Clinical trial NCT00372073: Efficacy Study of Oral Seliciclib to Treat Non-Small Cell Lung Cancer
Official title: A Phase IIb Randomized Study of Oral Seliciclib in Patients With Previously Treated Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Cyclacel Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2006-09-06
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Progression-free survival
timeFrame: over the course of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Cancer Center
state: Arizona
city: Fountain Valley
country: United States
facility: Pacific Coast Hematology Oncology Group
state: California
city: New Port Richey
country: United States
facility: Pasco Hernando Oncology
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
city: Baltimore
country: United States
facility: University of Maryland, Greenebaun Cancer Center
state: Maryland
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Omaha
country: United States
facility: Nebraska Medical Center
state: Nebraska
city: Las Vegas
country: United States
facility: Nevada Cancer Research Foundation
state: Nevada
city: Reno
country: United States
facility: VA Sierra Nevada Health Care System
state: Nevada
city: Albuquerque
country: United States
facility: New Mexico Oncology Hematology Consultants
state: New Mexico
city: New York
country: United States
facility: Columbia Presbyterian Medical Center
state: New York
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburg Cancer Institute
state: Pennsylvania
city: Collierville
country: United States
facility: The Family Cancer Center
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Austin
country: United States
facility: Southwest Regional Cancer Center
state: Texas
city: Dallas
country: United States
facility: Center for Oncology Research and Treatment
state: Texas
city: Tyler
country: United States
facility: East Texas Medical Center
state: Texas
city: Danville
country: United States
facility: Danville Hematology Oncology
state: Virginia
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Chandra Belani, M.D.
role: STUDY_CHAIR
References:
citation: Malumbres M, Barbacid M. Cell cycle, CDKs and cancer: a changing paradigm. Nat Rev Cancer. 2009 Mar;9(3):153-66. doi: 10.1038/nrc2602.