SCH 727965 in Patients With Advanced Breast and Lung Cancers (Study P04716)

Breast Neoplasms Clinical Trial

Official title:

A Randomized Phase 2 Study of SCH 727965 in Subjects With Advanced Breast and Non Small Cell Lung (NSCLC) Cancers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00732810
• Other study ID #: P04716
• Status: Completed
• Phase: Phase 2
• First received: August 8, 2008
• Last updated: August 4, 2015
• Start date: July 2008
• Est. completion date: June 2011

Study information

• Verified date: August 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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. The study will also determine the activity of SCH 727965 treatment in participants who experience cancer progression after standard treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• SCH 727965
SCH 727965 50 mg/m^2 IV on Day 1 of each 21 day cycle until disease progression.
• Capecitabine
Capecitabine 1250 mg/m^2 orally twice daily from Day 1 to Day 14 of each 21 day cycle until disease progression.
• Erlotinib
Erlotinib 150 mg orally once daily until disease progression.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & 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 breas — View Citation

Stephenson 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Primary	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.	No