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A Randomized Phase 2 Study of SCH 727965 in Subjects With Advanced Breast and Non Small Cell Lung (NSCLC) Cancers

Phase 2
18 Years
Not Enrolling
Breast Neoplasms, Carcinoma, Non-Small-Cell Lung

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Trial Information

A Randomized Phase 2 Study of SCH 727965 in Subjects With Advanced Breast and Non Small Cell Lung (NSCLC) Cancers

Inclusion Criteria:

- Age >=18 years, either sex, any race.

- Histologically or cytologically confirmed breast cancer or NSCLC; and radiographic or
clinically advanced disease.


- 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.


- known dihydropyrimidine dehydrogenase deficiency,

- previous treatment with capecitabine.

- NSCLC: previous treatment with erlotinib.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to disease progression.

Outcome Description:

Date of randomization to date of tumor progression.

Outcome Time Frame:

Every 6 weeks for 30 weeks, and then every 9 weeks. Assessments continue until disease progression.

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

July 2008

Completion Date:

June 2011

Related Keywords:

  • Breast Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Breast Neoplasms
  • Neoplasms
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung