Dose Escalation and Pharmacokinetic Study of Paclitaxel Liposome Injection in Treating Patients With Advanced Solid Tumor After Failure From Conventional Treatments

Solid Tumors Clinical Trial

Official title:

Dose Escalation and Pharmacokinetic Study of Paclitaxel Liposome Injection in Treating Patients With Advanced Solid Tumor After Failure From Conventional Treatments

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01994031
• Other study ID #: NJLYSK-LPS-2013-01
• Status: Recruiting
• Phase: Phase 4
• First received: October 31, 2013
• Last updated: August 26, 2014
• Start date: August 2014

Study information

• Verified date: August 2014
• Source: Nanjing Luye Sike Pharmaceutical Co.,Ltd.
• Contact: Jifang Gong, MD
• Phone: 008601088196561
• Email: goodjf[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Solid Tumors

Intervention

Drug:
• Paclitaxel liposome injection

• Paclitaxel injection

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	No.52 Fucheng Road, Haidian District,Beijing,	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Luye Sike Pharmaceutical Co.,Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pharmacokinetic characters of paclitaxel liposome injection compared with paclitaxel injection	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),	0,during infusion 1.5h, 3h, after infusion 15min, 30min, 1h,2h,4h,8h,12h,24h,36h,48h,72 h	No
Primary	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)	Yes
Secondary	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)	completion of cycle 1 (28 days)	Yes