Solid TumorsPhase 4NCT01994031
Dose Escalation and Pharmacokinetic Study of Paclitaxel Liposome Injection in Treating Patients With Advanced Solid Tumor After Failure From Conventional Treatments
A Phase 4 study testing Paclitaxel liposome injection and Paclitaxel injection in people with Solid Tumors, run by Nanjing Luye Sike Pharmaceutical Co., Ltd. at 3 sites in China.
Trial summary
The purpose of this study is to determine the maximum tolerated dose (MTD)of paclitaxel liposome injection and to compare the pharmacokinetic characters between paclitaxel liposome injection and paclitaxel injection and to value the effectiveness for cancer treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumors
- What is being tested?
- Paclitaxel liposome injection and Paclitaxel injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 3 sitesChina
- Study dates
- Aug 2014to Jul 2015
- 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
- patient willing to sign an Investigational Review Board(IRB) approved written informed consent document
- patient age: 18 years -75years
- patient must have histologically confirmed solid tumor
- patient must have uncurable and unresectable solid tumor of advanced stages
- patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- patient must have a life expectancy at least 12 weeks
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- patient must have at least one lesion measurable according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.0
- patient must have progress or recurrence after at least one chemotherapy regimen for advanced stage
- patient must have adequate marrow,hepatic and renal function: defined as ANC≥2.0 × 109/L，PLT ≥10 ×109/dL, Hb ≥ 9g/dL;GOT/GPT≤2.5×ULN；Toltle bilirubin ≤1.5×ULN; Serum creatinine ≤1.5×ULN or Creatinine clearance≥40ml/min(according to Cockcroft-Gault；
- patient must have the left ventricular ejection fraction (LVEF)≥50% confirmed by ultrasonic heart scanning
- women must have the negative pregnancy test; women and men must agree to use adequate contraception
Who cannot join
- patient must non have received any other antitumor therapy, including chemotherapy, radiotherapy, hormonal therapy, biological therapy, immunotherapy and any other investigational agent within 4 weeks prior to starting study
- patient must non have any pre-existing toxity from prior antitumor therapy (any≥ grade 2, any≥1 peripheral neuropathy, excluding alopecia)
- patient must non have uncontrolled cerebral metastases
- patient must non have any uncontrolled heart illness including, but not limited to, ongoing symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, arterial hypertension (≥180/110), heart failure and myocardial infarction within 6 months prior to starting study
- Patient must not have a history of a malignancy tumor except for the following: adequately treated localized basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix for at least 5 years
- patient must non have any serious illness including, but not limited to hepatic, renal, respiratory and uncontrolled diabetes mellitus
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- patient must non have psychiatric illness/social situations that would limit compliance with study requirements.
- patient must non have active or uncontrolled infection including, but not limited to tuberculosis,HIV,HBV, HCV
- Patient must non be receiving any other antitumor agent
- patient must non be pregnant and/or breastfeeding
- patient must non be receiving protease inhibitors,inhibitors of CYP3A4,antifungal agents and inducing agent of CYP3A4
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100032
Ji Jiang
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Jifang Gong, 00861088196561, goodjf@163.com
- Not yet recruiting
No.52 Fucheng Road, Haidian District,Beijing,
Beijing, Beijing Municipality, 100142
Jifang Gong, 008601088196561, goodjf@163.com
Lin Shen
About this study
The purpose of this study is to determine the maximum tolerated dose (MTD)of paclitaxel liposome injection and to compare the pharmacokinetic characters between paclitaxel liposome injection and paclitaxel injection and to value the effectiveness for cancer treatment.
