A Drug-Interaction Study of Necitumumab (IMC-11F8) in Combination With Gemcitabine-Cisplatin

Completed · Phase 2

Conditions studied: Malignant Solid Tumor

In brief

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.

Key facts

Study ID: NCT01606748
Run by: Eli Lilly and Company
People needed: 35
Starts: 2012-08-01
Expected to finish: 2016-06-01
Last updated by the study team: 2019-09-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

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, United States
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, United States
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, United States
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, United States

Full record on ClinicalTrials.gov

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