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

NCT ID: NCT00732810

Last Updated: 2015-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 97 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2011-06-30

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.

Conditions

Breast Neoplasms; Carcinoma, Non-Small-Cell Lung

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Breast cancer randomized to SCH 727965

Group Type: EXPERIMENTAL

SCH 727965

Intervention Type: DRUG

SCH 727965 50 mg/m\^2 IV on Day 1 of each 21 day cycle until disease progression.

Breast cancer randomized to capecitabine

Group Type: ACTIVE_COMPARATOR

Capecitabine

Intervention Type: DRUG

Capecitabine 1250 mg/m\^2 orally twice daily from Day 1 to Day 14 of each 21 day cycle until disease progression.

SCH 727965 in breast cancer after progression on capecitabine

Group Type: EXPERIMENTAL

SCH 727965

Intervention Type: DRUG

SCH 727965 50 mg/m\^2 IV on Day 1 of each 21 day cycle until disease progression.

NSCLC randomized to SCH 727965

Note: Enrollment of participants with NSCLC was completed per protocol as of 26 JAN 2010

Group Type: EXPERIMENTAL

SCH 727965

Intervention Type: DRUG

SCH 727965 50 mg/m\^2 IV on Day 1 of each 21 day cycle until disease progression.

NSCLC randomized to erlotinib

Note: Enrollment of participants with NSCLC was completed per protocol as of 26 JAN 2010

Group Type: ACTIVE_COMPARATOR

Erlotinib

Intervention Type: DRUG

Erlotinib 150 mg orally once daily until disease progression.

SCH 727965 in NSCLC after progression on erlotinib

Note: Crossover to SCH 727965 after progression on erlotinib was completed per protocol as of 26 JAN 2010

Group Type: EXPERIMENTAL

SCH 727965

Intervention Type: DRUG

SCH 727965 50 mg/m\^2 IV on Day 1 of each 21 day cycle until disease progression.

Interventions

SCH 727965

SCH 727965 50 mg/m\^2 IV on Day 1 of each 21 day cycle until disease progression.

Intervention Type: DRUG

Capecitabine

Capecitabine 1250 mg/m\^2 orally twice daily from Day 1 to Day 14 of each 21 day cycle until disease progression.

Intervention Type: DRUG

Erlotinib

Erlotinib 150 mg orally once daily until disease progression.

Intervention Type: DRUG

Other Intervention Names

Xeloda; Tarceva

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: RESULT

PMID: 24393852 (View on PubMed)

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 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.

Reference Type: RESULT

PMID: 24388167 (View on PubMed)

Other Identifiers

P04716

Identifier Type: -

Identifier Source: org_study_id