CompletedPhase 2NCT01606748

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

StatusCompleted
PhasePhase 2
U.S. locations4
SponsorEli Lilly and Company
01
Study overview

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
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach
03
Public criteria

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.

04
Study sites

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.

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