EUCTR2013-004714-18-GB
Active, not recruiting
Phase 1
A Randomized, Double-Blind Study of Ruxolitinib or Placebo inCombination With Regorafenib in Subjects With Relapsed orRefractory Metastatic Colorectal Cancer - Ruxolitinib in Combination With Regorafenib in Metastatic Colorectal Cancer
ConditionsRelapsed or refractory metastatic colorectal cancerMedDRA version: 17.0Level: PTClassification code 10052358Term: Colorectal cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.0Level: PTClassification code 10010030Term: Colorectal cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.0Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.0Level: PTClassification code 10061451Term: Colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Relapsed or refractory metastatic colorectal cancer
- Sponsor
- Incyte Corporation
- Enrollment
- 420
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female 18 years or older.
- •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; and progressed following the last administration of approved therapy.
- •Radiographically measurable or evaluable disease (per RECIST 1\.1\).
- •Eastern Cooperative Oncology Group 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.
- •Radiotherapy to disease sites is allowed provided:
- •\- Four or more weeks have elapsed since the completion of radiation therapy.
- •\- Subjects who received palliative radiation treatment to a limited field or on an accelerated schedule within the last 7 days are eligible
- •\- Disease sites within the field of prior irradiation have subsequently progressed or there are other metastatic disease sites outside the field of prior irradiation.
Exclusion Criteria
- •Subjects who meet any of the following will not be included in the study:
- •Received prior treatment with regorafenib.
- •Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption of drugs.
- •History of abdominal fistula or gastrointestinal perforation at any point within 6 months prior to day 1 of study drug administration, unless surgically repaired.
- •Active peptic ulcer disease, inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease), diverticulitis, or other gastrointestinal conditions with increased risk of perforation or gastrointestinal bleeding.
- •Recent history (\=4 weeks of Day 1 of study drug administration) of a major surgery or significant traumatic injury.
- •Recent history (\= 3 months) or ongoing partial or complete bowel obstruction unless corrected with surgery.
- •Blood pressure \= 140/90 mmHg
- •Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment.
- •Known central nervous system metastases or history of uncontrolled seizures.
Outcomes
Primary Outcomes
Not specified
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