Dosing Study of Amino Acids in Seriously Ill Patients

• Status: Terminated
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the best rate of infusion of amino acids (15% CLINISOL - sulfite-free (Amino Acid) Injection) for nutrition in subjects with with stages II to IVB head and neck cancer.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baxter Healthcare Corporation

Criteria

Inclusion Criteria:

• Have Stages II to IVB head and neck cancer receiving radiation and may also be receiving chemotherapy.

• Subjects are eligible for inclusion in the study regardless of primary Stages II to IVB head and neck cancer treatment modality (eg, surgery, chemotherapy).

• Have voluntarily signed and dated a written informed consent form (ICF) after the nature of the study was explained to them.

• Female subjects must be of non childbearing potential (defined as postmenopausal for at least 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy or hysterectomy]) or;

• Female subjects of childbearing potential must be using adequate contraception (practicing 1 of the following methods of birth control):

• total abstinence from sexual intercourse (minimum of 1 complete menstrual cycle before study entry),

• a vasectomized partner,

• contraceptives (oral, parenteral, or transdermal) for 3 consecutive months prior to study drug administration,

• intrauterine device (IUD), or

• double barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream).

• Female subjects must have a negative serum or urinary pregnancy test result at screening (serum specimen must be obtained within 14 days prior to baseline).

Exclusion Criteria:

• Had a loss of > 10% of body weight within the 3 month period prior to the study as noted in the subjects medical history chart.

• Have renal disease as determined by an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2.

• Have a hemoglobin level of < 9 g/dl.

• Have Stage 0, I, or IVC metastatic cancer.

• Have diabetes.

• Have any reason which, in the opinion of the Investigator, would prevent the subject from safely participating in the study.

• Have, in the opinion of the Investigator, a dependence on alcohol.

• Have, in the opinion of the Investigator, a dependence on illicit drugs.