A Phase II Study to Evaluate the Efficacy and Safety of TLC388 in Advanced/Metastatic RCC Patients

NCT01831973 | Completed Phase 2

• 1 other identifier: TLC388.3
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 5

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 II: 25 evaluable patients) STUDY OBJECTIVES: Primary

• To evaluate non-progression disease (non-PD) rate at the end of cycle 6 Secondary
• To evaluate progression free survival (PFS)
• To evaluate overall survival (OS)
• To evaluate the duration of non-PD
• To evaluate objective response rate (ORR; where ORR= CR+PR) and duration
• To evaluate the safety profile of TLC388
• To evaluate change in health-related quality of life (HRQOL) at the end of cycle 6 STUDY DESIGN: This is a Phase II, open-label, single-arm, multi-centre study to evaluate TLC388 monotherapy in patients with locally advanced and/or metastatic renal cell carcinoma (RCC).

Conditions

Advanced/Metastasis Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

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

  Non-progression disease rate after cycle 6

  6 months

Secondary Outcomes (6)

• Progression free survival (PFS)

  3 years

• Overall survival (OS)

  3 years

• Duration of non-PD

  3 years

• Objective response rate (ORR; where ORR= CR+PR) and duration

  3 years

• Safety profile of TLC388

  3 years

Study Arms (1)

Lipotecan, injection for chemotherapy

EXPERIMENTAL

Patients receive TLC388 (50 mg/m2) given as a 30-minute IV infusion, on Days 1, 8, and 15 of a 28-day cycle.

Drug: Lipotecan

Interventions

Lipotecan DRUG

Also known as: TLC388

Lipotecan, injection for chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Taiwan Liposome Company: lead

Study Sites (5)

Chang Gung Memorial Hospital. Kaohsiung Branch

Kaohsiung City, 833, Taiwan

Location

China Medical University Hospital

Taichung, 404, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 407, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Chang Gung Memorial Hospital: LinKou Branch

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Interventions

TLC 388

Study Officials

• Dr. Yvonne Shi

  Taiwan Liposome Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2013
• First Posted: April 15, 2013
• Study Start: November 30, 2012
• Primary Completion: March 19, 2015
• Study Completion: February 21, 2017
• Last Updated: June 26, 2018

Record last verified: 2018-06

Locations

TW (5)