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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02119676




Registration number
NCT02119676
Ethics application status
Date submitted
17/04/2014
Date registered
22/04/2014
Date last updated
13/02/2018

Titles & IDs
Public title
Study of Ruxolitinib in Colorectal Cancer Patients
Scientific title
A Randomized, Double-Blind Study of Ruxolitinib or Placebo in Combination With Regorafenib in Subjects With Relapsed or Refractory Metastatic Colorectal Cancer
Secondary ID [1] 0 0
INCB18424-267
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
CRC (Colorectal Cancer) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ruxolitinib
Treatment: Drugs - Regorafenib
Treatment: Drugs - Placebo

Experimental: Ruxolitinib plus regorafenib -

Active Comparator: Placebo plus regorafenib -


Treatment: Drugs: Ruxolitinib
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.)

Treatment: Drugs: Regorafenib
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.)

Treatment: Drugs: Placebo
5 mg matching placebo tablets to be administered by mouth

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS) - 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.
Timepoint [1] 0 0
Baseline until death due to any cause; up to 16 months or data cut-off 11 FEB 2016.
Secondary outcome [1] 0 0
Progression Free Survival (PFS) - 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.
Timepoint [1] 0 0
Baseline through disease progression, or death due to any cause if sooner; up to 16 months or data cut-off 11 FEB 2016.
Secondary outcome [2] 0 0
Overall Response Rate (ORR) - 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.
Timepoint [2] 0 0
Baseline through end of study; up to 16 months or data cut-off 11 FEB 2016.
Secondary outcome [3] 0 0
Duration of Response - 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.
Timepoint [3] 0 0
Baseline through end of study; up to 16 months or data cut-off 11 FEB 2016.
Secondary outcome [4] 0 0
Percentage of Participants Achieving Disease Control - 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.
Timepoint [4] 0 0
Baseline through end of study; up to 16 months or data cut-off 11 FEB 2016.
Secondary outcome [5] 0 0
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) - 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.
Timepoint [5] 0 0
Baseline through approximately 30 days post treatment discontinuation;up to 16 months or data cut-off 27JAN 2016 for Substudy 1 and up to the data cut-off of 11FEB2016 for Substudy 2.

Eligibility
Key inclusion criteria
- Histologically or cytologically confirmed adenocarcinoma of the colon or rectum that
is metastatic.

- Previous treatment with fluoropyrimidine-, oxaliplatin- and irinotecan- based
chemotherapy, an anti-VEGF therapy (if no contraindication) and if KRAS wild type and
no contraindication, an anti-EGFR therapy.

- Radiographically measurable or evaluable disease (per RECIST v1.1)

- Life expectancy of = 12 weeks.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

- Three or more weeks have elapsed from the completion of previous treatment regimen and
subjects must have recovered or be at a new stable baseline from any related
toxicities.

- Prior radiotherapy to disease sites is allowed with certain protocol-defined
restrictions.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Prior treatment with regorafenib.

- Presence of active gastrointestinal disease or other condition that will interfere
significantly with the absorption of drugs.

- Active peptic ulcer disease, inflammatory bowel disease (eg, ulcerative colitis,
Crohn's disease), diverticulitis, or other gastrointestinal conditions with increased
risk of perforation or gastrointestinal bleeding.

- Recent history (= 3 months) or ongoing partial or complete bowel obstruction unless
due to disease under study and corrected with surgery.

- Blood pressure = 140/90 mmHg.

- Active bleeding diathesis or history of any major bleeding (eg, requiring transfusion
of red blood cells (RBCs), central nervous system (CNS) bleeding, or significant
hemoptysis within 6 months of enrollment. Subjects with bleeding secondary to
underlying disease (including gastrointestinal (GI) perforation or fistula) that has
been corrected by surgery or alternative procedure may be included.

- Clinically significant cardiac disease including unstable angina, acute myocardial
infarction within 6 months from Day 1 of study drug administration, New York Heart
Association Class II, III, or IV congestive heart failure, and arrhythmia requiring
therapy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Bentleigh East
Recruitment hospital [2] 0 0
- Herston
Recruitment hospital [3] 0 0
- Kurralta Park
Recruitment hospital [4] 0 0
- New Lambton Heights
Recruitment hospital [5] 0 0
- Randwick
Recruitment postcode(s) [1] 0 0
- Bentleigh East
Recruitment postcode(s) [2] 0 0
- Herston
Recruitment postcode(s) [3] 0 0
- Kurralta Park
Recruitment postcode(s) [4] 0 0
- New Lambton Heights
Recruitment postcode(s) [5] 0 0
- Randwick
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
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United States of America
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Florida
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United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Iowa
Country [8] 0 0
United States of America
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Louisiana
Country [9] 0 0
United States of America
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Maryland
Country [10] 0 0
United States of America
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Missouri
Country [11] 0 0
United States of America
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Nebraska
Country [12] 0 0
United States of America
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Nevada
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United States of America
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New York
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United States of America
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Ohio
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United States of America
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Oregon
Country [16] 0 0
United States of America
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South Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
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Utah
Country [20] 0 0
United States of America
State/province [20] 0 0
Virginia
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United States of America
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Washington
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France
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Avignon Cedex 09
Country [23] 0 0
France
State/province [23] 0 0
Besançon
Country [24] 0 0
France
State/province [24] 0 0
Le Mans
Country [25] 0 0
France
State/province [25] 0 0
Lille
Country [26] 0 0
France
State/province [26] 0 0
Marseille Cedex 05
Country [27] 0 0
France
State/province [27] 0 0
Paris
Country [28] 0 0
Germany
State/province [28] 0 0
Augsburg
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Germany
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Halle
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Germany
State/province [30] 0 0
Hamburg
Country [31] 0 0
Israel
State/province [31] 0 0
Beer Sheva
Country [32] 0 0
Israel
State/province [32] 0 0
Haifa
Country [33] 0 0
Israel
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Petah Tikva
Country [34] 0 0
Israel
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Ramat Gan
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Israel
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Tel Aviv
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Korea, Democratic People's Republic of
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Soeul
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Spain
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Asturias
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Sevilla
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Spain
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Valencia
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United Kingdom
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Birmingham
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United Kingdom
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Bournemouth
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United Kingdom
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London
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United Kingdom
State/province [45] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Incyte Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02119676
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Albert Assad
Address 0 0
Incyte Corporation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02119676