a drug-interaction study of necitumumab (imc-11f8) in combination with gemcitabine-cisplatin

Conditions: Malignant Solid Tumor

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

Keywords: advanced malignant solid tumors solid cancers non-small cell lung cancer nsclc breast cancer