Testing Palbociclib (PD-0332991) as Potentially Targeting Treatment in Cancers With CDK4 or CDK6 Amplification (MATCH - Subprotocol Z1C)

Arms (1)

1. type

   EXPERIMENTAL

   label

   Treatment (palbociclib)

   description

   Patients receive palbociclib PO QD on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT or MRI and blood sample collection throughout the trial. Patients may also undergo a biopsy on study.

   interventionNames

   1. Procedure: Biopsy Procedure
   2. Procedure: Biospecimen Collection
   3. Procedure: Computed Tomography
   4. Procedure: Magnetic Resonance Imaging
   5. Drug: Palbociclib

Primary outcomes (1)

1. measure

   Objective Response Rate (ORR)

   timeFrame

   Tumor assessments occurred at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration

   description

   ORR is defined as the percentage of patients whose tumors have a complete or partial response to treatment among analyzable patients. Objective response is defined consistent with Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. Details about how to define complete response and partial response can be found in the master protocol. 90% two-sided binomial exact confidence interval is calculated for ORR.