A study to assess the safety and tolerability of combining G1T28 with etoposide and carboplatin therapy and to evaluate the effect of G1T28 on blood cell production affected by chemotherapy.
- Conditions
- Extensive-Stage Small Cell Lung Cancer (SCLC)MedDRA version: 19.0 Level: PT Classification code 10041068 Term: Small cell lung cancer extensive stage System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-001583-11-HU
- Lead Sponsor
- G1 Therapeutics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 110
1. Age = 18 years
2. Unequivocally confirmed diagnosis of SCLC by histology or cytology, preferably including the presence of neuroendocrine features by immunohistochemistry
3. Extensive-stage disease
4. At least 1 target lesion that is unirradiated and measurable by RECIST, Version 1.1 (Eisenhauer 2009)
5. Hemoglobin = 9.0 g/dL
6. Absolute neutrophil count = 1.5 × 109/L
7. Platelet count = 100 × 109/L
8. Creatinine = 1.5 mg/dL OR glomerular filtration rate (GFR) of = 60 mL/min (by Cockcroft-Gault formula [Cockcroft and Gault 1976]); creatinine clearance calculated from an isotopic method or a 24-hour urine collection may be used instead of an estimated GFR by the Cockcroft-Gault formula
9. Total bilirubin = 1.5 × upper limit of normal (ULN)
10. AST and ALT = 2.5 × ULN; = 5 × ULN in the presence of liver metastases
11. Serum albumin = 3 g/dL
12. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
13. Predicted life expectancy of = 3 months
14. Contraception:
a. For females: All females of childbearing potential must have a negative serum beta human chorionic gonadotropin (ß-hCG) test result at screening and at baseline. Females must be either postmenopausal, surgically sterile, or using an acceptable method of contraception. Acceptable surgical sterilization techniques are hysterectomy, bilateral tubal ligation with surgery at least 6 months prior to dosing, and bilateral oophorectomy, with surgery at least 2 months prior to dosing. Acceptable methods of contraception are an intrauterine device, contraceptive implant, oral contraceptive (stable dose of the same hormonal contraceptive product for at least 3 months prior to dosing), a vasectomized partner, and a barrier method (condom or diaphragm) during the study and for 3 months after discontinuation of treatment
b. For males: Patients with female partner of childbearing potential must agree to use a highly effective form of birth control, which entails the use of oral, injected, or implanted hormonal methods of contraception or an intrauterine device/system by the female partner, in combination with a barrier method (eg, condom, diaphragm, cervical cap) during the study and for 3 months after discontinuation of treatment, and will also refrain from sperm donation for 3 months following completion of the study
15. Able to understand and sign an informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70
1. Prior chemotherapy for limited or extensive-stage SCLC
2. Presence of symptomatic brain metastases requiring immediate treatment with radiation therapy or steroids.
3. History of other malignancies, except for the following: (1) adequately treated basal or squamous cell carcinoma of the skin; (2) curatively treated a) in situ carcinoma of the uterine cervix, b) prostate cancer, or c) superficial bladder cancer; or (3) other curatively treated solid tumor with no evidence of disease for = 3 years
4. Uncontrolled ischemic heart disease or uncontrolled symptomatic congestive heart failure (Class III or IV as defined by the New York Heart Association [NYHA] functional classification system)
5. Known history of stroke or cerebrovascular accident within 6 months prior to enrollment
6. Serious active infection
7. Psychiatric illness/social situations that would limit study compliance
8. Other uncontrolled serious chronic disease or conditions that in the investigator’s opinion could affect compliance or follow-up in the protocol
9. Known human immunodeficiency virus (HIV), known hepatitis B virus (HBV), or known hepatitis C virus (HCV) positive that is symptomatic or requiring active therapy
10. Concurrent radiotherapy to any site or radiotherapy within 2 weeks prior to enrollment or previous radiotherapy to the target lesion sites (the sites that are to be followed for determination of a response)
11. Receipt of any investigational medication within 4 weeks prior to enrollment
12. Hypersensitivity to any of the components of the formulation of etoposide or etoposide phosphate
13. Hypersensitivity to cisplatin or other platinum-containing compounds, or mannitol
14. Legal incapacity or limited legal capacity
15. Pregnant or lactating women
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