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

August 4, 2015 updated by: Merck Sharp & Dohme LLC

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

97

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to disease progression.
Time Frame: Every 6 weeks for 30 weeks, and then every 9 weeks. Assessments continue until disease progression.
Date of randomization to date of tumor progression.
Every 6 weeks for 30 weeks, and then every 9 weeks. Assessments continue until disease 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.
Percentage of participants with tumor responses (partial responses + complete responses).
Every 6 weeks for 30 weeks, and then every 9 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

August 8, 2008

First Submitted That Met QC Criteria

August 8, 2008

First Posted (Estimate)

August 12, 2008

Study Record Updates

Last Update Posted (Estimate)

August 5, 2015

Last Update Submitted That Met QC Criteria

August 4, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P04716

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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