Breast NeoplasmsPhase 2NCT00732810
SCH 727965 in Patients With Advanced Breast and Lung Cancers (Study P04716)
A Phase 2 study testing SCH 727965, Capecitabine and Erlotinib in people with Breast Neoplasms and Carcinoma, Non-Small-Cell Lung, run by Merck Sharp & Dohme LLC.
Trial summary
To determine the activity of SCH 727965 in participants with breast cancer and in participants with nonsmall-cell lung cancer (NSCLC) compared to standard treatment. The standard treatment used is capecitabine for breast cancer and erlotinib for NSCLC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasms, Carcinoma, Non-Small-Cell Lung
- What is being tested?
- SCH 727965, Capecitabine and Erlotinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- No sites listed yet
- Study dates
- Jul 2008to Jun 2011
- 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
- Age >=18 years, either sex, any race.
- Histologically or cytologically confirmed breast cancer or NSCLC; and radiographic or clinically advanced disease.
- BREAST CANCER:
- participant must have previously received both a taxane and an anthracycline (unless anthracycline therapy is contraindicated) in the adjuvant and/or metastatic setting,
- participant with HER2-positive disease must have progressed after trastuzumab and concomitant or subsequent lapatinib,
- participant must have received at least one, but no more than two prior regimens for recurrent or metastatic disease (endocrine and biologic therapies do not count as chemotherapeutic regimens).
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- NSCLC: at least one, but no more than two prior chemotherapeutic regimens for advanced disease.
- Measurable disease by the RECIST.
- Eastern Cooperative Oncology Group performance status of 0, 1, or 2.
- Adequate hematologic, renal, and hepatic organ function and laboratory parameters.
- Ability to swallow tablets.
Who cannot join
- Known brain metastases. For NSCLC only, a participant with central nervous system metastasis is eligible provided the participant has received definitive local therapy (ie, radiation therapy or surgery), has stopped receiving treatment with corticosteroids, and is without symptoms for at least 4 weeks before randomization.
- History of previous radiation therapy to >25% of total bone marrow.
- Known HIV infection.
- Known active hepatitis B or hepatitis C.
- Previous treatment with SCH 727965 or other cyclin-dependent-kinase inhibitors.
- BREAST CANCER:
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- known dihydropyrimidine dehydrogenase deficiency,
- previous treatment with capecitabine.
- NSCLC: previous treatment with erlotinib.
About this study
Official title: A Randomized Phase 2 Study of SCH 727965 in Subjects With Advanced Breast and Non Small Cell Lung (NSCLC) Cancers
To determine the activity of SCH 727965 in participants with breast cancer and in participants with nonsmall-cell lung cancer (NSCLC) compared to standard treatment. The standard treatment used is capecitabine for breast cancer and erlotinib for NSCLC. The study will also determine the activity of SCH 727965 treatment in participants who experience cancer progression after standard treatment.
- Conditions
- Breast Neoplasms, Carcinoma, Non-Small-Cell Lung
- Being tested
- SCH 727965, Capecitabine, Erlotinib
- Medical subject headings
- Breast Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCH 727965Drug
SCH 727965 50 mg/m^2 IV on Day 1 of each 21 day cycle until disease progression.
CapecitabineDrug
Also called Xeloda
Capecitabine 1250 mg/m^2 orally twice daily from Day 1 to Day 14 of each 21 day cycle until disease progression.
ErlotinibDrug
Also called Tarceva
Erlotinib 150 mg orally once daily until disease progression.
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer randomized to SCH 727965 | Experimental | Not described Receives: Drug: SCH 727965 |
| Breast cancer randomized to capecitabine | Active comparator | Not described Receives: Drug: Capecitabine |
| SCH 727965 in breast cancer after progression on capecitabine | Experimental | Not described Receives: Drug: SCH 727965 |
| NSCLC randomized to SCH 727965 | Experimental | Note: Enrollment of participants with NSCLC was completed per protocol as of 26 JAN 2010 Receives: Drug: SCH 727965 |
| NSCLC randomized to erlotinib | Active comparator | Note: Enrollment of participants with NSCLC was completed per protocol as of 26 JAN 2010 Receives: Drug: Erlotinib |
| SCH 727965 in NSCLC after progression on erlotinib | Experimental | Note: Crossover to SCH 727965 after progression on erlotinib was completed per protocol as of 26 JAN 2010 Receives: Drug: SCH 727965 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to disease progression.
Date of randomization to date of tumor progression.
Measured: Every 6 weeks for 30 weeks, and then every 9 weeks. Assessments continue until disease progression.
Overall response rate in participants treated with SCH 727965 after disease progression on the comparator drug.
Percentage of participants with tumor responses (partial responses + complete responses).
Measured: Every 6 weeks for 30 weeks, and then every 9 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2008 (estimated)
- Study startJul 2008
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00732810
- Sponsor's protocol ID
- P04716
- Status last verified
- Aug 2015
- First submitted
- 8 Aug 2008
- Last updated
- 5 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Mita MM, Joy AA, Mita A, Sankhala K, Jou YM, Zhang D, Statkevich P, Zhu Y, Yao SL, Small K, Bannerji R, Shapiro CL. Randomized phase II trial of the cyclin-dependent kinase inhibitor dinaciclib (MK-7965) versus capecitabine in patients with advanced breast cancer. Clin Breast Cancer. 2014 Jun;14(3):169-76. doi: 10.1016/j.clbc.2013.10.016. Epub 2013 Oct 26.
