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AZD8421 with camizestrant and abemaciclib

AZD8421 with camizestrant and palbociclib

AZD8421

Camizestrant

Ribociclib

Abemaciclib

AstraZeneca Clinical Study Information Center

Richard Baird, MD, PhD

This study is designed to evaluate AZD8421 alone and in combination with selected targeted anti-cancer drugs in patients with ER+HER2- advanced breast cancer, and patients with metastatic high-grade serious ovarian cancer.

This is a first in-human study of AZD8421 administered to participants with advanced or metastatic solid tumors. The study will evaluate the safety, tolerability, preliminary efficacy, pharmacokinetics, and pharmacodynamics of AZD8421 alone and in combination with selected targeted anti-cancer drugs.

AZD8421 monotherapy (M1) will evaluate the safety, tolerability and pharmacokinetics of AZD8421 as monotherapy to identify a recommended Phase II dose (RP2D) in participants with ER+ HER2- advanced breast cancer previously treated with a CDK4/6i (Parts A and B) and participants with metastatic high-grade serous ovarian cancer previously treated with a platinum-based chemotherapy in the metastatic setting (Part B).

AZD8421 combination therapy (M2) will evaluate the safety, tolerability, and pharmacokinetics of AZD8421 in combination with a CDK4/6 inhibitor (one or more of abemaciclib, ribociclib and palbociclib) and camizestrant (next generation oral SERD; referred to throughout as 'camizestrant') in participants with ER+ HER2- advanced breast cancer previously treated with a CDK4/6 inhibitor.

A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors

A Phase I/IIa, First-in-human, Open-label, Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Percentage of participants with incidence of DLTs.

Percentage of participants with incidence of AEs/SAEs.

Percentage of participants with clinically significant changes from baseline in clinical laboratory parameters, vital signs and ECGs.

Percentage of participants that have discontinued AZD8421 due to toxicity.

The percentage of participants with a confirmed Complete Response (CR) or Partial Response (PR), according to RECIST v1.1, that occur prior to disease progression and/or initiation of subsequent anti-cancer therapy.

The time from the date of first documented objective response (which is subsequently confirmed) until date of first documented disease progression or death (by any cause in the absence of disease progression).

The percentage of participants who have a best objective response of confirmed CR or PR or who have SD for at least 23 weeks after start of treatment.

The largest decrease (or smallest increase) in tumor size from baseline for a participant, using RECIST v1.1 assessments

Progression-free survival is defined as the time from the start of treatment until the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the participant withdraws from therapy or receives another anti-cancer therapy prior to progression.

To characterize the PK profiles and parameters of AZD8421 and its metabolites after monotherapy and also in combination with other anti-cancer drugs after single and multiple doses when administered to participants with ER+ HER2- metastatic breast cancer and other advanced solid tumors.

Descriptive statistics of following PK parameters:

After single dose; Cmax; to measure maximum plasma concentration after oral administration.

To characterize the PK profiles and parameters of AZD8421 and its metabolites after monotherapy and also in combination with other anti-cancer drugs after single and multiple doses when administered to participants with ER+ HER2- metastatic breast cancer and other advanced solid tumors.

Descriptive statistics of following PK parameters:

After single dose; Tmax; to measure time to reach maximum plasma concentration.

To characterize the PK profiles and parameters of AZD8421 and its metabolites after monotherapy and also in combination with other anti-cancer drugs after single and multiple doses when administered to participants with ER+ HER2- metastatic breast cancer and other advanced solid tumors.

Descriptive statistics of following PK parameters:

After single dose; AUCinf; to measure the area under the plasma concentration-time curve from time 0 to infinity.

To characterize the PK profiles and parameters of AZD8421 and its metabolites after monotherapy and also in combination with other anti-cancer drugs after single and multiple doses when administered to participants with ER+ HER2- metastatic breast cancer and other advanced solid tumors.

Descriptive statistics of following PK parameters:

After single dose; AUClast; to measure area under the plasma concentration-time curve from time zero to last PK sample.

To characterize the PK profiles and parameters of AZD8421 and its metabolites after monotherapy and also in combination with other anti-cancer drugs after single and multiple doses when administered to participants with ER+ HER2- metastatic breast cancer and other advanced solid tumors.

Descriptive statistics of following PK parameters:

After single dose; T1/2λZ; to measure the terminal elimination half-life.

To characterize the PK profiles and parameters of AZD8421 and its metabolites after monotherapy and also in combination with other anti-cancer drugs after single and multiple doses when administered to participants with ER+ HER2- metastatic breast cancer and other advanced solid tumors.

Descriptive statistics of following PK parameters:

After single dose; CL/F; to measure apparent clearance after oral administration.

To characterize the PK profiles and parameters of AZD8421 and its metabolites after monotherapy and also in combination with other anti-cancer drugs after single and multiple doses when administered to participants with ER+ HER2- metastatic breast cancer and other advanced solid tumors.

Descriptive statistics of following PK parameters:

After multiple doses; Cssmax; to measure maximum concentration after oral administration at steady state.

To characterize the PK profiles and parameters of AZD8421 and its metabolites after monotherapy and also in combination with other anti-cancer drugs after single and multiple doses when administered to participants with ER+ HER2- metastatic breast cancer and other advanced solid tumors.

Descriptive statistics of following PK parameters:

After multiple doses; Tssmax; to measure time it takes to achieve maximum plasma concentration at steady state.

