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Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT01957995

Nanosomal Docetaxel Lipid Suspension in Treating Patients With Advanced Solid Tumors

A Phase 1 study testing nanosomal docetaxel lipid suspension and pharmacological study in people with Unspecified Adult Solid Tumor, Protocol Specific, run by University of Southern California at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 64 years
What is being tested?
nanosomal docetaxel lipid suspension and pharmacological study
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteUnited States
Study dates
8 Nov 2013to 14 Jul 2016
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
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  • 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
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 2.5X ULN if alkaline phosphatase < 2.5 ULN
  • AST/ALT < 1.5 X ULN if alkaline phosphatase > 2.5 ULN
  • Alkaline phosphatase must be < 5 x ULN on all cases

Who cannot join

  • 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
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  • 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
  • Pre-existing motor or sensory neurotoxicity of a severity >= grade 2 by National Cancer Institute (NCI) criteria
  • Positive hepatitis screening (hepatitis screen includes hepatitis B surface antigen [HBsAg], hepatitis C virus [HCV] and hepatitis A virus [HAV] [immunoglobulin M (IgM)] antibody)
  • Known case of active infection including human immunodeficiency virus (HIV) infections
  • Any other condition that, in the investigator's judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study
  • Abnormal baseline findings considered by the investigator to indicate conditions that might affect study endpoints
  • Donation of blood (1 unit or 350 mL) within 90 days prior to receiving the first dose of study medicine
  • Known, existing uncontrolled coagulopathy

Trial locations and contacts

1 site in 1 country.

United States1 site

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

Other trials in United States

About this study

Official title: An Open Label, Randomized Study to Evaluate Safety and Pharmacokinetics of Intravenous Infusion of Nanosomal Docetaxel Lipid Suspension for Injection in Patients With Advanced Solid Tumors

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To assess the pharmacokinetics profile of nanosomal docetaxel lipid suspension (NDLS) in patients with advanced solid tumors.

SECONDARY OBJECTIVES:

  1. To assess the safety and toxicity of NDLS in patients with advanced solid tumors.

OUTLINE: Patients are randomized to 1 of 4 treatment arms.

ARM I: Patients receive lowest dose nanosomal docetaxel lipid suspension intravenously (IV) over 1 hour.

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

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

ARM IV: Patients receive highest dose nanosomal docetaxel lipid suspension IV over 1 hour. In all arms, treatment may repeat every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 30 days.

Being tested
nanosomal docetaxel lipid suspension, pharmacological study

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01957995
Study groupRoleWhat they receive
Arm I (lowest dose NDLS)ExperimentalPatients receive lowest dose nanosomal docetaxel lipid suspension IV over 1 hour.
Receives: Drug: nanosomal docetaxel lipid suspension; Other: pharmacological study
Arm II (low dose NDLS)ExperimentalPatients receive low dose nanosomal docetaxel lipid suspension IV over 1 hour.
Receives: Drug: nanosomal docetaxel lipid suspension; Other: pharmacological study
Arm III (high dose NDLS)ExperimentalPatients receive high dose nanosomal docetaxel lipid suspension IV over 1 hour.
Receives: Drug: nanosomal docetaxel lipid suspension; Other: pharmacological study
Arm IV (highest dose NDLS)ExperimentalPatients receive highest dose nanosomal docetaxel lipid suspension IV over 1 hour.
Receives: Drug: nanosomal docetaxel lipid suspension; Other: pharmacological study

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2013 (estimated)
  2. Study start8 Nov 2013
  3. Primary completion29 May 2014
  4. Study completion14 Jul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01957995
Sponsor's protocol ID
0C-13-2
Other IDs
NCI-2013-01731, 022-13, 0C-13-2, P30CA014089
Status last verified
Apr 2017
First submitted
4 Oct 2013
Last updated
11 Apr 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing nanosomal docetaxel lipid suspension and pharmacological study in people with Unspecified Adult Solid Tumor, Protocol Specific, run by University of Southern California at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetic profile of nanosomal docetaxel lipid suspension (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01957995.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2017.

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