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

Luye Pharma Group

Status and phase: Unknown; Phase 4

Conditions: Solid Tumors

Treatments: Drug: Paclitaxel injection; Drug: Paclitaxel liposome injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT01994031

NJLYSK-LPS-2013-01

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

36 participants in 6 patient groups

Dose level A

Experimental group

Description:

Paclitaxel liposome injection 135mg/m2 on day 1, First cycle 28 days and subsequent cycles each 21 days

Treatment:

Drug: Paclitaxel liposome injection

Dose level B

Experimental group

Description:

Paclitaxel liposome injection 175mg/m2 on day 1, First cycle 28 days and subsequent cycles each 21 days

Treatment:

Drug: Paclitaxel liposome injection

Dose level C

Experimental group

Description:

Paclitaxel liposome injection 210mg/m2 on day 1, First cycle 28 days and subsequent cycles each 21 days

Treatment:

Drug: Paclitaxel liposome injection

Dose level D

Experimental group

Description:

Paclitaxel liposome injection 250mg/m2 on day 1, First cycle 28 days and subsequent cycles each 21 days

Treatment:

Drug: Paclitaxel liposome injection

Dose level E

Experimental group

Description:

Paclitaxel liposome injection 300mg/m2 on day 1, First cycle 28 days and subsequent cycles each 21 days

Treatment:

Drug: Paclitaxel liposome injection

Comparator

Active Comparator group

Description:

Paclitaxel injection 175mg/m2 on day 1, each 21 days

Treatment:

Drug: Paclitaxel injection