A Drug-Interaction Study of Necitumumab (IMC-11F8) in Combination With Gemcitabine-Cisplatin
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.
Checked against the public recordLast updated Sep 30, 2019 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Eli Lilly and Company
- Interventions being studied
- Biological: Necitumumab; Drug: Gemcitabine; Drug: Cisplatin
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Scottsdale, Arizona
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Detroit, Michigan
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Las Vegas, Nevada
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Pittsburgh, Pennsylvania
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 30, 2019. Always confirm current availability with the study team.