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Palbociclib · 1 trial · 3 indications
Intracranial Clinical Benefit is defined by complete response (CR), partial response (PR) or stable disease (SD) in the central nervous system (CNS). The proportion of patients in Cohort 1 with response in the CNS will be presented with a two-sided, 90% confidence interval based on the method of Atkinson and Brown, which allows for the two-stage design.
Intracranial clinical benefit is defined by CR, PR, or SD in the CNS. The proportion of Cohort 2 participants with response in the CNS will be presented with a two-sided, 90% exact binomial confidence interval.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 (Palbociclib) | EXPERIMENTAL | This arm involves screening for eligibility, study treatment and study visits, and follow up. Cohort 1 participants will receive palbociclib daily at a pre-determined dose for 21 days (Day 1-21) per 28-day cycle. Palbociclib is taken orally. Participants may receive study drug as long as they do not meet the criteria for ending treatment (no intolerable side effects and disease is not progressing). Participants will be followed for up to 2 years after their treatment with the study drug ends. Up to 30 participants will be enrolled in Cohort 1. |
| Cohort 2 (Palbociclib in Combination with Pembrolizumab) | EXPERIMENTAL | Cohort 2 involves screening for eligibility, study treatment and study visits, and follow up. Participants in Cohort 2 will receive study drugs palbociclib and pembrolizumab. Palbociclib is taken orally once per day for 21 days (Day 1-21) of each 28-day cycle. Pembrolizumab will be administered as an intravenous (IV) infusion once every 21 days. Participants may receive study drugs as long as they do not meet the criteria for ending treatment (no intolerable side effects and disease is not progressing), and will be followed for up to 2 years after they stop study treatment. Up to 15 participants will be enrolled in Cohort 2. |
| Name | Type | Description |
|---|---|---|
| Palbociclib | DRUG | Administered orally once per day on days 1-21 of 28-day cycles. |
| Pembrolizumab | DRUG | Pembrolizumab is administered via intravenous (IV) infusion at a dose of 200 mg over 30 minutes once every 21 days. Pembrolizumab cycles are 3 weeks (21 days) long in this study, and participants in Cohort 2 can receive pembrolizumab as long as they are receiving study drug palbociclib. |
Inclusion Criteria: * Participants must have histologically or cytologically confirmed disease from any solid tumor (Cohort 1) * Participants must have histologically or cytologically confirmed disease from breast cancer or melanoma (Cohort 2). * Participants must have measurable disease in the CNS...
Palbociclib is being studied for the treatment of metastatic malignant neoplasm to brain, including recurrent and progressive brain metastases. It is currently in Phase 2 clinical development as an investigational therapy for these conditions.
Palbociclib targets cyclin-dependent kinases (CDKs), as indicated by its '-ciclib' drug class. It is a small molecule designed to inhibit these kinases, which play a role in cell cycle regulation, though the specific CDK subtypes are not detailed.
Palbociclib is being developed by Merck & Company, Inc., a pharmaceutical company traded under the ticker symbol MRK on the stock market. The company is conducting clinical trials to evaluate the drug for brain metastases.
Palbociclib is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and efficacy for the studied indications.
Palbociclib is being evaluated in a Phase 2 clinical trial with the identifier NCT02896335, titled 'Palbociclib and Pembrolizumab In Central Nervous System Metastases.' This trial is recruiting participants in the United States and aims to enroll 45 patients with metastatic brain neoplasms.
Palbociclib is not listed as being the same as Ibrance in the available information. The data provided does not include alternative names for this drug, so no equivalence to other brand names can be confirmed.