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 (CYCAD-1)

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ClinicalTrials.gov Identifier: NCT06188520

Recruitment Status : Recruiting

First Posted : January 3, 2024

Last Update Posted : April 30, 2024

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Sponsor:

Information provided by (Responsible Party):

AstraZeneca

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
ER+ HER2- Advanced Breast Cancer High-grade Serous Ovarian Cancer (HGSOC)	Drug: AZD8421 Drug: Camizestrant Drug: Ribociclib Drug: Palbociclib Drug: Abemaciclib	Phase 1 Phase 2

Detailed Description:

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	204 participants
Allocation:	Non-Randomized
Intervention Model:	Sequential Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	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
Actual Study Start Date :	December 5, 2023
Estimated Primary Completion Date :	June 18, 2025
Estimated Study Completion Date :	June 18, 2025

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Ovarian cancer Breast cancer

Genetic and Rare Diseases Information Center resources: Ovarian Cancer Ovarian Epithelial Cancer

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Module 1 AZD8421 monotherapy	Drug: AZD8421 CDK2 inhibitor
Experimental: Module 2A_abema AZD8421 with camizestrant and abemaciclib	Drug: AZD8421 CDK2 inhibitor Drug: Camizestrant SERD Other Name: AZD9833 Drug: Abemaciclib CDK4/6 inhibitor Other Name: Verzenios
Experimental: Module 2A_ribo AZD8421 with camizestrant and ribociclib	Drug: AZD8421 CDK2 inhibitor Drug: Camizestrant SERD Other Name: AZD9833 Drug: Ribociclib CDK4/6 inhibitor Other Name: Kisqali
Experimental: Module 2A_palbo AZD8421 with camizestrant and palbociclib	Drug: AZD8421 CDK2 inhibitor Drug: Camizestrant SERD Other Name: AZD9833 Drug: Palbociclib CDK4/6 inhibitor Other Name: Ibrance

Outcome Measures

Primary Outcome Measures :

Incidence of dose limiting toxicities (DLTs) as defined in the protocol. [ Time Frame: From start of treatment until the end of DLT period, assessed up to 28 days. ]
Percentage of participants with incidence of DLTs.
Incidence of AEs/SAEs [ Time Frame: From start of treatment until the end of safety follow-up, approximately 18 months. ]
Percentage of participants with incidence of AEs/SAEs.
Clinically significant changes from baseline in clinical laboratory parameters, vital signs and ECGs. [ Time Frame: From start of treatment until the end of safety follow-up, approximately 18 months. ]
Percentage of participants with clinically significant changes from baseline in clinical laboratory parameters, vital signs and ECGs.
Discontinuation of AZD8421 due to toxicity [ Time Frame: From start of treatment until the end of safety follow-up, approximately 18 months. ]
Percentage of participants that have discontinued AZD8421 due to toxicity.

Secondary Outcome Measures :

