Dose Escalation and Pharmacokinetic Study of Paclitaxel Liposome Injection in Treating Patients With Advanced Solid Tumor After Failure From Conventional Treatments
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ClinicalTrials.gov Identifier: NCT01994031 |
Recruitment Status : Unknown
Verified August 2014 by Nanjing Luye Sike Pharmaceutical Co., Ltd..
Recruitment status was: Recruiting
First Posted : November 25, 2013
Last Update Posted : August 27, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Solid Tumors | Drug: Paclitaxel liposome injection Drug: Paclitaxel injection | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 36 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Dose Escalation and Pharmacokinetic Study of Paclitaxel Liposome Injection in Treating Patients With Advanced Solid Tumor After Failure From Conventional Treatments |
Study Start Date : | August 2014 |
Estimated Primary Completion Date : | July 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: Dose level A
Paclitaxel liposome injection 135mg/m2 on day 1, First cycle 28 days and subsequent cycles each 21 days
|
Drug: Paclitaxel liposome injection
Other Name: LIPUSU® |
Experimental: Dose level B
Paclitaxel liposome injection 175mg/m2 on day 1, First cycle 28 days and subsequent cycles each 21 days
|
Drug: Paclitaxel liposome injection
Other Name: LIPUSU® |
Experimental: Dose level C
Paclitaxel liposome injection 210mg/m2 on day 1, First cycle 28 days and subsequent cycles each 21 days
|
Drug: Paclitaxel liposome injection
Other Name: LIPUSU® |
Experimental: Dose level D
Paclitaxel liposome injection 250mg/m2 on day 1, First cycle 28 days and subsequent cycles each 21 days
|
Drug: Paclitaxel liposome injection
Other Name: LIPUSU® |
Experimental: Dose level E
Paclitaxel liposome injection 300mg/m2 on day 1, First cycle 28 days and subsequent cycles each 21 days
|
Drug: Paclitaxel liposome injection
Other Name: LIPUSU® |
Active Comparator: Comparator
Paclitaxel injection 175mg/m2 on day 1, each 21 days
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Drug: Paclitaxel injection
Other Name: Taxol® |
- 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)
- dose-limiting toxicities(DLTs) 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)
- Pharmacokinetic characters of paclitaxel liposome injection compared with paclitaxel injection [ Time Frame: 0,during infusion 1.5h, 3h, after infusion 15min, 30min, 1h,2h,4h,8h,12h,24h,36h,48h,72 h ]Peak Plasma Concentration(Cmax), peak time (Tmax), Half life(T1/2), Area under the plasma concentration versus time curve(AUC0-t), Clearance (CL/F), Apparent volume of distribution(Vd/F), Mean Residence Time (MRT),

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01994031
Contact: Jifang Gong, MD | 008601088196561 | goodjf@163.com |
China, Beijing | |
Peking Union Medical College Hospital | Recruiting |
Beijing, Beijing, China, 100032 | |
Contact: Ji Jiang | |
Beijing Cancer Hospital | Recruiting |
Beijing, Beijing, China, 100142 | |
Contact: Jifang Gong 00861088196561 goodjf@163.com | |
No.52 Fucheng Road, Haidian District,Beijing, | Not yet recruiting |
Beijing, Beijing, China, 100142 | |
Contact: Jifang Gong 008601088196561 goodjf@163.com | |
Principal Investigator: Lin Shen |
Responsible Party: | Nanjing Luye Sike Pharmaceutical Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT01994031 |
Other Study ID Numbers: |
NJLYSK-LPS-2013-01 |
First Posted: | November 25, 2013 Key Record Dates |
Last Update Posted: | August 27, 2014 |
Last Verified: | August 2014 |
paclitaxel liposome injection paclitaxel |
Neoplasms Paclitaxel Albumin-Bound Paclitaxel Antineoplastic Agents, Phytogenic Antineoplastic Agents |
Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |