Status:
COMPLETED
A Phase II Study to Evaluate the Efficacy and Safety of TLC388 in Advanced/Metastatic RCC Patients
Lead Sponsor:
Taiwan Liposome Company
Conditions:
Advanced/Metastasis Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
INVESTIGATIONAL PRODUCT: TLC388 (Lipotecan\*) \*Lipotecan is a drug product of TLC388 HCl. PHASE OF DEVELOPMENT: Phase II No. OF PATIENTS: Approximately 40 (Stage I: 15 evaluable patients, Stage ...
Detailed Description
A Phase II, open-label, single-arm, multi-center study to evaluate TLC388 monotherapy in patients with locally advanced and/or metastatic RCC. The study consisted of a Screening/Baseline Period, a Tre...
Eligibility Criteria
Inclusion
- 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. 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. But for the patient with failure of ≥ 2 prior target therapies, ECOG should be ≤ 1.
- 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 \<Grade 2 as 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 correction
- 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
Exclusion
Key Trial Info
Start Date :
November 30 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 21 2017
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01831973
Start Date
November 30 2012
End Date
February 21 2017
Last Update
June 26 2018
Active Locations (5)
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1
Chang Gung Memorial Hospital. Kaohsiung Branch
Kaohsiung City, Taiwan, 833
2
China Medical University Hospital
Taichung, Taiwan, 404
3
Taichung Veterans General Hospital
Taichung, Taiwan, 407
4
National Taiwan University Hospital
Taipei, Taiwan, 10002