Non-small Cell Lung Cancer Clinical Trial
Official title:
A Phase IIb Randomized Study of Oral Seliciclib in Patients With Previously Treated Non-Small Cell Lung Cancer
| Verified date | December 2021 |
| Source | Cyclacel Pharmaceuticals, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
A phase 2 study to evaluate efficacy of oral seliciclib in treating non-small cell lung cancer (NSCLC).
| Status | Terminated |
| Enrollment | 187 |
| Est. completion date | April 7, 2009 |
| Est. primary completion date | March 3, 2009 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | New Mexico Oncology Hematology Consultants | Albuquerque | New Mexico |
| United States | Southwest Regional Cancer Center | Austin | Texas |
| United States | University of Maryland, Greenebaun Cancer Center | Baltimore | Maryland |
| United States | Dana Farber Cancer Institute | Boston | Massachusetts |
| United States | Rush University Medical Center | Chicago | Illinois |
| United States | The University of Chicago | Chicago | Illinois |
| United States | The Family Cancer Center | Collierville | Tennessee |
| United States | Center for Oncology Research and Treatment | Dallas | Texas |
| United States | Danville Hematology Oncology | Danville | Virginia |
| United States | Pacific Coast Hematology Oncology Group | Fountain Valley | California |
| United States | Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania |
| United States | Nevada Cancer Research Foundation | Las Vegas | Nevada |
| United States | Vanderbilt University Medical Center | Nashville | Tennessee |
| United States | Pasco Hernando Oncology | New Port Richey | Florida |
| United States | Columbia Presbyterian Medical Center | New York | New York |
| United States | Nebraska Medical Center | Omaha | Nebraska |
| United States | University of Pittsburg Cancer Institute | Pittsburgh | Pennsylvania |
| United States | VA Sierra Nevada Health Care System | Reno | Nevada |
| United States | Arizona Cancer Center | Tucson | Arizona |
| United States | East Texas Medical Center | Tyler | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Cyclacel Pharmaceuticals, Inc. |
United States,
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|---|---|---|---|---|
| Primary | Progression-free survival | Time until the disease starts progressing | over the course of the study |
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