Trial record 8 of 76 for:    INCB018424

Study of Ruxolitinib in Colorectal Cancer Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Incyte Corporation
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT02119676
First received: April 17, 2014
Last updated: June 2, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention Phase
Metastatic Colorectal Cancer
Drug: Ruxolitinib
Drug: Regorafenib
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind Study of Ruxolitinib or Placebo in Combination With Regorafenib in Subjects With Relapsed or Refractory Metastatic Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Incyte Corporation:

Primary Outcome Measures:
  • Part 1: Determination of the dose of ruxolitinib that is safe and tolerable in combination with regorafenib as measured by the number of dose-limiting toxicities (DLTs) observed in the evaluation cohort [ Time Frame: Baseline through Day 28 ] [ Designated as safety issue: Yes ]
  • Part 2: Overall Survival (OS) [ Time Frame: Randomization until death due to any cause. Approximately 28 months.] ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: Randomization through disease progression, or death due to any cause if sooner. Approximately 28 months. ] [ Designated as safety issue: No ]
    PFS is defined as the time from randomization 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, if sooner

  • Objective Response Rate [ Time Frame: Baseline through end of study. Approximately 28 months. ] [ Designated as safety issue: No ]
    Objective response rate determined by radiographic disease assessments per RECIST v1.1, by investigator assessment

  • Duration of Response [ Time Frame: Baseline through end of study. 28 months. ] [ Designated as safety issue: No ]
    Duration of response determined by radiographic disease assessment per RECIST v1.1, by investigator assessment

  • Safety and tolerability of the treatment regimens assessed by a summary of adverse events and clinical laboratory assessments. [ Time Frame: Baseline through approximately 30 days post treatment discontinuation. Approximately 28 months. ] [ Designated as safety issue: Yes ]
  • Disease Control [ Time Frame: Baseline through end of study. Approximately 28 months. ] [ Designated as safety issue: No ]
    Disease control as measured by the percentage of subjects whose best response was not progressive disease (PD) (ie, complete response (CR), partial response (PR), or stable disease (SD) per RECIST v.1.1). Stable disease will be included if it occurs at least 6 weeks after randomization


Estimated Enrollment: 373
Study Start Date: March 2014
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ruxolitinib plus regorafenib Drug: Ruxolitinib

5 mg tablets to be administered by mouth

Ruxolitinib 15mg BID (NOTE: Starting dose of randomized portion of study may be 10mg BID based on results from safety run-in study. Dose of ruxolitinib may be increased during randomized study, based on results from safety run-in.)

Other Names:
  • Jakafi ®
  • Jakavi ®
Drug: 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.)
Other Name: Stivarga ®
Active Comparator: Placebo plus regorafenib Drug: 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.)
Other Name: Stivarga ®
Drug: Placebo
5 mg matching placebo tablets to be administered by mouth

Detailed Description:

The study consists 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 will 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-VEGF therapy and if KRAS wild type an anti-EGFR therapy.

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the colon or rectum that is metastatic.
  • Progression after having been treated with fluoropyrimidine, oxaliplatin and irinotecan based chemotherapy, an anti-VEGF therapy and if KRAS wild type 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 1
  • Two 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.

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, 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02119676

Contacts
Contact: Incyte Corporation Call Center 1-855-463-3463

Locations
United States, Indiana
Recruiting
Lafayette, Indiana, United States
United States, Missouri
Recruiting
Jefferson City, Missouri, United States
United States, Ohio
Recruiting
Canton, Ohio, United States
United States, South Carolina
Recruiting
Charleston, South Carolina, United States
United States, Tennessee
Recruiting
Nashville, Tennessee, United States
Sponsors and Collaborators
Incyte Corporation
Investigators
Study Director: Lance Leopold, MD Incyte Corporation
  More Information

No publications provided

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT02119676     History of Changes
Other Study ID Numbers: INCB18424-267
Study First Received: April 17, 2014
Last Updated: June 2, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Incyte Corporation:
Metastatic Colorectal Cancer
Colon Cancer
Ruxolitinib
adenocarcinoma
regorafenib
Jakavi ®
Jakafi ®
Stivarga ®

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on October 01, 2014