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

Lilly

Status and phase: Completed; Phase 2

Conditions: Malignant Solid Tumor

Treatments: Drug: Gemcitabine; Drug: Cisplatin; Biological: Necitumumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01606748

14473

I4X-IE-JFCJ (Other Identifier)

CP11-1115 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Necitumumab, Gemcitabine and Cisplatin

Experimental group

Description:

The study will be conducted in two sequential periods: a 3-week PK run-in participants will be treated sequentially with single doses of cisplatin, gemcitabine, and necitumumab. Cycle 1 will begin immediately following the PK run-in period.

Treatment:

Drug: Cisplatin

Biological: Necitumumab

Drug: Gemcitabine