A Drug-Interaction Study of Necitumumab (IMC-11F8) in Combination With Gemcitabine-Cisplatin
Condition: Malignant Solid Tumor
MeSH terms: Neoplasms
Intervention: Necitumumab; Gemcitabine; Cisplatin
Intervention description: PK Run-In Period: Necitumumab administered on Day 3 of the 3-week PK run-in period as an intravenous (I.V.) infusion at an absolute dose of 800 mg
Treatment Cycles: Necitumumab administered on Days 1 and 8 of every 3-week cycle as an intravenous (I.V.) infusion at an absolute dose of 800 mg
Participants in Cohort 1 will receive necitumumab Process C drug product and participants in Cohort 2 will receive necitumumab Process D drug product; PK Run-In Period: Gemcitabine administered on Day 1 of the 3-week PK run-in period as an I.V. infusion at a dose of 1250 milligram per square meter (mg/m2)
Treatment Cycles: Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an I.V. infusion at a dose of 1250 mg/m2; PK Run-In Period: Cisplatin administered on Day 1 of the 3-week PK run-in period as an I.V. infusion at a dose of 75 mg/m2
Treatment Cycles: Cisplatin administered on Day 1 of every 3-week cycle as an I.V. infusion at a dose of 75 mg/m2
Intervention MeSH terms: Gemcitabine; Necitumumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced Malignant Solid Tumors; Solid Cancers; Non-small Cell Lung Cancer; NSCLC; Breast Cancer

Summary:

      The purpose of this study is to investigate the pharmacokinetics (PK) of necitumumab in
      combination with gemcitabine-cisplatin in participants with advanced malignant solid tumors
      and to assess the potential for drug-drug interactions between necitumumab and
      gemcitabine-cisplatin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have documented advanced or metastatic malignant solid tumors (except for colorectal
             tumors with KRAS mutation) that are resistant to standard therapy or for which no
             standard therapy is available

          -  May have measurable or non-measurable disease

          -  Have resolution to Grade 0 or 1 by the National Cancer Institute Common Terminology
             Criteria for Adverse Events, Version 4.0 (NCI-CTCAE 4.0) of all clinically significant
             toxic effects (other than alopecia) of prior chemotherapy, surgery, radiotherapy, or
             hormonal therapy

          -  Have an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or
             1

          -  Have adequate hepatic, hematologic and renal function

          -  If female, are surgically sterile, postmenopausal, or agree to be compliant with a
             highly effective contraceptive method during and for 6 months after the treatment
             period. If male, are surgically sterile or agree to be compliant with a highly
             effective contraceptive regimen during and for 6 months after the treatment period

          -  Female participants of childbearing potential have a negative serum pregnancy test
             within 7 days prior to the first dose of study therapy

        Exclusion Criteria:

          -  Have received a systemic anticancer agent (including EGFR tyrosine kinase inhibitors)
             or device within 28 days prior to first dose of study therapy

          -  The most recent anticancer therapy received by the participant included either
             gemcitabine or cisplatin (or both)

          -  Have received radiotherapy within 14 days prior to first dose of study therapy

          -  Have received cytotoxic chemotherapy within 21 days prior to first dose of study
             therapy

          -  Are receiving concurrent treatment with another anticancer therapy, including
             chemotherapy, immunotherapy, hormonal therapy, radiation therapy, chemoembolization,
             or targeted therapy

          -  Are considered surgical candidates (with resectable disease)

          -  Have brain metastases that are symptomatic or require ongoing treatment with steroids
             or anticonvulsants

          -  Have narrowing of or blockage in large veins

          -  Have coronary artery disease or uncontrolled congestive heart failure

          -  Have uncontrolled angina pectoris, or experienced myocardial infarction within 6
             months prior to first dose of study therapy

          -  Have an ongoing or active infection (requiring treatment), including active
             tuberculosis or known infection with the human immunodeficiency virus

          -  Have a history of significant neurological or psychiatric disorders, including
             dementia, seizures, or bipolar disorder

          -  Have known drug or alcohol abuse

          -  If female, are pregnant or breastfeeding

          -  Have had major surgery within 28 days prior to first dose of study medication or
             subcutaneous venous access device implantation within 7 days prior to first dose of
             study therapy

          -  Are currently enrolled in, or discontinued within the 30 days prior to first dose of
             study therapy from a clinical trial involving an investigational product or
             nonapproved use of a drug or device, or concurrently enrolled in any other type of
             medical research judged not to be scientifically or medically compatible with this
             study