Nanosomal Docetaxel Lipid Suspension in Treating Patients With Advanced Solid Tumors

NCT01957995 | Completed Phase 1 DMC

• 4 other identifiers: 0C-13-2NCI-2013-01731022-13P30CA014089
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized phase I trial studies the side effects and best dose of nanosomal docetaxel lipid suspension in treating patients with advanced solid tumors. Drugs used in chemotherapy, such as nanosomal docetaxel lipid suspension, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic profile of nanosomal docetaxel lipid suspension

  Descriptive statistics of all pharmacokinetic parameters would be computed and reported for free and total docetaxel. Maximum blood concentration (Cmax), area under the curve (AUC)0-t, AUC0-infinity, time to Cmax (Tmax), terminal elimination rate constant (lambda z), half-life (t1/2), AUC percent extrapolated (%Extrap), clearance (CL), and volume of distribution (Vd) will be calculated.

  Pre-dose and post dose at 10, 20, 30, 40, 50, 60, 80, and 100 minutes and 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, and 48 hours

Study Arms (4)

Arm I (lowest dose NDLS)

EXPERIMENTAL

Patients receive lowest dose nanosomal docetaxel lipid suspension IV over 1 hour.

Drug: nanosomal docetaxel lipid suspension; Other: pharmacological study

Arm II (low dose NDLS)

EXPERIMENTAL

Patients receive low dose nanosomal docetaxel lipid suspension IV over 1 hour.

Drug: nanosomal docetaxel lipid suspension; Other: pharmacological study

Arm III (high dose NDLS)

EXPERIMENTAL

Patients receive high dose nanosomal docetaxel lipid suspension IV over 1 hour.

Drug: nanosomal docetaxel lipid suspension; Other: pharmacological study

Arm IV (highest dose NDLS)

EXPERIMENTAL

Patients receive highest dose nanosomal docetaxel lipid suspension IV over 1 hour.

Drug: nanosomal docetaxel lipid suspension; Other: pharmacological study

Interventions

nanosomal docetaxel lipid suspension DRUG

Given IV

Arm I (lowest dose NDLS); Arm II (low dose NDLS); Arm III (high dose NDLS); Arm IV (highest dose NDLS)

pharmacological study OTHER

Correlative studies

Arm I (lowest dose NDLS); Arm II (low dose NDLS); Arm III (high dose NDLS); Arm IV (highest dose NDLS)

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Must have given written, personally signed and dated, informed consent to participate in the study before initiating any study related procedures
• Body mass index (BMI) at least 17 calculated as weight in kg/height in m\^2
• Must have histopathologically/cytologically confirmed primary tumors for which docetaxel is an appropriate or reasonable treatment option
• Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
• Must have recovered from any toxic effects of previous chemotherapy or radiotherapy as judged by the investigator to =\< grade 1
• Previous chemotherapy/radiotherapy/targeted therapy should have been completed at least 4 weeks prior to start of NDLS administration
• Life expectancy of at least 6 months
• Female patients of child bearing potential must have negative serum pregnancy test at screening
• Sexually active women, unless surgically sterile (at least 6 months prior to study drug administration) or postmenopausal for at least 12 consecutive months, must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives \[any hormonal method in conjunction with a secondary method\], intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile \[at least 6 months prior to study drug administration\] sexual partner) for at least 4 weeks prior to study drug administration, during study and up to 30 days after the last dose of study drug; cessation of birth control after this point should be discussed with a responsible physician
• In case of male patients: either patient partners or patients themselves must use an effective method of avoiding pregnancy for at least 4 weeks prior to study drug administration, during study and up to 30 days after the last dose of study drug or till next chemotherapy cycle
• Absolute neutrophil count (ANC) \>= 1500/mm\^3
• Platelet count \>= 100,000/mm\^3
• Hemoglobin \>= 9 gm/dl
• Serum creatinine \< 1.5 times upper limit of normal (ULN)
• Total bilirubin =\< ULN

You may not qualify if:

• Hypersensitivity to docetaxel injection or any of its excipients
• Intolerance to any antineoplastic agents belonging to the taxane family
• Prior anticancer therapy within 28 days prior to the first day of study treatment
• Participation in another experimental drug study within 30 days prior signing the informed consent form (ICF)
• Any of the following cardiac conditions:
• Unstable angina
• Myocardial infarction within the past 6 months
• New York State Heart Association (NYHA) class II-IV heart failure
• Uncontrolled angina
• Severe uncontrolled ventricular arrhythmias
• Clinically significant pericardial disease
• Electrocardiographic evidence of acute ischemic or active conduction system abnormalities
• Evidence of abnormal cardiac conduction (e.g., bundle branch block or heart block) are eligible if their disease has been stable for the past six months \* History of cardiac disease that met the NYHA classification class 2 or greater
• Use of any recreational drugs or history of drug addiction
• Known history of brain metastasis

Sponsors & Collaborators

• University of Southern California: lead
• Jina Pharmaceuticals Inc.: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Study Officials

• Anthony El-Khoueiry

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2013
• First Posted: October 8, 2013
• Study Start: November 8, 2013
• Primary Completion: May 29, 2014
• Study Completion: July 14, 2016
• Last Updated: April 11, 2017

Record last verified: 2017-04

Locations

US (1)