PubMed 24393852Stephenson JJ, Nemunaitis J, Joy AA, Martin JC, Jou YM, Zhang D, Statkevich P, Yao SL, Zhu Y, Zhou H, Small K, Bannerji R, Edelman MJ. Randomized phase 2 study of the cyclin-dependent kinase inhibitor dinaciclib (MK-7965) versus erlotinib in patients with non-small cell lung cancer. Lung Cancer. 2014 Feb;83(2):219-23. doi: 10.1016/j.lungcan.2013.11.020. Epub 2013 Dec 2.
PubMed 24388167
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase 2 Study of SCH 727965 in Subjects With Advanced Breast and Non Small Cell Lung (NSCLC) Cancers
- ClinicalTrials.gov ID
- NCT00732810
- Acronym / sponsor ID
- P04716
- Conditions
- Breast Neoplasms, Carcinoma, Non-Small-Cell Lung
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 12 Aug 2008 (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.
To determine the activity of SCH 727965 in participants with breast cancer and in participants with nonsmall-cell lung cancer (NSCLC) compared to standard treatment. The standard treatment used is capecitabine for breast cancer and erlotinib for NSCLC. The study will also determine the activity of SCH 727965 treatment in participants who experience cancer progression after standard treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Breast cancer randomized to SCH 727965 | Experimental | Drug: SCH 727965 |
| Breast cancer randomized to capecitabine | Active comparator | Drug: Capecitabine |
| SCH 727965 in breast cancer after progression on capecitabine | Experimental | Drug: SCH 727965 |
| NSCLC randomized to SCH 727965 | Experimental | Drug: SCH 727965Note: Enrollment of participants with NSCLC was completed per protocol as of 26 JAN 2010 |
| NSCLC randomized to erlotinib | Active comparator | Drug: ErlotinibNote: Enrollment of participants with NSCLC was completed per protocol as of 26 JAN 2010 |
| SCH 727965 in NSCLC after progression on erlotinib | Experimental | Drug: SCH 727965Note: Crossover to SCH 727965 after progression on erlotinib was completed per protocol as of 26 JAN 2010 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age >=18 years, either sex, any race.
- Histologically or cytologically confirmed breast cancer or NSCLC; and radiographic or clinically advanced disease.
- BREAST CANCER:
- NSCLC: at least one, but no more than two prior chemotherapeutic regimens for advanced disease.
- Measurable disease by the RECIST.
Key exclusion criteria (9 listed)
- Known brain metastases. For NSCLC only, a participant with central nervous system metastasis is eligible provided the participant has received definitive local therapy (ie, radiation therapy or surgery), has stopped receiving treatment with corticosteroids, and is without symptoms for at least 4 weeks before randomization.
- History of previous radiation therapy to >25% of total bone marrow.
- Known HIV infection.
- Known active hepatitis B or hepatitis C.
- Previous treatment with SCH 727965 or other cyclin-dependent-kinase inhibitors.
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 |
|---|---|---|
| SCH 727965SCH 727965 50 mg/m^2 IV on Day 1 of each 21 day cycle until disease progression. | Drug | Breast cancer randomized to SCH 727965, NSCLC randomized to SCH 727965, SCH 727965 in NSCLC after progression on erlotinib, SCH 727965 in breast cancer after progression on capecitabine |
| CapecitabineAlso: XelodaCapecitabine 1250 mg/m^2 orally twice daily from Day 1 to Day 14 of each 21 day cycle until disease progression. | Drug | Breast cancer randomized to capecitabine |
| ErlotinibAlso: TarcevaErlotinib 150 mg orally once daily until disease progression. | Drug | NSCLC randomized to erlotinib |
Primary outcome
Time to disease progression.
Time frame: Every 6 weeks for 30 weeks, and then every 9 weeks. Assessments continue until disease progression.
Date of randomization to date of tumor progression.
Overall response rate in participants treated with SCH 727965 after disease progression on the comparator drug.
Time frame: Every 6 weeks for 30 weeks, and then every 9 weeks.
Percentage of participants with tumor responses (partial responses + complete responses).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2015.
- Results publication: PubMed 24393852Mita MM, Joy AA, Mita A, Sankhala K, Jou YM, Zhang D, Statkevich P, Zhu Y, Yao SL, Small K, Bannerji R, Shapiro CL. Randomized phase II trial of the cyclin-dependent kinase inhibitor dinaciclib (MK-7965) versus capecitabine in patients with advanced breast cancer. Clin Breast Cancer. 2014 Jun;14(3):169-76. doi: 10.1016/j.clbc.2013.10.016. Epub 2013 Oct 26.
- Results publication: PubMed 24388167Stephenson JJ, Nemunaitis J, Joy AA, Martin JC, Jou YM, Zhang D, Statkevich P, Yao SL, Zhu Y, Zhou H, Small K, Bannerji R, Edelman MJ. Randomized phase 2 study of the cyclin-dependent kinase inhibitor dinaciclib (MK-7965) versus erlotinib in patients with non-small cell lung cancer. Lung Cancer. 2014 Feb;83(2):219-23. doi: 10.1016/j.lungcan.2013.11.020. Epub 2013 Dec 2.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SCH 727965, Capecitabine and Erlotinib in people with Breast Neoplasms and Carcinoma, Non-Small-Cell Lung, run by Merck Sharp & Dohme LLC.
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 11 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: finished, as of the sponsor's last update on 5 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to disease progression. (time frame: Every 6 weeks for 30 weeks, and then every 9 weeks. Assessments continue until disease progression.). The study lists 2 primary outcomes in all. 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 NCT00732810, which also lists 2 linked publications.
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 5 Aug 2015.