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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00732810
First received: August 8, 2008
Last updated: August 25, 2014
Last verified: August 2014

August 8, 2008
August 25, 2014
July 2008
June 2011   (final data collection date for 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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    Percentage of participants with tumor responses (partial responses + complete responses).
  • Time to disease progression. [ Time Frame: Every 6 weeks for 30 weeks, and then every 9 weeks. Assessments continue until disease progression. ] [ Designated as safety issue: No ]
  • Overall response rate in subjects treated with SCH 727965 after disease progression on the comparator drug. [ Time Frame: Every 6 weeks for 30 weeks, and then every 9 weeks. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00732810 on ClinicalTrials.gov Archive Site
Not Provided
  • Overall response rate of initial treatment with SCH 727965 or a comparator drug (capecitabine for breast cancer or erlotinib for NSCLC). [ Time Frame: Every 6 weeks for 30 weeks, and then every 9 weeks. ] [ Designated as safety issue: No ]
  • Time to disease progression in subjects treated with SCH 727965 after disease progression on the comparator drug. [ Time Frame: Every 6 weeks for 30 weeks, and then every 9 weeks. ] [ Designated as safety issue: No ]
  • Early PET scan response. [ Time Frame: Pretreatment and posttreatment. ] [ Designated as safety issue: No ]
  • Plasma concentration profiles of SCH 727965 [ Time Frame: Cycle 1, Cycle 2, and Cycle 3. ] [ Designated as safety issue: No ]
  • Safety and tolerability of SCH 727965. [ Time Frame: Safety will be assessed at each visit. ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Breast Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Drug: SCH 727965
    SCH 727965 50 mg/m^2 IV on Day 1 of each 21 day cycle until disease progression.
  • Drug: Capecitabine
    Capecitabine 1250 mg/m^2 orally twice daily from Day 1 to Day 14 of each 21 day cycle until disease progression.
    Other Name: Xeloda
  • Drug: Erlotinib
    Erlotinib 150 mg orally once daily until disease progression.
    Other Name: Tarceva
  • Experimental: Breast cancer randomized to SCH 727965
    Intervention: Drug: SCH 727965
  • Active Comparator: Breast cancer randomized to capecitabine
    Intervention: Drug: Capecitabine
  • Experimental: SCH 727965 in breast cancer after progression on capecitabine
    Intervention: Drug: SCH 727965
  • Experimental: NSCLC randomized to SCH 727965
    Note: Enrollment of participants with NSCLC was completed per protocol as of 26 JAN 2010
    Intervention: Drug: SCH 727965
  • Active Comparator: NSCLC randomized to erlotinib
    Note: Enrollment of participants with NSCLC was completed per protocol as of 26 JAN 2010
    Intervention: Drug: Erlotinib
  • Experimental: 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
    Intervention: Drug: SCH 727965
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
97
June 2011
June 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00732810
P04716
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP