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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 cisplatin

Pharmacokinetics: 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 antibodies

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])

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

Page last updated: August 23, 2015

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