A clinical trial to test the safety and plasma concentration of G1T28 in combination with topotecan in patients with previously treated extensive stage small cell lung cancer
- Conditions
- Extensive-Stage Small Cell Lung CancerMedDRA version: 20.0Level: PTClassification code 10041068Term: Small cell lung cancer extensive stageSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-004611-13-SK
- Lead Sponsor
- G1 Therapeutics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 90
1. Age = 18 years
2. Unequivocally confirmed diagnosis of SCLC by histology or cytology, preferably including the presence of neuroendocrine features by immunohistochemistry
3. Progression during or after prior first- or second-line chemotherapy and eligible to receive topotecan therapy(immunotherapy treatment alone, ie, not administered with chemotherapy, should not be counted as a line of chemotherapy)
4. At least 1 target lesion that is measurable by RECIST, Version 1.1
5. Absolute neutrophil count = 1.5 × 109/L
6. Platelet count = 100 × 109/L
7. Creatinine = 1.5 mg/dL and creatinine clearance (CrCl) of = 60 mL/minute)
8. Total bilirubin = 1.5 × upper limit of normal (ULN)
9. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 × ULN; = 5 × ULN in the
presence of liver metastases
10. Serum albumin = 3 g/dL
11. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
12. All clinically significant toxicities from previous anticancer therapy must have resolved to = Grade 1 (except for hemoglobin)
13. 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 negative serum or urine ß-hCG test result at baseline.
Females must be either postmenopausal, surgically sterile, or using an acceptable method of contraception in combination with a barrier method.
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 to be used in combination with a
barrier method are an intrauterine device, contraceptive implant, oral contraceptive (stable dose of the same hormonal contraceptive product for at least 3 months prior to dosing), or a vasectomized partner. These methods are to be utilized 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
14. 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 55
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 35
1. History of topotecan treatment for SCLC
2. Presence of 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. History of upper gastrointestinal bleeding, ulceration, perforation, or significant gastrointestinal disease within 12 months prior to study enrollment
10. Known human immunodeficiency virus (HIV) positive; known hepatitis B virus (HBV) positive; or known hepatitis C virus (HCV) positive that is symptomatic or requiring active therapy
11. 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)
12. Receipt of any systemic chemotherapy regimen within 4 weeks prior to enrollment or a noncytotoxic investigational medication within 2 weeks prior to enrollment
13. Receipt of any low-dose systemic chemotherapeutic agent given for a nononcologic purpose within 4 weeks prior to enrollment (eg, low-dose methotrexate for rheumatoid arthritis)
14. Hypersensitivity to any of the components of the formulation of topotecan
15. Legal incapacity or limited legal capacity
16. 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