Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as PF-07220060, PF-07220060 CDK4 inhibitor
Atirmociclib · 2 trials · 4 indications
Maximum observed plasma concentration (Cmax) for atirmociclib following a single oral dose in participants with normal hepatic function
Maximum observed plasma concentration (Cmax) for atirmociclib following a single oral dose in participants with hepatic impairment
AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Dose-normalized plasma AUCinf and Cmax of atirmociclib for each cohort (AUClast if AUCinf cannot be estimated)
| Arm | Type | Description |
|---|---|---|
| Group 1: Normal Hepatic Function | EXPERIMENTAL | Atirmociclib administered as a single oral dose |
| Group 4: Severe Hepatic Impairment | EXPERIMENTAL | Atirmociclib administered as a single oral dose |
| Group 3: Moderate Hepatic Impairment | EXPERIMENTAL | Atirmociclib administered as a single oral dose |
| Group 2: Mild Hepatic Impairment | EXPERIMENTAL | Atirmociclib administered as a single oral dose |
| Cohort 1 | EXPERIMENTAL | In Period 1 Day 1, participants from Sequence AB and BA will receive Dose A and Dose B atirmociclib higher drug load IR MST tablet, respectively. In Period 2 Day 1, the participants from two sequences in the same cohort will shuffle the treatment. |
| Cohort 6 | EXPERIMENTAL | In Period 1 Day 1, participants from Sequence CD and DC will receive Dose C and Dose D atirmociclib higher drug load IR MST tablets, respectively. In Period 2 Day 1, the participants from two sequences in the same cohort will shuffle the treatment. |
| Cohort 2 | EXPERIMENTAL | In Period 1 Day 1, participants from Sequence AC and CA will receive Dose A and Dose C atirmociclib higher drug load IR MST tablet, respectively. In Period 2 Day 1, the participants from two sequences in the same cohort will shuffle the treatment. |
| Cohort 4 | EXPERIMENTAL | In Period 1 Day 1, participants from Sequence AD and DA will receive Dose A and Dose D atirmociclib higher drug load IR MST tablet, respectively. In Period 2 Day 1, the participants from two sequences in the same cohort will shuffle the treatment. |
| Cohort 3 | EXPERIMENTAL | In Period 1 Day 1, participants from Sequence BC and CB will receive Dose B and Dose C atirmociclib higher drug load IR MST tablets, respectively. In Period 2 Day 1, the participants from two sequences in the same cohort will shuffle the treatment. |
| Cohort 5 | EXPERIMENTAL | In Period 1 Day 1, participants from Sequence BD and DB will receive Dose B and Dose D atirmociclib higher drug load IR MST tablets, respectively. In Period 2 Day 1, the participants from two sequences in the same cohort will shuffle the treatment. |
| Name | Type | Description |
|---|---|---|
| Atirmociclib | DRUG | atirmociclib administered as a single oral dose |
| atirmociclib (PF-07220060) | DRUG | Open-label, two-period, cross-over study to evaluate dose proportionality of atirmociclib (PF-07220060) pharmacokinetics when administered under fed condition to healthy participants |
Inclusion criteria including but not limited to: * BMI of 17.5-40 kg/m2; and a total body weight \>50 kg (110 lb). * Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. * Capable of giving signed informed cons...
Atirmociclib is an investigational small molecule being studied for use in advanced or metastatic breast cancer, liposarcoma, prostate cancer, and adenocarcinoma of the lung. It is also being evaluated in healthy participants for drug interaction studies. Atirmociclib is not yet approved and remains in clinical development.
Atirmociclib is a CDK inhibitor, belonging to the -ciclib class of drugs that target cyclin-dependent kinases. It is being studied for its potential role in treating certain cancers by interfering with cell cycle progression.
Atirmociclib is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. Pfizer is conducting clinical trials to evaluate the safety and efficacy of this investigational drug.
Atirmociclib is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. Clinical trials are ongoing to assess its safety, tolerability, and potential efficacy in various cancer types.
Atirmociclib is being studied in several clinical trials, including NCT04557449 in advanced solid tumors, NCT06465368 in postmenopausal breast cancer, NCT06760637 in HR-positive HER2-negative breast cancer, and NCT06897683 in healthy adults. These trials are at various stages and are conducted internationally.
Yes, Atirmociclib is also known as PF-07220060. The drug is referred to by this alternative name in clinical trial registries and scientific literature. It is also sometimes listed with combination partners such as PF-07104091 in certain study contexts.