CancerPhase 4LPS-PK-HNCT00606515
Pharmacokinetics Study of Liposomal Paclitaxel in Humans
A Phase 4 study testing Liposomal paclitaxel and Paclitaxel in people with Cancer, run by Shandong Luye Pharmaceutical Co., Ltd. at 2 sites in China.
Trial summary
The purpose of this study is to determine whether there is any difference of the pharmacokinetics of two taxane formulations, paclitaxel injection and liposomal paclitaxel in Chinese cancer patients with solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cancer
- What is being tested?
- Liposomal paclitaxel and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesChina
- Study dates
- Feb 2008to Oct 2008
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible patients must have histologically confirmed solid tumors of advanced stages
- Patients who are suitable for being treated with liposomal paclitaxel only
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
- Patients who are expected to be alive for at least 3 months
- Adequate hematologic, hepatic and renal functions
- Adequate other organ functions as defined by the protocol
- No prior systemic chemotherapy at least 4 weeks before the recruitment
- No previous anaphylactic reaction to hormone.
Who cannot join
- Allergy to any study medication
- Serious complication that would compromise the patient's ability to complete the study
- Grade ≥1 neuropathy using NCI CTCAE version 3.0 criteria
- Pregnancy or breast feeding
Trial locations and contacts
2 sites in 1 country.
China2 sites
Cancer Hospital of Fudan University
Shanghai, Shanghai Municipality, 200032
Cancer Hospital of Fudan University
Shanghai, 200032
About this study
Official title: A Clinical Trial to Compare the Pharmacokinetics of Two Formulations of Taxane, Paclitaxel Injection and Liposomal Paclitaxel, in Humans
The purpose of this study is to determine whether there is any difference of the pharmacokinetics of two taxane formulations, paclitaxel injection and liposomal paclitaxel in Chinese cancer patients with solid tumors.
Read the detailed description
The pharmacokinetics of a new formulation of taxane (liposomal paclitaxel) has never been studied in Chinese cancer patients. This clinical trial is designed to find out the pharmacokinetics of liposomal paclitaxel at the dose of 175mg/m2 and whether it has a different pharmacokinetic profile to paclitaxel.
- Conditions
- Cancer
- Being tested
- Liposomal paclitaxel, Paclitaxel
- Keywords
- Pharmacokinetics, Liposomal paclitaxel
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal paclitaxelDrug
Patients will be given Liposomal paclitaxel intravenously in 3 hours with the dose of 175mg/m2 at the first day of chemotherapy. Cycle duration will be 21 days. Each patient will receive 3 cycles of therapy.
PaclitaxelDrug
Patients will be given paclitaxel intravenously in 3 hours with the dose of 175mg/m2 at the first day of chemotherapy. Cycle duration will be 21 days. Each patient will receive 3 cycles of therapy.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Liposomal paclitaxel Receives: Drug: Liposomal paclitaxel |
| B | Active comparator | Paclitaxel Receives: Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameters
Measured: 72 hours after the infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Luye Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nanjing Sike Pharmaceutical Co., Ltd.
- Investigators
- Jin Li, Doctor, Principal investigator, Cancer Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00606515
- Sponsor's protocol ID
- LPS-PK-01-2008
- Acronym
- LPS-PK-H
- Status last verified
- Feb 2009
- First submitted
- 21 Jan 2008
- Last updated
- 10 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Compare the Pharmacokinetics of Two Formulations of Taxane, Paclitaxel Injection and Liposomal Paclitaxel, in Humans
- ClinicalTrials.gov ID
- NCT00606515
- Acronym / sponsor ID
- LPS-PK-H / LPS-PK-01-2008
- Conditions
- Cancer
- Keywords
- Pharmacokinetics, Liposomal paclitaxel
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Shandong Luye Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Nanjing Sike Pharmaceutical Co., Ltd.
- Study start
- Feb 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 4 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether there is any difference of the pharmacokinetics of two taxane formulations, paclitaxel injection and liposomal paclitaxel in Chinese cancer patients with solid tumors.
Detailed description
The pharmacokinetics of a new formulation of taxane (liposomal paclitaxel) has never been studied in Chinese cancer patients. This clinical trial is designed to find out the pharmacokinetics of liposomal paclitaxel at the dose of 175mg/m2 and whether it has a different pharmacokinetic profile to paclitaxel.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Liposomal paclitaxelLiposomal paclitaxel |
| B | Active comparator | Drug: PaclitaxelPaclitaxel |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Eligible patients must have histologically confirmed solid tumors of advanced stages
- Patients who are suitable for being treated with liposomal paclitaxel only
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
- Patients who are expected to be alive for at least 3 months
- Adequate hematologic, hepatic and renal functions
Key exclusion criteria (4 listed)
- Allergy to any study medication
- Serious complication that would compromise the patient's ability to complete the study
- Grade ≥1 neuropathy using NCI CTCAE version 3.0 criteria
- Pregnancy or breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liposomal paclitaxelPatients will be given Liposomal paclitaxel intravenously in 3 hours with the dose of 175mg/m2 at the first day of chemotherapy. Cycle duration will be 21 days. Each patient will receive 3 cycles of therapy. | Drug | A |
| PaclitaxelPatients will be given paclitaxel intravenously in 3 hours with the dose of 175mg/m2 at the first day of chemotherapy. Cycle duration will be 21 days. Each patient will receive 3 cycles of therapy. | Drug | B |
Primary outcome
Pharmacokinetic parameters
Time frame: 72 hours after the infusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin Li, Doctor principal investigator
Cancer Hospital of Fudan University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Liposomal paclitaxel and Paclitaxel in people with Cancer, run by Shandong Luye Pharmaceutical Co., Ltd. at 2 sites in China.
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 8 inclusion and 4 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 10 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 parameters (time frame: 72 hours after the infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2009.