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A phase I study to assess the tolerance and pharmacokinetics of ursolic acid liposomes

A phase I study to assess the tolerance and pharmacokinetics of ursolic acid liposomes

Status
Active, not recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONC-12002385
Enrollment
Unknown
Registered
2012-07-31
Start date
2009-08-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced solid tumors

Interventions

1:a consecutive 14-day intravenous infusion every 21 days

Sponsors

Tianjin Medical University Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Eligible patients were aged 18–75 years, with a cytologically or histologically confirmed advanced solid tumors refractory to standard therapies or for which a standard effective therapy did not exist; Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2; Karnofsky score >=60%; a life expectancy>=3 months; practicing adequate contraception; an adequate haematological function [white blood cell (WBC) count >=4.0*10^9/l; absolute neutrophil count (ANC) >=2.0*10^9/l; platelet count >=100*10^9/l; haemoglobin >=100 g/l]; adequate hepatic and renal function [alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) <=2.5 the upper limit of normal (ULN) or 5*ULN for hepatic cancer/metastatic hepatic cancer; total bilirubin (TBIL) <=1.5*ULN; serum creatinine <=1.5*ULN; creatinine clearance rate<=1.5*ULN; normal UREA]; normal pulmonary function.

Exclusion criteria

Exclusion criteria: 1. be going to be receved other therapy; 2. pregnancy; 3. and so on.

Design outcomes

Primary

MeasureTime frame
safety, the recommended dose (RD) for phase II trial, pharmacokinetics;

Countries

China

Contacts

Public ContactWang Huaqing
huaqingw@163.com+86 13802198822

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 25, 2026