Overall Response Rate (ORR) [ Time Frame: 8 weeks from start of treatment until end of treatment or objective disease progression, approximately 18 months. ]
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.
Duration of Response (DoR) [ Time Frame: 8 weeks from start of treatment until end of treatment or objective disease progression, approximately 18 months. ]
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).
Disease control rate (DCR) [ Time Frame: 24 weeks after the start of treatment. ]
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.
Percentage change in tumor size [ Time Frame: From start of treatment through to EOT, progressive disease, death (in the absence of progression), start of subsequent anti-cancer therapy, whichever occurs first, approximately 18 months. ]
The largest decrease (or smallest increase) in tumor size from baseline for a participant, using RECIST v1.1 assessments
Progression Free Survival (PFS) [ Time Frame: From start of treatment through to progressive disease, death (in the absence of progression), EOT (last evaluable disease assessment), whichever occurs first, approximately 18 months. ]
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.
PK of AZD8421 (Cmax) [ Time Frame: From start of treatment, at predefined intervals up to Cycle 6, approximately 6 months (each cycle is 28 days) of the administration of AZD8421. ]
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.
PK of AZD8421 (Tmax) [ Time Frame: From start of treatment, at predefined intervals up to Cycle 6, approximately 6 months (each cycle is 28 days) of the administration of AZD8421. ]
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.
PK of AZD8421 (AUCinf) [ Time Frame: From start of treatment, at predefined intervals up to Cycle 6, approximately 6 months (each cycle is 28 days) of the administration of AZD8421. ]
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.
PK of AZD8421 (AUClast) [ Time Frame: From start of treatment, at predefined intervals up to Cycle 6, approximately 6 months (each cycle is 28 days) of the administration of AZD8421. ]
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.
PK of AZD8421 (T1/2λZ) [ Time Frame: From start of treatment, at predefined intervals up to Cycle 6, approximately 6 months (each cycle is 28 days) of the administration of AZD8421. ]
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.
PK of AZD8421 (CL/F) [ Time Frame: From start of treatment, at predefined intervals up to Cycle 6, approximately 6 months (each cycle is 28 days) of the administration of AZD8421. ]
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.
PK of AZD8421 (Cssmax) [ Time Frame: From start of treatment, at predefined intervals up to Cycle 6, approximately 6 months (each cycle is 28 days) of the administration of AZD8421. ]
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.
PK of AZD8421 (Tssmax) [ Time Frame: From start of treatment, at predefined intervals up to Cycle 6, approximately 6 months (each cycle is 28 days) of the administration of AZD8421. ]
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.
PK of AZD8421 (AUC0-tau) [ Time Frame: From start of treatment, at predefined intervals up to Cycle 6, approximately 6 months (each cycle is 28 days) of the administration of AZD8421. ]
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.
PK of AZD8421 (AUCsslast) [ Time Frame: From start of treatment, at predefined intervals up to Cycle 6, approximately 6 months (each cycle is 28 days) of the administration of AZD8421. ]
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.
PK of AZD8421 (T1/2λssz) [ Time Frame: From start of treatment, at predefined intervals up to Cycle 6, approximately 6 months (each cycle is 28 days) of the administration of AZD8421. ]
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.
PK of AZD8421 (CLss/F) [ Time Frame: From start of treatment, at predefined intervals up to Cycle 6, approximately 6 months (each cycle is 28 days) of the administration of AZD8421. ]
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.
PK of AZD8421, camizestrant, and CDK4/6i (Cmax) (M2 only) [ Time Frame: From start of treatment, at predefined intervals up to Cycle 6, approximately 6 months (each cycle is 28 days) of the administration of AZD8421, camizestrant and CDK4/6i. ]
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.
PK of AZD8421, camizestrant, and CDK4/6i (Tmax) (M2 only) [ Time Frame: From start of treatment, at predefined intervals up to Cycle 6, approximately 6 months (each cycle is 28 days) of the administration of AZD8421, camizestrant and CDK4/6i. ]
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.
PK of AZD8421, camizestrant, and CDK4/6i (AUCinf) (M2 only) [ Time Frame: From start of treatment, at predefined intervals up to Cycle 6, approximately 6 months (each cycle is 28 days) of the administration of AZD8421, camizestrant and CDK4/6i. ]
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.
PK of AZD8421, camizestrant, and CDK4/6i (T1/2λ) (M2 only) [ Time Frame: From start of treatment, at predefined intervals up to Cycle 6, approximately 6 months (each cycle is 28 days) of the administration of AZD8421, camizestrant and CDK4/6i. ]
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.
PK of AZD8421, camizestrant, and CDK4/6i (CL/F) (M2 only) [ Time Frame: From start of treatment, at predefined intervals up to Cycle 6, approximately 6 months (each cycle is 28 days) of the administration of AZD8421, camizestrant and CDK4/6i. ]
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.
PK of AZD8421, camizestrant, and CDK4/6i (Cssmax) (M2 only) [ Time Frame: From start of treatment, at predefined intervals up to Cycle 6, approximately 6 months (each cycle is 28 days) of the administration of AZD8421, camizestrant and CDK4/6i. ]
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.
PK of AZD8421, camizestrant, and CDK4/6i (Tssmax) (M2 only) [ Time Frame: From start of treatment, at predefined intervals up to Cycle 6, approximately 6 months (each cycle is 28 days) of the administration of AZD8421, camizestrant and CDK4/6i. ]
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.
PK of AZD8421, camizestrant, and CDK4/6i (AUC0-tau) (M2 only) [ Time Frame: From start of treatment, at predefined intervals up to Cycle 6, approximately 6 months (each cycle is 28 days) of the administration of AZD8421, camizestrant and CDK4/6i. ]
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.
PK of AZD8421, camizestrant, and CDK4/6i (T1/2λssz) (M2 only) [ Time Frame: From start of treatment, at predefined intervals up to Cycle 6, approximately 6 months (each cycle is 28 days) of the administration of AZD8421, camizestrant and CDK4/6i. ]
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.
PK of AZD8421, camizestrant, and CDK4/6i (CLss/F) (M2 only) [ Time Frame: From start of treatment, at predefined intervals up to Cycle 6, approximately 6 months (each cycle is 28 days) of the administration of AZD8421, camizestrant and CDK4/6i. ]
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.
Overall survival (M1 and M2) [ Time Frame: From start of treatment through to death or study completion (last recorded date on which the subject was known to be alive), whichever occurs first, approximately 18 months. ]
To assess the preliminary anti-tumor activity and efficacy of AZD8421 monotherapy/ or in combination with other anticancer drugs
PD of AZD8421 (M1B only) [ Time Frame: From start of treatment, at predefined intervals throughout the administration of AZD8421 until end of treatment, approximately 18 months. ]
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

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Female participants only, aged 18 or above
Participants with advanced solid tumors must have received prior adequate therapy in accordance with local practice for their tumor type and stage of disease, or, in the opinion of the Investigator, a clinical study is the best option for their next treatment based on response to and/or tolerability of prior therapy.
Metastatic or locoregionally recurrent disease and radiological or objective evidence of progression on or after the last systemic therapy prior to starting IMP.
ECOG/WHO performance status 0 to 1, and a minimum life expectancy of 12 weeks.
At least one lesion that is measurable and/or non-measurable, as per RECIST v1.1 and that can be accurately assessed at baseline and is suitable for repeated assessment.

