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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
97

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 8, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 12, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 5, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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