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

• Status: Terminated
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized Phase II study of an experimental anti-cancer drug called seliciclib. The main objective of this study is to learn if, and how long, seliciclib can keep the non-small cell lung cancer in check.

An experimental drug is a drug which has not been approved by the U.S. Food and Drug Administration (FDA) or other regulatory agencies for marketing and is still under study to determine how safe it is, what its side-effects are, and whether or not it is effective in the treatment of non-small cell lung cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cyclacel Pharmaceuticals, Inc.
• Treatments: Roscovitine

Criteria

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