- Conditions
- Solid Tumors
- Being tested
- Paclitaxel liposome injection, Paclitaxel injection
- Keywords
- paclitaxel liposome injection, paclitaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel liposome injectionDrug
Also called LIPUSU®
Paclitaxel injectionDrug
Also called Taxol®
| Study group | Role | What they receive |
|---|---|---|
| Dose level A | Experimental | Paclitaxel liposome injection 135mg/m2 on day 1, First cycle 28 days and subsequent cycles each 21 days Receives: Drug: Paclitaxel liposome injection |
| Dose level B | Experimental | Paclitaxel liposome injection 175mg/m2 on day 1, First cycle 28 days and subsequent cycles each 21 days Receives: Drug: Paclitaxel liposome injection |
| Dose level C | Experimental | Paclitaxel liposome injection 210mg/m2 on day 1, First cycle 28 days and subsequent cycles each 21 days Receives: Drug: Paclitaxel liposome injection |
| Dose level D | Experimental | Paclitaxel liposome injection 250mg/m2 on day 1, First cycle 28 days and subsequent cycles each 21 days Receives: Drug: Paclitaxel liposome injection |
| Dose level E | Experimental | Paclitaxel liposome injection 300mg/m2 on day 1, First cycle 28 days and subsequent cycles each 21 days Receives: Drug: Paclitaxel liposome injection |
| Comparator | Active comparator | Paclitaxel injection 175mg/m2 on day 1, each 21 days Receives: Drug: Paclitaxel injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose(MTD)of paclitaxel liposome injection
Graded and described using National Cancer Institute(NCI)Common Terminology Criteria for adverse events (CTCAE 4.0)
Measured: completion of cycle 1(28 days)
Secondary outcomes (1)
dose-limiting toxicities(DLTs) of paclitaxel liposome injection
Graded and described using National Cancer Institute(NCI)Common Terminology Criteria for adverse events (CTCAE 4.0)
Measured: completion of cycle 1 (28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startAug 2014
- Primary completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Luye Sike Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01994031
- Sponsor's protocol ID
- NJLYSK-LPS-2013-01
- Status last verified
- Aug 2014
- First submitted
- 31 Oct 2013
- Last updated
- 27 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Escalation and Pharmacokinetic Study of Paclitaxel Liposome Injection in Treating Patients With Advanced Solid Tumor After Failure From Conventional Treatments
- ClinicalTrials.gov ID
- NCT01994031
- Acronym / sponsor ID
- NJLYSK-LPS-2013-01
- Conditions
- Solid Tumors
- Keywords
- paclitaxel liposome injection, paclitaxel
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Nanjing Luye Sike Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Jul 2015 (estimated)
- First posted
- 25 Nov 2013 (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 the maximum tolerated dose (MTD)of paclitaxel liposome injection and to compare the pharmacokinetic characters between paclitaxel liposome injection and paclitaxel injection and to value the effectiveness for cancer treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Dose level A | Experimental | Drug: Paclitaxel liposome injectionPaclitaxel liposome injection 135mg/m2 on day 1, First cycle 28 days and subsequent cycles each 21 days |
| Dose level B | Experimental | Drug: Paclitaxel liposome injectionPaclitaxel liposome injection 175mg/m2 on day 1, First cycle 28 days and subsequent cycles each 21 days |
| Dose level C | Experimental | Drug: Paclitaxel liposome injectionPaclitaxel liposome injection 210mg/m2 on day 1, First cycle 28 days and subsequent cycles each 21 days |
| Dose level D | Experimental | Drug: Paclitaxel liposome injectionPaclitaxel liposome injection 250mg/m2 on day 1, First cycle 28 days and subsequent cycles each 21 days |
| Dose level E | Experimental | Drug: Paclitaxel liposome injectionPaclitaxel liposome injection 300mg/m2 on day 1, First cycle 28 days and subsequent cycles each 21 days |
| Comparator | Active comparator | Drug: Paclitaxel injectionPaclitaxel injection 175mg/m2 on day 1, each 21 days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- patient willing to sign an Investigational Review Board(IRB) approved written informed consent document
- patient age: 18 years -75years
- patient must have histologically confirmed solid tumor
- patient must have uncurable and unresectable solid tumor of advanced stages
- patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Key exclusion criteria (11 listed)
- patient must non have received any other antitumor therapy, including chemotherapy, radiotherapy, hormonal therapy, biological therapy, immunotherapy and any other investigational agent within 4 weeks prior to starting study
- patient must non have any pre-existing toxity from prior antitumor therapy (any≥ grade 2, any≥1 peripheral neuropathy, excluding alopecia)
- patient must non have uncontrolled cerebral metastases
- patient must non have any uncontrolled heart illness including, but not limited to, ongoing symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, arterial hypertension (≥180/110), heart failure and myocardial infarction within 6 months prior to starting study
- Patient must not have a history of a malignancy tumor except for the following: adequately treated localized basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix for at least 5 years
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 |
|---|---|---|
| Paclitaxel liposome injectionAlso: LIPUSU® | Drug | Dose level A, Dose level B, Dose level C, Dose level D, Dose level E |
| Paclitaxel injectionAlso: Taxol® | Drug | Comparator |
Primary outcome
Maximum tolerated dose(MTD)of paclitaxel liposome injection
Time frame: completion of cycle 1(28 days)
Graded and described using National Cancer Institute(NCI)Common Terminology Criteria for adverse events (CTCAE 4.0)
1 secondary outcome
dose-limiting toxicities(DLTs) of paclitaxel liposome injection
Time frame: completion of cycle 1 (28 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2014.
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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.
3 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 Paclitaxel liposome injection and Paclitaxel injection in people with Solid Tumors, run by Nanjing Luye Sike Pharmaceutical Co., Ltd. at 3 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 11 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 27 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jifang Gong, MD (008601088196561, goodjf@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose(MTD)of paclitaxel liposome injection (time frame: completion of cycle 1(28 days)). 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 27 Aug 2014.