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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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)
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)
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)
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
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
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)
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
Sex
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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2016
Sample size
Target
Accrual to date
Final
396
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
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United States of America
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Arizona
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California
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Illinois
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Indiana
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Louisiana
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Maryland
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Missouri
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Nebraska
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Nevada
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New York
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Ohio
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Oregon
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South Carolina
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Tennessee
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Texas
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Utah
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Virginia
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Washington
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France
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Avignon Cedex 09
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France
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Besançon
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France
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Le Mans
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France
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Lille
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France
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Marseille Cedex 05
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France
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Paris
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Germany
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Augsburg
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Germany
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Halle
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Germany
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Hamburg
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Israel
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Beer Sheva
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Israel
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Haifa
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Israel
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Petah Tikva
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Korea, Republic of
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Soeul
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Asturias
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Spain
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Barcelona
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Madrid
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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
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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/study/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/study/NCT02119676