Efficacy Study of Oral Seliciclib to Treat Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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A phase 2 study to evaluate efficacy of oral seliciclib in treating non-small cell lung cancer (NSCLC).

Detailed Description
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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.

Official Title
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A Phase IIb Randomized Study of Oral Seliciclib in Patients With Previously Treated Non-Small Cell Lung Cancer

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: seliciclib
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1 with seliciclib<br>Oral seliciclib at 1200mg b.i.d. for 3 consecutive days as an outpatient beginning on day 1 every 2 weeks for 3 cycles as run-in. Patients (randomized) continue on treatment if derived clinical benefit during run-in period. | Drug: seliciclib<br>* 1200 mg bid x 3 days every 2 weeks<br>* Other names: CYC202;|
| Placebo Comparator: Arm 2 with placebo control<br>Randomized to placebo after run-in period. | Drug: placebo<br>* 1200 mg bid x 3 days every 2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | Time until the disease starts progressing | over the course of the study |