Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Malignant Solid Tumor

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pharmacokinetics: maximum observed drug concentration (Cmax) of necitumumab, gemcitabine, and cisplatin

Outcome Time Frame:

PK Run-in Period and Treatment Period: Predose, up to 168 hours post dose

Safety Issue:

No

Principal Investigator

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)

Investigator Role:

Study Director

Investigator Affiliation:

ImClone LLC

Authority:

United States: Food and Drug Administration

Study ID:

14473

NCT ID:

NCT01606748

Start Date:

August 2012

Completion Date:

June 2014

Related Keywords:

  • Malignant Solid Tumor
  • Advanced Malignant Solid Tumors
  • Solid Cancers
  • Non-small Cell Lung Cancer
  • NSCLC
  • Breast Cancer
  • Neoplasms

Name

Location

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.Kalamazoo, Michigan  49048
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
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.Dunmore, Pennsylvania  18512