None listed
Conditions
Interventions
Group 1 Type of group
SCH 727965 50 mg/m^2 IV on Day 1 of each 21 day cycle until disease progression.
Group name:Group 6 Type of group
SCH 727965 50 mg/m^2 IV on Day 1 of each 21 day cycle until disease progression.
Sponsors
SCHERING PLOUGH RESEARCH INSTITUTE,
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion 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
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.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Percentage of participants with tumor responses (partial responses + complete responses). Measure:Overall response rate in participants treated with SCH 727965 after disease progression on the comparator drug Timepoints:Cada 6 semanas durante 30 semanas, y luego cada 9 semanas. ; Outcome name:the time that elapses between the date the first dose of SCH 727965 is administered after the change of treatment and the first date on which the progression of the disease is verified or the subject dies from that cause. Measure:TPE of subjects who go from treatment with the reference drug to treatment with SCH 727965 Timepoints:During the study | — |
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Date of randomization to date of tumor progression. Measure:Time to disease progression Timepoints:Every 6 weeks for 30 weeks, and then every 9 weeks. Assessments continue until disease progression. | — |
Countries
Canada, Peru, United States
Contacts
Public ContactFrancisco Mendez
SCHERING PLOUGH DEL PERU S.A.
Outcome results
None listed