Clinical Trials /

Regorafenib + Panitumumab for Colorectal Cancers

NCT02199223

Description:

Evaluate the safety of regorafenib and panitumumab

Related Conditions:
  • Colorectal Carcinoma
Recruiting Status:

Terminated

Phase:

Phase 1

Trial Eligibility

Document

<span class="go-doc-concept go-doc-intervention">Regorafenib + Panitumumab</span> for Colorectal Cancers

Title

  • Brief Title: Regorafenib + Panitumumab for Colorectal Cancers
  • Official Title: Combination Study of Panitumumab and Regorafenib in Advanced or Metastatic KRAS and NRAS Wild Type Colorectal Cancers
  • Clinical Trial IDs

    NCT ID: NCT02199223

    ORG ID: HCI72561

    Trial Conditions

    KRAS and NRAS Wild-type Colorectal Cancer

    Trial Interventions

    Drug Synonyms Arms
    regorafenib + panitumumab panitumumab + regorafenib

    Trial Purpose

    Evaluate the safety of regorafenib and panitumumab

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    panitumumab + regorafenib Experimental regorafenib + panitumumab

    Eligibility Criteria

    Inclusion Criteria:

    - Histological diagnosis of un-resectable or metastatic colorectal cancer which is KRAS
    and NRAS mutation negative (wild-type) in codons 12, 13, 59, 61, 117 and 146.
    Mutations of KRAS and NRAS in other codons 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:

    - 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)

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Safety of regorafenib + panitumumab

    Secondary Outcome Measures

    Trial Keywords