Non-small Cell Lung CancerPhase 2NCT00885963
A Study of Oral Sapacitabine in Patients With Previously Treated Non-Small Cell Lung Cancer
A Phase 2 study testing sapacitabine in people with Non-small Cell Lung Cancer, run by Cyclacel Pharmaceuticals, Inc. at 2 sites in United States.
Trial summary
A phase II study to evaluate the safety and efficacy of oral sapacitabine in previously treated advanced 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?
- sapacitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Dec 2008to 23 Dec 2013
- 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
- Histologically or cytologically confirmed recurrent NSCLC
- Age of 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Measurable disease according to RECIST
- Had only 1 prior chemotherapy regimen for metastatic or recurrent disease; patients who have received more than one prior chemotherapy regimens may participate in Part A of the study only.
- Adequate bone marrow function
Show all 13Show fewer
- Adequate renal function
- Adequate liver function
- 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
- Patient must be able to swallow capsules
- Agree to practice effective contraception during the entire study period and for one month after being discontinued from the study unless documentation of infertility exists. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- Ability to understand and willingness to sign the informed consent form
Who cannot join
- NSCLC histology contains a component of small cell lung cancer
- Previously untreated CNS metastasis or progressive CNS metastasis documented by MRI scan performed at 4 weeks or longer after the last treatment for CNS metastasis
- Currently receiving radiotherapy, biological therapy, or any other investigational agents
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Cancer other than NSCLC that has been treated with chemotherapy or biological therapy in the past 5 years with the exception of adequately treated in situ cervical cancer, and basal or squamous cell skin cancer; patients who received only hormonal therapy in the neoadjuvant or adjuvant setting in the past 5 years may participate in this study
- Pregnant or lactating women
- Known to be HIV-positive
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rush University Medical Center
Chicago, Illinois, 60612
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
About this study
Official title: A Phase II Study of Oral Sapacitabine in Patients With Previously Treated Non-Small Cell Lung Cancer
A phase II study to evaluate the safety and efficacy of oral sapacitabine in previously treated advanced non-small cell lung cancer (NSCLC).
Read the detailed description
This is an open label, single arm, phase II study to evaluate the safety and efficacy of oral sapacitabine administered twice daily for 5 consecutive days every week for 2 weeks followed by 7-day rest in patients who have had one prior chemotherapy regimen for advanced Non-Small Cell Lung Cancer (NSCLC).
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- sapacitabine
- 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.
sapacitabineDrug
Also called CYC682
twice daily by mouth for 7 days or once daily by mouth for 5 days/week x 2 weeks every 21 days
| Study group | Role | What they receive |
|---|---|---|
| sapacitabine | Experimental | Part A (lead-in phase): Two dosing schedules, i.e., once daily (q.d.) or twice daily (b.i.d.) x 5 days/week x 2 weeks every 3 weeks will be evaluated.
Part B (Phase 2): Receive the recommended phase 2 dose of once daily or twice daily dosing schedule derived from Part A. Receives: Drug: sapacitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of response and stable disease
complete response or partial response and stable disease
Measured: after cycle 2, 4, 7 and every 3 cycles thereafter
Secondary outcomes (4)
progression-free survival
Time until disease progression
Measured: 1.5 years
duration of response
Observed response time
Measured: 1.5 years
duration of stable disease
Observed time of the disease state within -30% and +10% of the baseline
Measured: 1.5 years
overall survival
Median survival time of the overall patient population in the study
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2009 (estimated)
- Study start1 Dec 2008
- Primary completion13 Aug 2013
- Study completion23 Dec 2013
Why it stopped: Limitation in financial resources.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cyclacel Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philip Bonomi, M.D., Study chair, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00885963
- Sponsor's protocol ID
- CYC682-08
- Status last verified
- Dec 2021
- First submitted
- 31 Mar 2009
- Last updated
- 22 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
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 II Study of Oral Sapacitabine in Patients With Previously Treated Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00885963
- Acronym / sponsor ID
- CYC682-08
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Limitation in financial resources.
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Cyclacel Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2008 (actual)
- Primary completion
- 13 Aug 2013 (actual)
- Study completion
- 23 Dec 2013 (actual)
- First posted
- 22 Apr 2009 (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 II study to evaluate the safety and efficacy of oral sapacitabine in previously treated advanced non-small cell lung cancer (NSCLC).
Detailed description
This is an open label, single arm, phase II study to evaluate the safety and efficacy of oral sapacitabine administered twice daily for 5 consecutive days every week for 2 weeks followed by 7-day rest in patients who have had one prior chemotherapy regimen for advanced Non-Small Cell Lung Cancer (NSCLC).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sapacitabine | Experimental | Drug: sapacitabinePart A (lead-in phase): Two dosing schedules, i.e., once daily (q.d.) or twice daily (b.i.d.) x 5 days/week x 2 weeks every 3 weeks will be evaluated. Part B (Phase 2): Receive the recommended phase 2 dose of once daily or twice daily dosing schedule derived from Part A. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically or cytologically confirmed recurrent NSCLC
- Age of 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Measurable disease according to RECIST
- Had only 1 prior chemotherapy regimen for metastatic or recurrent disease; patients who have received more than one prior chemotherapy regimens may participate in Part A of the study only.
Key exclusion criteria (7 listed)
- NSCLC histology contains a component of small cell lung cancer
- Previously untreated CNS metastasis or progressive CNS metastasis documented by MRI scan performed at 4 weeks or longer after the last treatment for CNS metastasis
- Currently receiving radiotherapy, biological therapy, or any other investigational agents
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Cancer other than NSCLC that has been treated with chemotherapy or biological therapy in the past 5 years with the exception of adequately treated in situ cervical cancer, and basal or squamous cell skin cancer; patients who received only hormonal therapy in the neoadjuvant or adjuvant setting in the past 5 years may participate in this study
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 |
|---|---|---|
| sapacitabineAlso: CYC682twice daily by mouth for 7 days or once daily by mouth for 5 days/week x 2 weeks every 21 days | Drug | sapacitabine |
Primary outcome
the rate of response and stable disease
Time frame: after cycle 2, 4, 7 and every 3 cycles thereafter
complete response or partial response and stable disease
4 secondary outcomes
progression-free survival
Time frame: 1.5 years
duration of response
Time frame: 1.5 years
duration of stable disease
Time frame: 1.5 years
overall survival
Time frame: 1.5 years
Results and safety
The study was stopped early (reason given: Limitation in financial resources.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2021.
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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.
Philip Bonomi, M.D. study chair
Rush University Medical Center
2 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 sapacitabine in people with Non-small Cell Lung Cancer, run by Cyclacel Pharmaceuticals, Inc. at 2 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 13 inclusion and 7 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 2 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. 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 (reason given: Limitation in financial resources.). 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?
the rate of response and stable disease (time frame: after cycle 2, 4, 7 and every 3 cycles thereafter). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.