Exclusion Criteria:

Intervention with any of the following:
Any cytotoxic chemotherapy, investigational agents, or other anti-cancer drugs for the treatment of advanced cancer from a previous treatment regimen or clinical study within 14 days or 5 half-lives (whichever is shorter) of the first dose of IMP (21 days for myelosuppressive therapies) other than GnRHa (eg, goserelin) and bone-stabilizing agents (eg, zoledronic acid, denosumab).
Any prescription or non-prescription drugs or other products, including herbal products, known to be moderate or strong inhibitors/inducers of CYP3A4/5 which cannot be discontinued prior to first dose of IMP and withheld throughout the study until 2 weeks after the last dose of study drug.
Drugs that have a known risk of Torsades de Pointes.
Radiotherapy with a limited field of radiation for palliation within 1 week of the first dose of IMP.
Major surgical procedure or significant traumatic injury, within 4 weeks of the first dose of IMP, or an anticipated need for major surgery and/or any surgery requiring general anesthesia during the study.
Any unresolved toxicities of Grade ≥ 2 from prior anti-cancer therapy (with the exception of alopecia). Participants with stable ≤ Grade 2 neuropathy are eligible.
Presence of life-threatening metastatic visceral disease, as judged by the Investigator, uncontrolled CNS metastatic disease. Participants with spinal cord compression and/or brain metastases may be enrolled if definitively treated (eg, surgery or radiotherapy) and stable off steroids for at least 4 weeks prior to start of IMP.
Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, or eg, infection requiring IV antibiotic therapy, or active infection including hepatitis B, hepatitis C, and HIV (active viral infection is defined as requiring antiviral therapy; screening for chronic conditions is not required).
Any of the following cardiac criteria:
Mean resting QTcF > 470 msec obtained from a triplicate ECG
Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG (eg, complete left bundle branch block, second- and third-degree heart block), or clinically significant sinus pause. Participants with controlled atrial fibrillation can be enrolled.
Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as symptomatic heart failure, hypokalemia, congenital long QT syndrome, immediate family history of long QT syndrome or unexplained sudden death at < 40 years of age. Hypertrophic cardiomyopathy and clinically significant stenotic valve disease.
LVEF < 50%, and/or experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, unstable angina pectoris, congestive heart failure NYHA Grade ≥ 2, cerebrovascular accident, or transient ischemic attack.
Uncontrolled hypertension.
Inadequate bone marrow reserve or organ function as demonstrated by relevant laboratory values:
Refractory nausea and vomiting, uncontrolled chronic gastrointestinal diseases, or previous significant bowel resection that would preclude adequate absorption of IMP(s).
History of hypersensitivity to active or inactive excipients of AZD8421 or drugs with a similar chemical structure or class to AZD8421.
Previous treatment with AZD8421 or with any CDK2-selective inhibitor, or protein kinase membrane-associated tyrosine- and threonine-specific cdc2-inhibitory kinase 1 (PKMYT1) inhibitor, or WEE1 inhibitor.
Currently pregnant (confirmed with positive pregnancy test), breast feeding, or planning to become pregnant. Participants of childbearing potential must agree to use one highly effective contraceptive measure.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06188520

Contacts

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Contact: AstraZeneca Clinical Study Information Center	1-877-240-9479	information.center@astrazeneca.com

Locations

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United States, Missouri
Research Site	Recruiting
Saint Louis, Missouri, United States, 63141
United States, Rhode Island
Research Site	Not yet recruiting
Providence, Rhode Island, United States, 02903
United States, Tennessee
Research Site	Recruiting
Nashville, Tennessee, United States, 37201
United States, Texas
Research Site	Recruiting
Houston, Texas, United States, 77030
Australia
Research Site	Recruiting
East Melbourne, Australia, 3002
Korea, Republic of
Research Site	Recruiting
Seoul, Korea, Republic of, 03722
Research Site	Recruiting
Seoul, Korea, Republic of, 06351
Spain
Research Site	Not yet recruiting
Barcelona, Spain, 8035
Research Site	Not yet recruiting
Pamplona, Spain, 31005
United Kingdom
Research Site	Recruiting
Cambridge, United Kingdom, CB2 0XY
Research Site	Not yet recruiting
Leeds, United Kingdom, LS9 7TF
Research Site	Recruiting
London, United Kingdom, EC1A 7BE
Research Site	Not yet recruiting
Manchester, United Kingdom, M20 4BX

Sponsors and Collaborators

AstraZeneca

Investigators

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Study Chair:	Richard Baird, MD, PhD	Cambridge University Hospitals

More Information

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Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT06188520
Other Study ID Numbers:	D8470C00001
First Posted:	January 3, 2024 Key Record Dates
Last Update Posted:	April 30, 2024
Last Verified:	April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	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.
Supporting Materials:	Study Protocol Statistical Analysis Plan (SAP)
Time Frame:	AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria:	When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
URL:	https://astrazenecagroup-dt.pharmacm.com/DT/Home

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Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Palbociclib Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

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