Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

* 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

Pacritinib

Benjamin R Tan, M.D.

The investigators propose to assess the efficacy, progression-free survival, and adverse events of pacritinib in patients with refractory colorectal cancer.

Pacritinib to Inhibit JAK/STAT Signaling in Refractory Colorectal Cancer

Phase II Study With Pacritinib to Inhibit JAK/STAT Signaling in Refractory Colorectal Cancer

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.

* 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.

* 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.

-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.

CTI BioPharma

Washington University School of Medicine

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Right colon

Left colon

Rectal

Primary Site of Cancer

2 out of the 11 patients did not have a baseline c-reactive protein.

Baseline c-reactive protein (CRP)

Prior lines of therapy for metastatic disease

Please note that the study ended early due to the FDA issuing a clinical hold as pacritinib had increased side effects.

Benjamin R. Tan

Progression-free Survival (PFS)

Diarrhea

Edema limbs

Edema face

Fatigue

Localized edema

Blood bilirubin increased

Dyspnea

Rash maculopapular

Toxicity Profile and Tolerability as Measured by Reportable Adverse Events

Overall Response Rate (ORR)

Only patients who had their first measurement scans were evaluable for this outcome measure.

Time to Progression (TTP)

Overall Survival (OS)

Overall Study

Spots Global Cancer Trial Database for Pacritinib to Inhibit JAK/STAT Signaling in Refractory Colorectal Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial