow-up was 6.61 months)
Secondary outcomes (4)
Toxicity Profile and Tolerability as Measured by Reportable Adverse Events
- 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.
Measured: Up to 28 days following last day of study treatment
Overall Response Rate (ORR)
- 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.
Measured: Through completion of follow-up (median follow-up was 6.61 months)
Time to Progression (TTP)
Measured: Through completion of follow-up (median follow-up was 6.61 months)
Overall Survival (OS)
-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.
Measured: Through completion of follow-up (median follow-up was 6.61 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2014 (estimated)
- Study start22 Sep 2015
- Primary completion31 Mar 2016
- Study completion27 Oct 2016
Why it stopped: FDA issued a clinical hold as pacritinib had increased side effects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- CTI BioPharma
- Responsible party
- Sponsor
- Investigators
- Benjamin R Tan, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02277093
- Sponsor's protocol ID
- 201412087
- Status last verified
- Apr 2017
- First submitted
- 24 Oct 2014
- Last updated
- 1 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study With Pacritinib to Inhibit JAK/STAT Signaling in Refractory Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02277093
- Acronym / sponsor ID
- 201412087
- Conditions
- Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: FDA issued a clinical hold as pacritinib had increased side effects
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- CTI BioPharma
- Study start
- 22 Sep 2015 (actual)
- Primary completion
- 31 Mar 2016 (actual)
- Study completion
- 27 Oct 2016 (actual)
- First posted
- 28 Oct 2014 (estimated)
- Results
- Posted 1 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators propose to assess the efficacy, progression-free survival, and adverse events of pacritinib in patients with refractory colorectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pacritinib | Experimental | Drug: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologically or cytologically confirmed refractory colorectal cancer
- Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as >10 mm with CT scan, as >20 mm by chest x-ray, or >10 mm with calipers by clinical exam.
- Refractory to or intolerant of standard systemic therapy, including having received two or more standard available therapies known to prolong survival for which s/he was eligible, including FOLFOX or FOLFIRI with or without bevacizumab, aflibercept, cetuximab, or panitumumab
- At least 18 years of age.
- ECOG performance status < 2
Key exclusion criteria (13 listed)
- Prior therapy with a JAK2 or FLT3 inhibitor.
- A history of other malignancy ≤ 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix.
- Received any chemotherapeutic or targeted agent for metastatic colorectal cancer within two weeks of initiation of study drug.
- Currently receiving any other investigational agents.
- Known brain metastases. Patients with known brain metastases must be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PacritinibAlso: SB1518 | Drug | Pacritinib |
Primary outcome
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.
4 secondary outcomes
Toxicity Profile and Tolerability as Measured by Reportable Adverse Events
Time frame: Up to 28 days following last day of study treatment
Overall Response Rate (ORR)
Time frame: Through completion of follow-up (median follow-up was 6.61 months)
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin R Tan, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pacritinib in people with Colorectal Cancer, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (PFS) (time frame: Through completion of follow-up (median follow-up was 6.61 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2017.