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

Cyclacel Pharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: seliciclib; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00372073

CYC202-06-14 (A1)

Details and patient eligibility

About

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

Full 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.

Enrollment: 187 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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187 participants in 2 patient groups, including a placebo group

Arm 1 with seliciclib

Active Comparator group

Description:

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.

Treatment:

Drug: seliciclib

Arm 2 with placebo control

Placebo Comparator group

Description:

Randomized to placebo after run-in period.

Treatment:

Drug: placebo