Neoplasms

All Conditions

Digestive System Diseases

Adenocarcinoma

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Herbal and Botanical

All Drugs and Chemicals

Cola

5 mg tablets to be administered by mouth

Ruxolitinib 20 mg twice a day (BID) (Part 1) (NOTE: The starting dose for the randomized portion of study (Part 2) was 15 mg BID based on results from Part 1.)

Ruxolitinib

Regorafenib 160mg once daily for the first 21 days of each 28-day cycle. (NOTE: Dose interruptions and modifications for regorafenib are expected when toxicities occur in which dose interruptions or modifications are appropriate.)

Regorafenib

5 mg matching placebo tablets to be administered by mouth

Placebo

Albert Assad

The purpose of this study was to determine if ruxolitinib, in combination with regorafenib, is safe and effective in the treatment of metastatic colorectal cancer.

The study consisted of an open-label, Part 1 safety run-in (consisting of 1 to 3 cohorts of 9 subjects each), to confirm the safety of the regorafenib/ruxolitinib combination in subjects with relapsed or refractory metastatic colorectal cancer (CRC). If determined to be tolerable, Part 2 was to proceed as a randomized, double-blind study evaluating ruxolitinib or placebo in combination with regorafenib in subjects with relapsed or refractory metastatic CRC previously treated with fluoropyrimidine, oxaliplatin, and/or irinotecan based chemotherapy, an anti-vascular endothelial growth factor (VEGF) therapy and if Kirsten rat sarcoma (KRAS) wild type an anti-epidermal growth factor receptor (EGFR) therapy.

Subjects in the safety run-in received open-label ruxolitinib and regorafenib; for the randomized, double-blind portion of the study all subjects received regorafenib and either ruxolitinib or placebo in a 1:1 blinded manner. Treatment for all subjects consisted of repeating 28-day cycles. Regorafenib was self-administered for the first 21 days of each cycle, and ruxolitinib/placebo was self-administered during the entire 28-day cycle. Treatment cycles continued as long as the regimen is tolerated, and the subject does not meet the discontinuation criteria. When subjects discontinued regorafenib, ruxolitinib or placebo they remained in the study and were followed for subsequent treatment regimens which were initiated and survival.

Study of Ruxolitinib in Colorectal Cancer Patients

A Randomized, Double-Blind Study of Ruxolitinib or Placebo in Combination With Regorafenib in Subjects With Relapsed or Refractory Metastatic Colorectal Cancer

Overall survival is defined as the time from randomization to death due to any cause. Participants without death observed at the time of the analysis will be censored at last date known to be alive. The median overall survival time was estimated using the Kaplan-Meier method. Overall survival was compared between treatment groups using log-rank test.

Progressive Disease (PD) is defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at least a 20% increase in the sum of the Longest Diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, unequivocal progression of non-target lesions, or the appearance of new lesions.

Response defined per Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target and non-target lesions without new lesion; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions, non-target lesion not progressed, and no new lesion; Progressive Disease=20% increase in sum of longest diameter of target lesions, or non-target lesion progression, or identification of new lesion; Stable Disease=small changes that do not meet above criteria. ORR was defined as the proportion of participants who achieved a best response of either CR or PR. ORR=number of participants with CR or PR/number of participants randomized.

Duration of response is defined as the time from response (CR/PR) until the earliest date of disease progression determined by investigator assessment of objective radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause.

Disease control as measured by the percentage of participants whose best response was complete response (CR), partial response (PR), or stable disease (SD) per RECIST v.1.1.

TEAEs were defined as any adverse event (AE) during the study that began or worsened on or after the date of first dose of investigational product.

Incyte Corporation

The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.

Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.

Substudy 1: Ruxolitinib + Regorafenib

Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.

Substudy 1: Placebo + Regorafenib

Substudy 2: Ruxolitinib + Regorafenib

Substudy 2: Placebo + Regorafenib

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

The intent-to-treat (ITT) population consisted of participants that were randomized in the study.

Substudy 1 was terminated for futility at interim analysis and Substudy 2 was terminated per sponsor decision.

Study Director

Intent-to-treat (ITT) population included all subjects randomized in Substudy 1 and Substudy 2 of the study.

Overall Survival (OS)

Progression Free Survival (PFS)

Overall Response Rate (ORR)

No data displayed because outcome measure has not been analyzed. Duration of response analyses was not done since there were no responders in Substudy 1 and very few responders in Substudy 2 at data cutoff (27JAN2016 for Substudy 1 and 11Feb2016 for Substudy 2). Duration of response analysis was not done in both substudies.

Duration of Response

Percentage of Participants Achieving Disease Control

Participants with any TEAEs

Participants with Grade 3/4 TEAEs

Participants with any serious TEAE

Participants with a fatal TEAE

Participants who discontinued drug due to of TEAEs

Safety Population consists of all enrolled participants that received at least one dose of study drug.

Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)

Ruxolitinib 15 mg twice a day (BID) continuous with regorafenib 160 mg once daily (QD) for the first 21 days of each 28-day cycle.

Spots Global Cancer Trial Database for jakafi ®

Every month we try and update this database with for jakafi ® cancer trials from around the world to help patients and their families find trials that might be right for them.
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Spots Global Cancer Trial Database for jakafi ®

Every month we try and update this database with for jakafi ® cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for jakafi ® cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.