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Regorafenib + Panitumumab for Colorectal Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02199223
Recruitment Status : Terminated (Slow accrual)
First Posted : July 24, 2014
Last Update Posted : September 22, 2016
Information provided by (Responsible Party):
University of Utah

Tracking Information
First Submitted Date  ICMJE June 30, 2014
First Posted Date  ICMJE July 24, 2014
Last Update Posted Date September 22, 2016
Study Start Date  ICMJE June 2014
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2014)
Safety of regorafenib + panitumumab [ Time Frame: Safety of the drug combination will be measured by number and severity of adverse events experienced while patients are on treatment which will be about 2-3 months if not more depending on the response to treatment. ]
safety of combination for duration of treatment
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Regorafenib + Panitumumab for Colorectal Cancers
Official Title  ICMJE Combination Study of Panitumumab and Regorafenib in Advanced or Metastatic KRAS and NRAS Wild Type Colorectal Cancers
Brief Summary Evaluate the safety of regorafenib and panitumumab
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE KRAS and NRAS Wild-type Colorectal Cancer
Intervention  ICMJE Drug: regorafenib + panitumumab
Study Arms  ICMJE Experimental: panitumumab + regorafenib
Intervention: Drug: regorafenib + panitumumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 2, 2016)
Original Estimated Enrollment  ICMJE
 (submitted: July 23, 2014)
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histological diagnosis of un-resectable or metastatic colorectal cancer which is KRAS and NRAS mutation negative (wild-type). Patients with any known mutation in KRAS or NRAS codons 12, 13, 59, 61, 117 or 146 will be excluded. Mutations of KRAS and NRAS codons not listed above are allowed. Biopsy of metastatic lesion is not required.
  • Patients must show signs of progression (by imaging, or tumor marker elevation) after being treated with a first line or greater treatment for their un-resectable or metastatic colorectal cancer.
  • Age 18 years or older.
  • ECOG Performance Status 0-1
  • Subjects must be able to understand and be willing to sign the written informed consent form. A signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure.
  • Acute toxic effects of all prior treatment have resolved to NCI-CTCAE v4.0 less than or equal to Grade 1 or baseline prior to beginning treatment. Alopecia (any grade) is allowed. Peripheral neuropathy less than or equal to Grade 2 is allowed.
  • Adequate bone marrow, renal and liver function as assessed by protocol laboratory requirements
  • Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug. Post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test.
  • Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the ICF until at least 3 months after the last dose of study drug. Highly effective contraception must be used (e.g. male condom with spermicidal, diaphragm with spermicidal, intra-uterine device) must be used by both sexes.
  • Subject must be able to swallow medication.
  • Measurable disease at screening by RECIST 1.1 criteria

Exclusion Criteria:

  • Any known mutation in KRAS or NRAS codons 12, 13, 59, 61, 117 or 146.
  • Prior use of regorafenib.
  • Known or suspected grade 3 allergy or hypersensitivity to any of the study drugs, study drug classes, or excipients of the formulations given during the course of the trial.
  • Uncontrolled hypertension (systolic pressure greater than140 mm Hg or diastolic pressure greater than 90 mm Hg [NCI-CTCAE v4.0] on mean of 3 consecutive readings despite optimal medical management. Hypertension may be corrected by adding or adjusting anti-hypertensives prior to the initiation of treatment at the discretion of the practitioner.
  • Active or clinically significant cardiac disease including congestive heart failure, uncontrolled cardiac arrhythmias, or unstable angina.
  • Evidence or history of congenital or acquired hypocoagulability disorders.
  • Any hemorrhage or bleeding event greater than or equal to NCI CTCAE v.4.0 Grade 3 within 4 weeks prior to start of study medication.
  • Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks) deep vein thrombosis or pulmonary embolism that have initiated within 6 months of start of study treatment. Stable, persistent events under appropriate management diagnosed greater than 6 months prior to treatment are allowed at the discretion of the investigator.
  • Subjects who are receiving treatment for a concurrent cancer that is distinct in primary site or histology from colorectal carcinoma, except any cancer in-situ, treated basal cell or squamous cell carcinoma, or superficial bladder tumor. Subjects surviving a cancer that was curatively treated and without evidence of disease more than 1 year before randomization are allowed. All cancer treatments must be completed at least 1 year prior to start of study treatment.
  • Patients with severe hepatic impairment (Child-Pugh Class C).
  • Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy. Baseline testing is not required.
  • Patients requiring IV antiviral or IV antibiotic treatment for ongoing infections.
  • Symptomatic metastatic brain or meningeal tumors. Baseline brain imaging is not required.
  • Presence of a non-healing wound or bone fracture.
  • Patient's with a history of kidney disease or persistent proteinuria must have less than Grade 3 proteinuria per NCI CTCAE v4.0 at screening. If a patient has a history of kidney disease or persistent proteinuria, a urine protein test will be performed on a random urine sample. If the result is normal then no additional testing is required. If the result is abnormal, a 24 hour urine will be collected to determine if proteinuria is less than Grade 3.
  • Interstitial lung disease with ongoing signs and symptoms at the time of informed consent.
  • Any malabsorption condition that in the opinion of the investigator would significantly impact drug absorption.
  • Women who are pregnant or breast-feeding.
  • Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation.
  • Substance abuse, medical, psychological or social conditions that in the opinion of the investigator may interfere with the subject's participation in the study or evaluation of the study results.
  • Concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) within 3 weeks of starting study treatment.
  • Concurrent use of another investigational drug or device during, or within 3 weeks of starting study treatment.
  • Major surgical procedure, open biopsy, or significant traumatic injury within 3 weeks before start of study medication.
  • Concurrent use of strong CYP3a4 inducers (e.g. rifampin, phenytoin, carbamazepine, phenobarbital, and St. John's Wort)
  • Concurrent use with strong inhibitors of CYP3A4 (e.g. clarithromycin, grapefruit juice, itraconazole, ketoconazole, nefazadone, posaconazole, telithromycin, and voriconazole)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02199223
Other Study ID Numbers  ICMJE HCI72561
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University of Utah
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Utah
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Utah
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP