Clinical trial · Interventional
SCH 727965 in Patients With Advanced Breast and Lung Cancers (Study P04716)
A Randomized Phase 2 Study of SCH 727965 in Subjects With Advanced Breast and Non Small Cell Lung (NSCLC) Cancers
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Erlotinib | Drug | Erlotinib | ALIAS |
| SCH 727965 | Drug | Dinaciclib | ALIAS |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Breast cancer randomized to SCH 727965
- interventionNames
- Drug: SCH 727965
- type
- ACTIVE_COMPARATOR
- label
- Breast cancer randomized to capecitabine
- interventionNames
- Drug: Capecitabine
- type
- EXPERIMENTAL
- label
- SCH 727965 in breast cancer after progression on capecitabine
- interventionNames
- Drug: SCH 727965
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- RESULTMita MM, Joy AA, Mita A, Sankhala K, Jou YM, Zhang D, Statkevich P, Zhu Y, Yao SL, Small K, Bannerji R, Shapiro CL. Randomized phase II trial of the cyclin-dependent kinase inhibitor dinaciclib (MK-7965) versus capecitabine in patients with advanced breast cancer. Clin Breast Cancer. 2014 Jun;14(3):169-76. doi: 10.1016/j.clbc.2013.10.016. Epub 2013 Oct 26. PMID 24393852
- RESULTStephenson JJ, Nemunaitis J, Joy AA, Martin JC, Jou YM, Zhang D, Statkevich P, Yao SL, Zhu Y, Zhou H, Small K, Bannerji R, Edelman MJ. Randomized phase 2 study of the cyclin-dependent kinase inhibitor dinaciclib (MK-7965) versus erlotinib in patients with non-small cell lung cancer. Lung Cancer. 2014 Feb;83(2):219-23. doi: 10.1016/j.lungcan.2013.11.020. Epub 2013 Dec 2. PMID 24388167