Clinical Trials /

A Phase I Study of Nilontinib and Cetuximab in Patients With Solid Tumors

NCT01871311

Description:

The purpose of this study is to determine the recommended Phase II dose of nilotinib when used in combination with cetuximab in the treatment of patients with recurrent and/or metastatic Kras wildtype colorectal cancer or squamous cell carcinoma of the head and neck.

Related Conditions:
  • Colorectal Carcinoma
  • Head and Neck Squamous Cell Carcinoma
Recruiting Status:

Terminated

Phase:

Phase 1

Trial Eligibility

Document

A Phase I Study of Nilontinib and <span class="go-doc-concept go-doc-intervention">Cetuximab</span> in Patients With Solid Tumors

Title

  • Brief Title: A Phase I Study of Nilontinib and Cetuximab in Patients With Solid Tumors
  • Official Title: A Phase I Study of the BCR-ABL Tyrosine Kinase Inhibitor Nilontinib and Cetuximab in Patients With Solid Tumors That Can be Treated With Cetuximab
  • Clinical Trial IDs

    NCT ID: NCT01871311

    ORG ID: 2013-0039

    Trial Conditions

    Colorectal Cancer

    Head and Neck Cancer

    Trial Interventions

    Drug Synonyms Arms
    Nilotinib + Cetuximab Nilotinib + Cetuximab

    Trial Purpose

    The purpose of this study is to determine the recommended Phase II dose of nilotinib when
    used in combination with cetuximab in the treatment of patients with recurrent and/or
    metastatic Kras wildtype colorectal cancer or squamous cell carcinoma of the head and neck.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Nilotinib + Cetuximab Experimental All patients with receive Nilotinib BID for a 28-day cycle + Cetuximab 400 mg/m2 on day 1 dose then 250 mg/m2 weekly Nilotinib + Cetuximab

    Eligibility Criteria

    Inclusion Criteria:

    1. Recurrent and/or metastatic Kras wildtype colorectal cancer or squamous cell
    carcinoma of the head and neck

    2. Previous therapy:

    1. Patients must have progressed after standard therapy for metastatic/recurrent
    disease, including irinotecan and oxaliplatin-containing regimens for patients
    with CRC and platinum-containing regimens for patients with H&NSCC.

    2. Patients may have received cetuximab or panitumumab previously

    3. Ability to swallow medication tablets by mouth (which may include taking nilotinib
    mixed in apple sauce)

    4. At least one measurable lesion by RECIST criteria

    5. A tumor lesion that can be readily biopsied using a core needle via clinical exam or
    image-guidance.

    6. Over the age of 18 years and able to provide informed consent

    7. Adequate kidney, liver, and bone marrow function as follows:

    1. Hemoglobin >/= 8.0 gm/dL

    2. Absolute neutrophil count >/= 1500

    3. Platelet count >/= 100,000

    4. Creatinine within institutional normal limits or glomerular filtration rate > 60

    5. Total bilirubin f. AST and ALT

    8. Life expectancy of greater than 3 months

    9. ECOG performance status

    10. Normal left ventricular ejection fraction, defined as EF > 50%

    Exclusion Criteria:

    1. Chemotherapy or surgery within 4 weeks prior to treatment start

    2. Radiation treatment within 3 weeks prior to treatment start

    3. Prior therapy with nilotinib, ponatinib, dasatinib, or imatinib

    4. Untreated brain metastases or neurologically unstable central nervous system
    metastases; CNS metastases will be considered stable if there is no new nor enlarging
    lesions for one month, and the patient remains off steroids and anti-epileptics for
    the same time period

    5. Any severe or uncontrolled medical condition or other condition that could affect
    participation in this study, including: unstable angina, uncontrolled hypertension,
    serious uncontrolled cardiac arrhythmia, uncontrolled infection, or myocardial
    infarction

    6. Diarrhea > Grade 1 at baseline

    7. Concomitant medication or herbal therapy known to inhibit CYP3A4

    8. Gastrointestinal tract disease resulting in the inability to take oral medication or
    a requirement for IV alimentation, prior surgical procedures affecting absorption, or
    active peptic ulcer disease

    9. Ongoing ventricular cardiac dysrhythmias of NCI CTCAE grade >/= 2

    10. Subjects with a history of serious ventricular arrhythmia (ventricular tachycardia or
    ventricular fibrillation >/= 3 beats in a row)

    11. Serious cardiac arrhythmia requiring medication

    12. QTc interval > 500 msec

    13. Female patients who are pregnant or breast feeding, or adults who are of reproductive
    potential and are unwilling to refrain from conceiving a child during study treatment

    14. Patients unwilling or unable to comply with the protocol, or provide informed consent

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Maximum tolerated dose

    Secondary Outcome Measures

    Trial Keywords

    metastatic Kras wildtype

    squamous cell carcinoma

    cetuximab

    nilotinib