Stage IIIB/IV Non-small cell lung cancer
Conditions
Interventions
Product Name: seliciclib
Product Code: CYC202
Pharmaceutical Form: Capsule*
INN or Proposed INN: seliciclib
Current Sponsor code: CYC202
Other descriptive name: R-roscovitine
Concentration unit: mg mi
Sponsors
Cyclacel Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eligible patients completing the full treatment period with CYC202 in a CYC202 clinical trial with a disease status of at least stable disease at the end of the trial. At least one measurable lesion as defined in the original trial protocol. WHO performance status of 0-2. Life expectancy > 3 months. Adequate clinical pathology values (Blood pathology values as within the inclusion criteria of the first CYC202 trial; Creatinine clearance >= 60ml/min; Bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range ;Inclusion criteria: Eligible patients completing the full treatment period with CYC202 in a CYC202 clinical trial with a disease status of at least stable disease at the end of the trial. At least one measurable lesion as defined in the original trial protocol. WHO performance status of 0-2. Life expectancy > 3 months. Adequate clinical pathology values (Blood pathology values as within the inclusion criteria of the first CYC202 trial; Creatinine clearance >= 60ml/min; Bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients who, in the opinion of the Investigator, showed poor treatment compliance in the original CYC202 clinical trial; or poor compliance of the study centre during evaluation visits. Patients who withdrew consent during the original CYC202 clinical trial. Any concomitant condition that could compromise the objectives of this study and the patient's compliance. Patients who cannot swallow or patients with chronic gastrointestinal disease or conditions that may hamper compliance and/or absorption of the tested product. Pregnant or lactating woman. Major thoracic and/or abdominal surgery in the preceding 3 weeks. Known currently active HIV, HBV or HCV infection. ;Exclusion criteria: Patients who, in the opinion of the Investigator, showed poor treatment compliance in the original CYC202 clinical trial; or poor compliance of the study centre during evaluation visits. Patients who withdrew consent during the original CYC202 clinical trial. Any concomitant condition that could compromise the objectives of this study and the patient's compliance. Patients who cannot swallow or patients with chronic gastrointestinal disease or conditions that may hamper compliance and/or absorption of the tested product. Pregnant or lactating woman. Major thoracic and/or abdominal surgery in the preceding 3 weeks. Known currently active HIV, HBV or HCV infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To collect long-term safety and tolerability data from patients receiving CYC202.;Secondary Objective: To evaluate tumour response data following prolonged CYC202 treatment.;Primary end point(s): Determination of safety and tolerability: Assessment of Adverse Events; Baseline and serial examination of physical status, vital signs, blood haematology, blood chemistry, urine;Main Objective: To collect long-term safety and tolerability data from patients receiving CYC202.;Secondary Objective: To evaluate tumour response data following prolonged CYC202 treatment.;Primary end point(s): Determination of safety and tolerability: Assessment of Adverse Events; Baseline and serial examination of physical status, vital signs, blood haematology, blood chemistry, urine | — |
Countries
United Kingdom
Contacts
Public Contact; ;
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Outcome results
None listed