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Safety and Pharmacokinetic Study

Phase 1b/2a Safety and Pharmacokinetic Study of G1T28 in Patients With Previously Treated Extensive Stage Small Cell Lung Cancer (SCLC) Receiving Topotecan Chemotherapy

Objective

Overview

This is a study to investigate the potential clinical benefit of G1T28 in protecting the bone marrow and preserving the immune system when administered prior to topotecan in patients previously treated for extensive-stage SCLC.

Key Inclusion Criteria

For a patient to be eligible for participation in this study, all of the following criteria must apply.
  • Age ≥ 18 years.
  • Unequivocally confirmed diagnosis of SCLC by histology or cytology, preferably including the presence of neuroendocrine features by immunohistochemistry.
  • Progression during or after prior first- or second-line chemotherapy and eligible to receive topotecan therapy.
  • At least 1 target lesion that is measurable by RECIST, Version 1.1.
  • Absolute neutrophil count ≥ 1.5 × 109 /L.
  • Platelet count ≥ 100 × 109 /L.
  • Creatinine ≤ 1.5 mg/dL and CrCl of ≥ 60 mL/min.
  • Total bilirubin ≤ 1.5 × upper limit of normal (ULN).
  • AST and ALT ≤ 2.5 × ULN; ≤ 5 × ULN in the presence of liver metastases.
  • Serum albumin ≥ 3 g/dL.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  • All clinically significant toxicities from previous anticancer therapy must have resolved to ≤ Grade 1 (except for hemoglobin).
  • Contraception: a) For females: All females of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-hCG) test result at screening and negative serum or urine β-hCG test result 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.
  • Able to understand and sign an informed consent.

Key Exclusion Criteria

A patient will not be eligible for participation in this study if any of the following criteria apply.
  • History of topotecan treatment for SCLC.
  • Presence of brain metastases requiring immediate treatment with radiation therapy or steroids.
  • 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.
  • 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).
  • Known history of stroke or cerebrovascular accident within 6 months prior to enrollment.
  • Serious active infection.
  • Psychiatric illness/social situations that would limit study compliance.
  • Other uncontrolled serious chronic disease or conditions that in the investigator’s opinion could affect compliance or follow-up in the protocol.
  • History of upper gastrointestinal bleeding, ulceration, perforation, or significant gastrointestinal disease within 12 months prior to study enrollment.
  • 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.
  • 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).
  • Receipt of any systemic chemotherapy regimen within 4 weeks prior to enrollment or a noncytotoxic investigational medication within 2 weeks prior to enrollment.
  • Hypersensitivity to any of the components of the formulation of topotecan.
  • Legal incapacity or limited legal capacity.
  • Pregnant or lactating women.
IRB Protocol Number
G1T28-03
Principal Investigator(s)
Melanie Thomas

Clinical Trial Categories

  • Cutaneous & Sarcoma Cancer
Sponsor(s)
G1 Therapeutics, Inc.
How to Participate

Kenneth A. Kuenzli II, RN
864-560-7579
kkuenzli@gibbscc.org

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