SCH 727965 in Patients With Advanced Breast and Lung Cancers (Study P04716)
A Randomized Phase 2 Study of SCH 727965 in Subjects With Advanced Breast and Non Small Cell Lung (NSCLC) Cancers
1 other identifier
interventional
97
0 countries
N/A
Brief 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. The study will also determine the activity of SCH 727965 treatment in participants who experience cancer progression after standard treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2008
Typical duration for phase_2
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
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 8, 2008
CompletedFirst Posted
Study publicly available on registry
August 12, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedAugust 5, 2015
August 1, 2015
2.9 years
August 8, 2008
August 4, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Time to disease progression.
Date of randomization to date of tumor progression.
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).
Every 6 weeks for 30 weeks, and then every 9 weeks.
Study Arms (6)
Breast cancer randomized to SCH 727965
EXPERIMENTALBreast cancer randomized to capecitabine
ACTIVE COMPARATORSCH 727965 in breast cancer after progression on capecitabine
EXPERIMENTALNSCLC randomized to SCH 727965
EXPERIMENTALNote: Enrollment of participants with NSCLC was completed per protocol as of 26 JAN 2010
NSCLC randomized to erlotinib
ACTIVE COMPARATORNote: Enrollment of participants with NSCLC was completed per protocol as of 26 JAN 2010
SCH 727965 in NSCLC after progression on erlotinib
EXPERIMENTALNote: Crossover to SCH 727965 after progression on erlotinib was completed per protocol as of 26 JAN 2010
Interventions
SCH 727965 50 mg/m\^2 IV on Day 1 of each 21 day cycle until disease progression.
Capecitabine 1250 mg/m\^2 orally twice daily from Day 1 to Day 14 of each 21 day cycle until disease progression.
Erlotinib 150 mg orally once daily until disease progression.
Eligibility Criteria
You may qualify if:
- 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).
- 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.
You may not qualify if:
- 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:
- known dihydropyrimidine dehydrogenase deficiency,
- previous treatment with capecitabine.
- NSCLC: previous treatment with erlotinib.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
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.
PMID: 24393852RESULTStephenson 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.
PMID: 24388167RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2008
First Posted
August 12, 2008
Study Start
July 1, 2008
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
August 5, 2015
Record last verified: 2015-08