Non-small Cell Lung Cancer
Conditions
Brief summary
A phase 2 study to evaluate efficacy of oral seliciclib in treating non-small cell lung cancer (NSCLC).
Detailed description
A randomized Phase II study of an experimental anti-cancer drug called seliciclib with objectives of evaluating safety and efficacy in patients with non-small cell lung cancer.
Interventions
DRUGseliciclib
1200 mg bid x 3 days every 2 weeks
DRUGplacebo
1200 mg bid x 3 days every 2 weeks
Sponsors
Cyclacel Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients with histologically-confirmed recurrent non-small cell lung cancer have had at least two prior systemic treatment regimens * Must have measurable disease according to RECIST * Eastern Cooperative Oncology Group performance status 0-1 * Adequate bone marrow, hepatic and renal function * Ability to swallow capsules * At least 3 weeks from prior systemic treatments including investigational anti-cancer therapy, at least 7 days from prior radiation therapy and have recovered from prior toxicities * At least 3 weeks from major surgery
Exclusion criteria
* Non-small cell cancer histology contains a component of small cell lung cancer * Previously untreated CNS metastasis or progressive CNS metastasis * Prior treatment with a CDK inhibitor * Currently receiving radiotherapy, biological therapy, or any other investigational therapy * Uncontrolled intercurrent illness * Having other cancers that have been treated with chemotherapy or biological therapy in the past 5 years with the exception of adequately treated in situ cervical cancer or basal cell skin cancer * Pregnant or lactating women * Known to be HIV-positive * Active hepatitis B and/or hepatitis C infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | over the course of the study | Time until the disease starts progressing |
Countries
United States
Outcome results
None listed