Clinical Trials

Inclusion Criteria:

• Diagnosis of teratoma for which no additional standard surgical or medical therapy exists
• Patients must have completed at least 1 prior line of chemotherapy for germ cell tumor
• Radiographic progression, defined by RECIST v.1.1, after the last cancer treatment and within 12 weeks prior to enrollment, compared with scans within 1 year of enrollment.
• Availability of an archival or newly obtained tumor sample (collected at diagnosis or progression) with accompanying pathology report
• Meaurable or evaluable extra-cranial disease as defined by RECIST v 1.1

Exclusion Criteria:

• Malignant germ cell tumors with mixed histology such as embryonal carcinoma, choriocarcinoma, yolk sac tumor or seminoma
• Pathologic evidence of malignant transformation
• CNS disease unless radiation therapy and/or surgery has been completed and serial evaluation demonstrates stable disease
• Prior treatment with any CDK4/6 inhibitor therapy
• Systemic antineoplastic therapy or any experimental therapy within 3 weeks before the first dose of study drug (6 weeks for prior nitrosoureas, bevacizumab, or mitomycin C)
• Major surgery ≤ 2 weeks or radiotherapy ≤ 4 weeks prior to planned start of study drug or patient has not recovered from major side effects.
• Requirement for treatment with any of the prohibited medications including strong CYP3A inhibitors, strong CYP3A inducers, CYP3A substrates with a narrow therapeutic index, and medications with strong risk of QT prolongation

Other protocol-defined inclusion/exclusion criteria may apply.