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

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT00732810
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Aug 12, 2008
Start date
Jul 31, 2008
Status verified
Aug 2015
Primary completion
Jun 30, 2011
Completion
Jun 30, 2011

Study Design

Enrollment
97 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Breast cancer randomized to SCH 727965
  • Active Comparator: Breast cancer randomized to capecitabine
  • Experimental: SCH 727965 in breast cancer after progression on capecitabine
  • Experimental: NSCLC randomized to SCH 727965
    Note: Enrollment of participants with NSCLC was completed per protocol as of 26 JAN 2010
  • Active Comparator: NSCLC randomized to erlotinib
    Note: Enrollment of participants with NSCLC was completed per protocol as of 26 JAN 2010
  • 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

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. ]

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