Overview

This trial is active, not recruiting.

Condition malignant solid tumor
Treatments necitumumab, gemcitabine, cisplatin
Phase phase 2
Target EGFR
Sponsor Eli Lilly and Company
Start date August 2012
End date June 2013
Trial size 36 participants
Trial identifier NCT01606748, 14473, CP11-1115, I4X-IE-JFCJ

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification pharmacokinetics study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
The study will be conducted in two sequential periods: a 3-week PK run-in period and a combination treatment period. During the PK run-in period patients will be treated sequentially with single doses of cisplatin, gemcitabine, and necitumumab. Cycle 1 will begin immediately following the PK run-in period.
necitumumab IMC-11F8
PK Run-In Period: Necitumumab administered on Day 3 of the 3-week PK run-in period as an intravenous (I.V.) infusion at an absolute dose of 800 mg Treatment Cycles: Necitumumab administered on Days 1 and 8 of every 3-week cycle as an intravenous (I.V.) infusion at an absolute dose of 800 mg Patients in Cohort 1 will receive necitumumab Process C drug product and patients in Cohort 2 will receive necitumumab Process D drug product
gemcitabine Gemzar
PK Run-In Period: Gemcitabine administered on Day 1 of the 3-week PK run-in period as an I.V. infusion at a dose of 1250 mg/m2 Treatment Cycles: Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an I.V. infusion at a dose of 1250 mg/m2
cisplatin
PK Run-In Period: Cisplatin administered on Day 1 of the 3-week PK run-in period as an I.V. infusion at a dose of 75 mg/m2 Treatment Cycles: Cisplatin administered on Day 1 of every 3-week cycle as an I.V. infusion at a dose of 75 mg/m2

Primary Outcomes

Measure
Pharmacokinetics: maximum observed drug concentration (Cmax) of necitumumab, gemcitabine, and cisplatin
time frame: PK Run-in Period and Treatment Period: Predose, up to 168 hours post dose
Pharmacokinetics: area under concentration-time curve [AUC(0-t)] of necitumumab, gemcitabine, and cisplatin
time frame: PK Run-in Period and Treatment Period: Predose, up to 168 hours post dose
Pharmacokinetics: area under the plasma concentration-time curve from time zero to infinity [AUC(0-∞)] of gemcitabine and cisplatin
time frame: PK Run-in Period and Treatment Period: Predose, up to 168 hours post dose

Secondary Outcomes

Measure
Incidence of anti-necitumumab antibodies
time frame: Pretreatment, Day 1 of Cycle 1, 2, 4 and 6, and at 30-day follow-up
Antitumor 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])
time frame: Every 6 weeks post first dose
Pharmacokinetics: maximum observed drug concentration (Cmax) of necitumumab after administration of Process C and Process D drug product
time frame: PK Run-in Period and Treatment Period: Predose, up to 168 hours post dose
Pharmacokinetics: area under concentration-time curve [AUC(0-t)] of necitumumab after administration of Process C and Process D drug product
time frame: PK Run-in Period and Treatment Period: Predose, up to 168 hours post dose

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.