Efficacy Study of Oral Seliciclib to Treat Non-Small Cell Lung Cancer
A Phase IIb Randomized Study of Oral Seliciclib in Patients With Previously Treated Non-Small Cell Lung Cancer
1 other identifier
interventional
187
1 country
20
Brief Summary
A phase 2 study to evaluate efficacy of oral seliciclib in treating non-small cell lung cancer (NSCLC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 nonsmall-cell-lung-cancer
Started Aug 2006
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 9, 2006
CompletedFirst Submitted
Initial submission to the registry
September 3, 2006
CompletedFirst Posted
Study publicly available on registry
September 6, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 3, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 7, 2009
CompletedDecember 22, 2021
December 1, 2021
2.6 years
September 3, 2006
December 7, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free survival
Time until the disease starts progressing
over the course of the study
Study Arms (2)
Arm 1 with seliciclib
ACTIVE COMPARATOROral 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.
Arm 2 with placebo control
PLACEBO COMPARATORRandomized to placebo after run-in period.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Arizona Cancer Center
Tucson, Arizona, 85724, United States
Pacific Coast Hematology Oncology Group
Fountain Valley, California, 92708, United States
Pasco Hernando Oncology
New Port Richey, Florida, 34652, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
The University of Chicago
Chicago, Illinois, 60637, United States
University of Maryland, Greenebaun Cancer Center
Baltimore, Maryland, 21201, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106, United States
VA Sierra Nevada Health Care System
Reno, Nevada, 89502, United States
New Mexico Oncology Hematology Consultants
Albuquerque, New Mexico, 87109, United States
Columbia Presbyterian Medical Center
New York, New York, 10032, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
University of Pittsburg Cancer Institute
Pittsburgh, Pennsylvania, 15232, United States
The Family Cancer Center
Collierville, Tennessee, 38017, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Southwest Regional Cancer Center
Austin, Texas, 78705, United States
Center for Oncology Research and Treatment
Dallas, Texas, 75230, United States
East Texas Medical Center
Tyler, Texas, 75701, United States
Danville Hematology Oncology
Danville, Virginia, 24541, United States
Related Publications (1)
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.
PMID: 19238148DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Chandra Belani, M.D.
Milton S. Hershey Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 3, 2006
First Posted
September 6, 2006
Study Start
August 9, 2006
Primary Completion
March 3, 2009
Study Completion
April 7, 2009
Last Updated
December 22, 2021
Record last verified: 2021-12