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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
Sponsor:
Information provided by (Responsible Party):
Nanjing Luye Sike Pharmaceutical Co., Ltd.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: Paclitaxel liposome injection Drug: Paclitaxel injection Phase 4

Study Design
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Arms and Interventions
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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
 Drug: Paclitaxel injection
Other Name: Taxol®


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)


Other Outcome Measures:
  1. 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),


Eligibility Criteria
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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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Jifang Gong, MD 008601088196561 goodjf@163.com

Locations
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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         
Sponsors and Collaborators
Nanjing Luye Sike Pharmaceutical Co., Ltd.
More Information
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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
Keywords provided by Nanjing Luye Sike Pharmaceutical Co., Ltd.:
paclitaxel liposome injection
paclitaxel
Additional relevant MeSH terms:
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Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
 Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action