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: April 16, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Breast Neoplasms
Carcinoma, Non-Small-Cell Lung
Drug: SCH 727965
Drug: Capecitabine
Drug: Erlotinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase 2 Study of SCH 727965 in Subjects With Advanced Breast and Non Small Cell Lung (NSCLC) Cancers

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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).


Enrollment: 97
Study Start Date: July 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Breast cancer randomized to SCH 727965 Drug: SCH 727965
SCH 727965 50 mg/m^2 IV on Day 1 of each 21 day cycle until disease progression.
Active Comparator: Breast cancer randomized to capecitabine 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
Experimental: SCH 727965 in breast cancer after progression on capecitabine Drug: SCH 727965
SCH 727965 50 mg/m^2 IV on Day 1 of each 21 day cycle until disease progression.
Experimental: NSCLC randomized to SCH 727965
Note: Enrollment of participants with NSCLC was completed per protocol as of 26 JAN 2010
Drug: SCH 727965
SCH 727965 50 mg/m^2 IV on Day 1 of each 21 day cycle until disease progression.
Active Comparator: NSCLC randomized to erlotinib
Note: Enrollment of participants with NSCLC was completed per protocol as of 26 JAN 2010
Drug: Erlotinib
Erlotinib 150 mg orally once daily until disease progression.
Other Name: Tarceva
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
Drug: SCH 727965
SCH 727965 50 mg/m^2 IV on Day 1 of each 21 day cycle until disease progression.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00732810     History of Changes
Other Study ID Numbers: P04716
Study First Received: August 8, 2008
Last Updated: April 16, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Carcinoma
Carcinoma, Non-Small-Cell Lung
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Capecitabine
Erlotinib
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 28, 2014