Dose Escalation and Pharmacokinetic Study of Paclitaxel Liposome Injection in Treating Patients With Advanced Solid Tumor After Failure From Conventional Treatments
1 other identifier
interventional
36
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2013
CompletedFirst Posted
Study publicly available on registry
November 25, 2013
CompletedStudy Start
First participant enrolled
August 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedAugust 27, 2014
August 1, 2014
11 months
October 31, 2013
August 26, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
completion of cycle 1(28 days)
Secondary Outcomes (1)
dose-limiting toxicities(DLTs) of paclitaxel liposome injection
completion of cycle 1 (28 days)
Other Outcomes (1)
Pharmacokinetic characters of paclitaxel liposome injection compared with paclitaxel injection
0,during infusion 1.5h, 3h, after infusion 15min, 30min, 1h,2h,4h,8h,12h,24h,36h,48h,72 h
Study Arms (6)
Dose level A
EXPERIMENTALPaclitaxel liposome injection 135mg/m2 on day 1, First cycle 28 days and subsequent cycles each 21 days
Dose level B
EXPERIMENTALPaclitaxel liposome injection 175mg/m2 on day 1, First cycle 28 days and subsequent cycles each 21 days
Dose level C
EXPERIMENTALPaclitaxel liposome injection 210mg/m2 on day 1, First cycle 28 days and subsequent cycles each 21 days
Dose level D
EXPERIMENTALPaclitaxel liposome injection 250mg/m2 on day 1, First cycle 28 days and subsequent cycles each 21 days
Dose level E
EXPERIMENTALPaclitaxel liposome injection 300mg/m2 on day 1, First cycle 28 days and subsequent cycles each 21 days
Comparator
ACTIVE COMPARATORPaclitaxel injection 175mg/m2 on day 1, each 21 days
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100032, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
No.52 Fucheng Road, Haidian District,Beijing,
Beijing, Beijing Municipality, 100142, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2013
First Posted
November 25, 2013
Study Start
August 1, 2014
Primary Completion
July 1, 2015
Last Updated
August 27, 2014
Record last verified: 2014-08