SCH 727965 in Patients With Advanced Breast and Lung Cancers (Study P04716AM3)
This study has been completed.
Sponsor:
Schering-Plough
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00732810
First received: August 8, 2008
Last updated: June 28, 2011
Last verified: June 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Neoplasms Carcinoma, Non-Small-Cell Lung |
Drug: SCH 727965 Drug: Capecitabine Drug: Erlotinib |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Phase 2 Study of SCH 727965 in Subjects With Advanced Breast and Non Small Cell Lung (NSCLC) Cancers |
Resource links provided by NLM:
Further study details as provided by Schering-Plough:
Primary Outcome Measures:
- Time to disease progression. [ Time Frame: Every 6 weeks for 30 weeks, and then every 9 weeks. Assessments continue until disease progression. ] [ Designated as safety issue: No ]Date of randomization to date of tumor 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. ] [ Designated as safety issue: No ]Percentage of participants with tumor responses (partial responses + complete responses).
| Enrollment: | 97 |
| Study Start Date: | July 2008 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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 Name: 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 Name: 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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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:
- 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.
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Late Stage Development Group Leader, Merck Sharp & Dohme Corp |
| ClinicalTrials.gov Identifier: | NCT00732810 History of Changes |
| Other Study ID Numbers: | P04716 |
| Study First Received: | August 8, 2008 |
| Last Updated: | June 28, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms Carcinoma Carcinoma, Non-Small-Cell Lung Neoplasms by Site Breast Diseases Skin Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms |
Thoracic Neoplasms Lung Diseases Respiratory Tract Diseases Capecitabine Erlotinib Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Protein Kinase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013