To characterize the PK profiles and parameters of AZD8421 and its metabolites after monotherapy and also in combination with other anti-cancer drugs after single and multiple doses when administered to participants with ER+ HER2- metastatic breast cancer and other advanced solid tumors.

Descriptive statistics of following PK parameters:

After multiple doses; AUC0-tau; to measure area under plasma-concentration time cure within dosing interval.

To characterize the PK profiles and parameters of AZD8421 and its metabolites after monotherapy and also in combination with other anti-cancer drugs after single and multiple doses when administered to participants with ER+ HER2- metastatic breast cancer and other advanced solid tumors.

Descriptive statistics of following PK parameters:

After multiple doses; AUCsslast; to measure the area under plasma-concentration time curve from time zero to last PK sample at steady state.

To characterize the PK profiles and parameters of AZD8421 and its metabolites after monotherapy and also in combination with other anti-cancer drugs after single and multiple doses when administered to participants with ER+ HER2- metastatic breast cancer and other advanced solid tumors.

Descriptive statistics of following PK parameters:

After multiple doses; T1/2λssz; to measure terminal elimination half-life at steady state.

To characterize the PK profiles and parameters of AZD8421 and its metabolites after monotherapy and also in combination with other anti-cancer drugs after single and multiple doses when administered to participants with ER+ HER2- metastatic breast cancer and other advanced solid tumors.

Descriptive statistics of following PK parameters:

After multiple doses; CLss/F; to measure apparent oral clearance at steady state.

Evaluate pharmacokinetics profiles of AZD8421, camizestrant, and CDK4/6i when administered in combination.

For AZD8421 and where possible CDK4/6i and their metabolites, and camizestrant; descriptive statistics of the following PK parameters:

After single dose: Cmax; to measure maximum plasma concentration after oral administration.

Evaluate pharmacokinetics profiles of AZD8421, camizestrant, and CDK4/6i when administered in combination.

For AZD8421 and where possible CDK4/6i and their metabolites, and camizestrant; descriptive statistics of the following PK parameters:

After single dose: Tmax; to measure the time it takes to achieve maximum plasma concentration after oral administration.

Evaluate pharmacokinetics profiles of AZD8421, camizestrant, and CDK4/6i when administered in combination.

For AZD8421 and where possible CDK4/6i and their metabolites, and camizestrant; descriptive statistics of the following PK parameters:

After single dose: AUCinf; to measure area under plasma concentration-time curve from time zero to infinity.

Evaluate pharmacokinetics profiles of AZD8421, camizestrant, and CDK4/6i when administered in combination.

For AZD8421 and where possible CDK4/6i and their metabolites, and camizestrant; descriptive statistics of the following PK parameters:

After single dose: T1/2λZ; to measure terminal elimination half-life.

Evaluate pharmacokinetics profiles of AZD8421, camizestrant, and CDK4/6i when administered in combination.

For AZD8421 and where possible CDK4/6i and their metabolites, and camizestrant; descriptive statistics of the following PK parameters:

After single dose: CL/F; to measure apparent clearance after oral administration.

Evaluate pharmacokinetics profiles of AZD8421, camizestrant, and CDK4/6i when administered in combination.

For AZD8421 and where possible CDK4/6i and their metabolites, and camizestrant; descriptive statistics of the following PK parameters:

After multiple doses: Cssmax; to measure the maximum plasma concentration after oral administration at steady state.

Evaluate pharmacokinetics profiles of AZD8421, camizestrant, and CDK4/6i when administered in combination.

For AZD8421 and where possible CDK4/6i and their metabolites, and camizestrant; descriptive statistics of the following PK parameters:

After multiple doses: Tssmax; to measure time it takes to achieve maximum plasma concentration after oral administration at steady state.

Evaluate pharmacokinetics profiles of AZD8421, camizestrant, and CDK4/6i when administered in combination.

For AZD8421 and where possible CDK4/6i and their metabolites, and camizestrant; descriptive statistics of the following PK parameters:

After multiple doses: AUC0-tau; to measure area under plasma-concentration-time curve within dosing interval.

Evaluate pharmacokinetics profiles of AZD8421, camizestrant, and CDK4/6i when administered in combination.

For AZD8421 and where possible CDK4/6i and their metabolites, and camizestrant; descriptive statistics of the following PK parameters:

After multiple doses: T1/2λssz; to measure terminal elimination half-life at steady state.

Evaluate pharmacokinetics profiles of AZD8421, camizestrant, and CDK4/6i when administered in combination.

For AZD8421 and where possible CDK4/6i and their metabolites, and camizestrant; descriptive statistics of the following PK parameters:

After multiple doses: CLss/F; to measure apparent clearance after oral administration at steady state.

To assess the preliminary anti-tumor activity and efficacy of AZD8421 monotherapy/ or in combination with other anticancer drugs

To assess pharmacodynamic activity of AZD8421 monotherapy by assessment of candidate biomarkers in baseline and on-treatment tumor samples in participants with ER+ HER2- metastatic breast cancer and other advanced solid tumors.

* Tumor protein analysis of candidate biomarkers.
* Tumor assessment including, but not limited to:

  * Genomic profiling
  * Transcriptomic analysis
  * Proteomics
  * Epigenetic analyses
  * Immune profiling

Spots Global Cancer Trial Database for azd8421

Every month we try and update this database with for azd8421 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for azd8421

Every month we try and update this database with for azd8421 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for azd8421 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.