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An Open-Label, Single-Arm, Multi-center Phase II Study to Evaluate the Efficacy and Safety of TLC388 in Patients With Advanced/Metastatic Renal Cell Carcinoma

Phase 2
20 Years
Open (Enrolling)
Advanced/Metastasis Renal Cell Carcinoma

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Trial Information

An Open-Label, Single-Arm, Multi-center Phase II Study to Evaluate the Efficacy and Safety of TLC388 in Patients With Advanced/Metastatic Renal Cell Carcinoma

Inclusion Criteria:

- Adult patients defined by age ≥ 18 years

- Histologically confirmed Renal cell carcinoma (RCC)

- Locally advanced or metastatic RCC. Locally advanced RCC: defined as a stage . .
T3/T4 disease, not amenable to curative surgery or radiation therapy, with
involvement of renal vein/vena cava/peripelvic and perirenal fat/adrenal gland, or
invasion beyond Gerota's fascia (Moch et al., 2009). Metastatic RCC: equivalent to
Stage IV RCC, according to American Joint Committee on Cancer (AJCC) staging

- Eastern Collaborative Oncology Group (ECOG) Performance Status of ≤ 2. An ECOG of ≤ 1
for the patient with failure of >= 2 prior target therapies is acceptable

- Documented RCC disease with measurable or non-measurable lesion on imaging by RECIST
v1.1 (Response Evaluation Criteria in Solid Tumors) criteria

- Documented treatment failure of at least 1 prior target therapy (sorafenib, sunitinib
pazopanib or other VEGF TKI, bevacizumab, temsirolimus, everolimus or other mTOR
inhibitor) for advanced or metastatic RCC. If treatment-naïve, . patients with poor
prognosis features according to Memorial Sloan-Kettering Cancer Centre (MSKCC) risk
criteria are acceptable

- Any acute or chronic adverse effects of prior therapy have resolved to determined by CTCAE v4.0 criteria

- Laboratory values at screening:

- Absolute neutrophil count ≥ 1,500 /mm3;

- Platelets ≥ 100,000 /mm3;

- Hemoglobin ≥ 9.0 g/dL;

- Total bilirubin ≤ 1.5 times the upper limit of normal;

- AST (SGOT) ≤ 2.5 times the upper limit of normal;

- ALT (SGPT) ≤ 2.5 times the upper limit of normal;

- Serum creatinine ≤ 2 times the upper limit of normal;

Exclusion Criteria:

- Pregnancy or lactation. Women of childbearing potential must have a negative serum
pregnancy test within 7 days prior to enrolment. Male and female patients of
childbearing potential must agree to use appropriate birth control (barrier methods
with spermicides, oral or parenteral contraceptives and/or intrauterine devices)
during the entire duration of the study, or the patient must be surgically sterile
(with documentation in the patient's medical records)

- Receipt of any chemotherapy for RCC

- Had cardiac angioplasty or stenting event, myocardial infarction or unstable angina
within 3 months of study entry

- Persistent QTc >450 ms for males, or >470 ms for females, according to Fridericia's

- Patients with Grade 3 or greater hyponatremia at screening

- History of Class III or IV congestive heart failure according to New York Heart
Association (NYHA) classification

- History of another malignancy, except for non-basal-cell carcinoma of skin or
carcinoma-in-situ of the uterine cervix, and not disease free ≥5 years

- History or presence of central nervous system (CNS) metastasis or leptomeningeal
tumors as documented by CT or MRI scan, analysis of cerebrospinal fluid or
neurological exam

- History of human immunodeficiency virus infection

- Presence of active, uncontrolled infection

- Radiotherapy received within 4 weeks prior to baseline

- Use of any investigational agents within 4 weeks of baseline

- Major surgery within 4 weeks prior to baseline

- Receipt of radiotherapy to >25 % of bone marrow

- Concomitant treatment with, or anticipated use of, pharmaceutical or herbal agents
which are potent inhibitors or inducers of cytochrome P450 enzymes (Appendix D1),
unless approved by the Sponsor

- Uncontrolled intercurrent illness that would jeopardize patient safety, or interfere
with the objectives of the protocol, or limit patient compliance with study
requirements, as determined by the Investigator

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluate non-progression disease (non-PD) rate at the end of cycle 6

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Min-Hsiung Kao, MS

Investigator Role:

Study Director

Investigator Affiliation:

Taiwan Liposome Company


Taiwan: Department of Health

Study ID:




Start Date:

October 2012

Completion Date:

Related Keywords:

  • Advanced/Metastasis Renal Cell Carcinoma
  • Carcinoma
  • Carcinoma, Renal Cell
  • Neoplasm Metastasis