A Drug-Interaction Study of Necitumumab (IMC-11F8) in Combination With Gemcitabine-Cisplatin
Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Malignant Solid Tumor
Intervention: Necitumumab (Biological); Gemcitabine (Drug); Cisplatin (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Eli Lilly and Company Official(s) and/or principal investigator(s): Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study Director, Affiliation: Eli Lilly and Company
Summary
The purpose of this study is to investigate the pharmacokinetics (PK) of necitumumab in
combination with gemcitabine-cisplatin in patients with advanced malignant solid tumors and
to assess the potential for drug-drug interactions between necitumumab and
gemcitabine-cisplatin.
Clinical Details
Official title: An Open-Label, Non-controlled, Non-randomized Sequential Design, Drug-Interaction Study of Necitumumab (IMC-11F8) in Combination With Gemcitabine-Cisplatin in Patients With Advanced Solid Cancers
Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Pharmacokinetics: maximum observed drug concentration (Cmax) of necitumumab, gemcitabine, and cisplatinPharmacokinetics: area under concentration-time curve [AUC(0-t)] of necitumumab, gemcitabine, and cisplatin Pharmacokinetics: area under the plasma concentration-time curve from time zero to infinity [AUC(0-∞)] of gemcitabine and cisplatin
Secondary outcome: Incidence of anti-necitumumab antibodiesAntitumor activity of necitumumab in combination with gemcitabine-cisplatin chemotherapy (tumor response evaluated per the Response Evaluation Criteria in Solid Tumors, Version 1.1 [RECIST 1.1]) Pharmacokinetics: maximum observed drug concentration (Cmax) of necitumumab after administration of Process C and Process D drug product Pharmacokinetics: area under concentration-time curve [AUC(0-t)] of necitumumab after administration of Process C and Process D drug product
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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 patients 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 patient 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
Locations and Contacts
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 85258, 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 48202, 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 89169, 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 15213, United States
Additional Information
Starting date: August 2012
Last updated: March 30, 2015
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