Non-small Cell Lung CancerPhase 2NCT00372073
Efficacy Study of Oral Seliciclib to Treat Non-Small Cell Lung Cancer
A Phase 2 study testing seliciclib in people with Non-small Cell Lung Cancer, run by Cyclacel Pharmaceuticals, Inc. at 20 sites in United States.
Trial summary
A phase 2 study to evaluate efficacy of oral seliciclib in treating non-small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- seliciclib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 187 participants
- Where
- 20 sitesUnited States
- Study dates
- 9 Aug 2006to 7 Apr 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Pregnant or lactating women
- Known to be HIV-positive
- Active hepatitis B and/or hepatitis C infection
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
New Mexico Oncology Hematology Consultants
Albuquerque, New Mexico, 87109
Southwest Regional Cancer Center
Austin, Texas, 78705
University of Maryland, Greenebaun Cancer Center
Baltimore, Maryland, 21201
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Rush University Medical Center
Chicago, Illinois, 60612
The University of Chicago
Chicago, Illinois, 60637
The Family Cancer Center
Collierville, Tennessee, 38017
Center for Oncology Research and Treatment
Dallas, Texas, 75230
Danville Hematology Oncology
Danville, Virginia, 24541
Pacific Coast Hematology Oncology Group
Fountain Valley, California, 92708
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Pasco Hernando Oncology
New Port Richey, Florida, 34652
Columbia Presbyterian Medical Center
New York, New York, 10032
Nebraska Medical Center
Omaha, Nebraska, 68198
University of Pittsburg Cancer Institute
Pittsburgh, Pennsylvania, 15232
VA Sierra Nevada Health Care System
Reno, Nevada, 89502
Arizona Cancer Center
Tucson, Arizona, 85724
East Texas Medical Center
Tyler, Texas, 75701
About this study
Official title: A Phase IIb Randomized Study of Oral Seliciclib in Patients With Previously Treated Non-Small Cell Lung Cancer
A phase 2 study to evaluate efficacy of oral seliciclib in treating non-small cell lung cancer (NSCLC).
Read the 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.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- seliciclib, placebo
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
seliciclibDrug
Also called CYC202
1200 mg bid x 3 days every 2 weeks
placeboDrug
1200 mg bid x 3 days every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 with seliciclib | Active comparator | 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. Receives: Drug: seliciclib |
| Arm 2 with placebo control | Placebo comparator | Randomized to placebo after run-in period. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Time until the disease starts progressing
Measured: over the course of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2006 (estimated)
- Study start9 Aug 2006
- Primary completion3 Mar 2009
- Study completion7 Apr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cyclacel Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chandra Belani, M.D., Study chair, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00372073
- Sponsor's protocol ID
- CYC202-06-14 (A1)
- Status last verified
- Dec 2021
- First submitted
- 3 Sep 2006
- Last updated
- 22 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19238148
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIb Randomized Study of Oral Seliciclib in Patients With Previously Treated Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00372073
- Acronym / sponsor ID
- CYC202-06-14 (A1)
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Cyclacel Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Aug 2006 (actual)
- Primary completion
- 3 Mar 2009 (actual)
- Study completion
- 7 Apr 2009 (actual)
- First posted
- 6 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 with seliciclib | Active comparator | Drug: seliciclibOral 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 comparator | Drug: placeboRandomized to placebo after run-in period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| seliciclibAlso: CYC2021200 mg bid x 3 days every 2 weeks | Drug | Arm 1 with seliciclib |
| placebo1200 mg bid x 3 days every 2 weeks | Drug | Arm 2 with placebo control |
Primary outcome
Progression-free survival
Time frame: over the course of the study
Time until the disease starts progressing
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2021.
- Derived from this study: PubMed 19238148Malumbres M, Barbacid M. Cell cycle, CDKs and cancer: a changing paradigm. Nat Rev Cancer. 2009 Mar;9(3):153-66. doi: 10.1038/nrc2602.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chandra Belani, M.D. study chair
Milton S. Hershey Medical Center
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing seliciclib in people with Non-small Cell Lung Cancer, run by Cyclacel Pharmaceuticals, Inc. at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: over the course of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00372073, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2021.