Study to compare TAS-102 versus TOPOTECAN OR AMRUBICIN treatmentin patients requiring treatment for Small Cell Lung Cancer.
- Conditions
- Small Cell Lung Cancer that is refractory or sensitive to first-line platinum-based chemotherapy.MedDRA version: 14.1Level: LLTClassification code 10041067Term: Small cell lung cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-004793-26-IT
- Lead Sponsor
- TAIHO PHARMA USA, INC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
1. Has provided written informed consent. 2. Is =18 years of age for patients enrolled in Europe. 3. Has definitive histologically or cytologically confirmed SCLC (limited or extensive disease). 4. Has progressed or had recurrence within 30 days prior to randomization. This progression or recurrence has to be based on imaging after first-line platinum-based chemotherapy. 5. Has at least one measurable lesion, as defined by RECIST criteria, version 1.1 (see Section 9.2 of Protocol). 6. Has ECOG performance status of 0, 1 or 2 in the Baseline period and at the time of randomization. 7. Is able to take medications orally (ie, no feeding tube). 8. Has adequate organ function as defined by the following laboratory values obtained within 5 days prior to randomization: a. Hemoglobin value of =9.0 g/dL. b. WBC count of =3000/mm3 (ie, =3.0 × 109/L by International Units [IU]). c. Platelet count =100,000/mm3 (IU: =100 × 109/L). d. Total serum bilirubin of =1.5 mg/dL (except for Grade 1 hyperbilirubinemia due solely to a medical diagnosis of Gilbert's syndrome). e. Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) =3.0 × upper limit of normal (ULN); if liver function abnormalities are due to underlying liver metastasis, AST and ALT =5 × ULN. f. Serum creatinine of =1.5 mg/dL. g. Creatinine clearance of =20 mL/min (determined according to institutional standard of care). 9. Women of childbearing potential must have a negative pregnancy test (urine or serum) within 7 days prior to randomization. Male and female patients who have the potential to reproduce must agree to use a highly effective method of birth control (ie, pregnancy rate of less than 1% per year) during the study and for 6 months after the discontinuation of study medication. Contraceptive methods that result in a low failure rate when used consistently and correctly include methods such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence, or a female partner who is not of childbearing potential or a male partner who has had a vasectomy. 10. Is willing and able to comply with scheduled visits and study procedures.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
1. Has cerebral metastases unless all of the following apply:a. Cerebral metastases have been treated and controlled, eg, via surgery and/or radiotherapy; b. Cerebral metastases have been stable for at least 2 months postintervention; and c. Patient is not receiving corticosteroids as part of treatment for cerebral metastases. 2. Has a serious illness or serious medical condition(s) including, but not limited to the following: a. Other concurrently active malignancies excluding malignancies that are in remission for more than 5 years or carcinoma-in-situ deemed cured by adequate treatment. b. Active systemic infection (ie, body temperature =38°C due to infection). c. Ascites, pleural effusion or pericardial fluid requiring more than one drainage in last 4 weeks. d. Intestinal obstruction, pulmonary fibrosis, interstitial pneumonitis, renal failure, liver failure, or cerebrovascular disorder.e. Uncontrolled diabetes. f. Myocardial infarction within the last 12 months, severe/unstable angina, symptomatic congestive heart failure New York Heart Association (NYHA) class III or IV). g. Gastrointestinal hemorrhage. h. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or hepatitis B or C. i. Patients with autoimmune disorders or history of organ transplantation who require immunosuppressive therapy. j. Psychiatric disease that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results. 3. Has had treatment with any of the following within the specified time frame prior to study drug administration: a. Major surgery within prior 4 weeks (the surgical incision should be fully healed prior to study drug administration). b. Any anticancer therapy within prior 3 weeks. c. Extended field radiation within prior 4 weeks or limited field radiation within prior 2 weeks. d. Any investigational agent received within prior 4 weeks. 4. Has received TAS-102. 5. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies (excluding anemia, alopecia, skin pigmentation, and platinum-induced neurotoxicity). 6. Is a pregnant or lactating female. 7. Is inappropriate for entry into this study in the judgment of the Investigator.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method