- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04818632
AZD9833 China PK Study (AZD9833)
October 2, 2023 updated by: AstraZeneca
A Phase 1 Dose Escalation and Expansion Study of AZD9833 Alone or in Combination With Palbociclib or Everolimus in Chinese Patients With Oestrogen Receptor Positive (ER+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Metastatic Breast Cancer (mBC)
A Phase 1 Dose Escalation and Expansion Study of AZD9833 Alone or in Combination in Chinese patients with ER Positive, HER2 Negative, Metastatic Breast Cancer
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study is designed to investigate and characterize the safety, tolerability and PK of AZD9833 monotherapy (Part A, Part B-cohort 1) or in combination with palbociclib (optional Part B cohort 2) or everolimus (optional Part B cohort 3) and to explore the preliminary anti-tumour activity in Chinese patients
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Beijing, China, 100142
- Research Site
-
Chengdu, China, 610041
- Research Site
-
Shanghai, China, 200032
- Research Site
-
Wuhan, China, 430022
- Research Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 130 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
Any menopausal status:
- Pre-menopausal women must have commenced treatment with an LHRH agonist at least 4 weeks prior to the start of study intervention and must be willing to continue to receive LHRH agonist therapy for the duration of the study.
- Post-menopausal defined according to standard criteria in the protocol.
- Histological or cytological confirmation of adenocarcinoma of the breast.
- Documented positive ER status and HER2 negative status of primary or metastatic tumour tissue.
- ECOG performance status 0 to 1.
- Metastatic disease and radiological or objective evidence of progression on or after the last systemic therapy prior to the start of study intervention.
- At least one lesion as per RECIST Version 1.1 that can be accurately assessed at baseline and is suitable for repeated assessment by CT, MRI, or plain X-ray or clinical examination.
- Recurrence or progression on at least one line of endocrine therapy in the metastatic disease setting.
- For Part A and Part B cohort 1, patients should be eligible for SERD monotherapy treatment.
- For Part B Cohort 2, patients should be eligible for SERD treatment and CDK4/6 inhibitors, and prior treatment with CDK4/6 inhibitors is not permitted.
- For Part B Cohort 3, patients should be eligible for SERD treatment and mTOR inhibitors, and prior treatment with mTOR inhibitors is not permitted.
Exclusion Criteria:
- Previous treatment with AZD9833.
- Presence of life-threatening metastatic visceral disease, uncontrolled CNS metastatic disease or life-threatening extensive hepatic involvement.
- Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, or infection requiring intravenous antibiotic therapy, which makes it undesirable for the patient to participate in the study or which would jeopardize compliance with the protocol.
- Inadequate bone marrow reserve or organ function.
- Any clinically important and symptomatic heart disease.
- Any concurrent anti-cancer treatment.
- Refractory nausea and vomiting, uncontrolled chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of AZD9833 (and palbociclib and everolimus).
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AZD9833 monotherapy dose escalation
|
Part A: AZD9833 monotherapy dose escalation.
Part B: AZD9833 monotherapy dose expansion
|
Experimental: AZD9833 monotherapy dose expansion
|
Part A: AZD9833 monotherapy dose escalation.
Part B: AZD9833 monotherapy dose expansion
|
Experimental: AZD9833 with palbociclib dose expansion
|
Part B: AZD9833 with palbociclib dose expansion
|
Experimental: AZD9833 with everolimus dose expansion
|
Part B: AZD9833 with everolimus dose expansion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The number of subjects with dose-limiting toxicity, as defined in the protocol.
Time Frame: Minimum observation period 28 days on treatment.
|
Dose-limiting toxicity as described in the protocol that is not related to disease progression, intercurrent illness or concomitant medications and that, despite optimal therapeutic intervention, meets protocol-defined criteria of AZD9833 monotherapy.
[part A only]
|
Minimum observation period 28 days on treatment.
|
The number of subjects with treatment-related adverse events as assessed by CTCAE v5.0.
Time Frame: 6 months after the last patient recruited starts study intervention or 28 days after the final patient discontinues study intervention
|
Data will include clinical observations, ECG parameters, clinical chemistry and haematology and vital signs assessed as the number of subjects with treatment-related adverse events assessed by CTCAE v5.0 of AZD9833 monotherapy.
|
6 months after the last patient recruited starts study intervention or 28 days after the final patient discontinues study intervention
|
Plasma AZD9833 concentrations and derived PK parameters.
Time Frame: At predefined intervals throughout the AZD9833 treatment period (approximately 16 weeks )
|
To characterise the single- and multiple-dose PK of AZD9833 monotherapy.
|
At predefined intervals throughout the AZD9833 treatment period (approximately 16 weeks )
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The number of subjects with treatment-related adverse events as assessed by CTCAE v5.0.
Time Frame: 6 months after the last patient recruited starts study intervention or 28 days after the final patient discontinues study intervention
|
Data will include clinical observations, ECG parameters, clinical chemistry and haematology and vital signs assessed as the number of subjects with treatment-related adverse events assessed by CTCAE v5.0 of AZD9833 administered in combination with palbociclib or everolimus..
|
6 months after the last patient recruited starts study intervention or 28 days after the final patient discontinues study intervention
|
Plasma AZD9833 concentrations and derived PK parameters (for optional expansion cohorts Part B Cohorts 2 and 3 only). Everolimus (whole blood) concentrations and derived PK parameters (for optional expansion cohort Part B Cohort 3 only).
Time Frame: At predefined intervals throughout the AZD9833 treatment period (approximately 16 weeks )
|
To characterise the single- and/or multiple-dose PK of AZD9833 administered in combination with palbociclib, and single- and/or multiple-dose PK of both AZD9833 and everolimus in combination.
|
At predefined intervals throughout the AZD9833 treatment period (approximately 16 weeks )
|
Objective Response Rate
Time Frame: Week 8 and week 16 and week 24 and then every 12 weeks (week 36, 48, 60) until the end of the study (approximately 1 year)
|
Antitumour activity by evaluation of tumour response assessments using Response Evaluation Criteria in Solid Tumours (RECIST 1.1)
|
Week 8 and week 16 and week 24 and then every 12 weeks (week 36, 48, 60) until the end of the study (approximately 1 year)
|
Duration of Response
Time Frame: Week 8 and week 16 and week 24 and then every 12 weeks (weeks 36, 48 and 60) until the end of the study (approximately 1 year)
|
Antitumour activity by evaluation of tumour response assessments using Response Evaluation Criteria in Solid Tumours (RECIST 1.1)
|
Week 8 and week 16 and week 24 and then every 12 weeks (weeks 36, 48 and 60) until the end of the study (approximately 1 year)
|
Clinical benefit rate at 24 weeks
Time Frame: Up to 24 weeks
|
Antitumour activity by evaluation of tumour response assessments using Response Evaluation Criteria in Solid Tumours (RECIST 1.1)
|
Up to 24 weeks
|
Percentage Change in Tumour Size
Time Frame: Week 8 and week 16 and week 24 and then every 12 weeks (weeks 36, 48 and 60) until the end of the study (approximately 1 year)
|
Antitumour activity by evaluation of tumour response assessments using Response Evaluation Criteria in Solid Tumours (RECIST 1.1)
|
Week 8 and week 16 and week 24 and then every 12 weeks (weeks 36, 48 and 60) until the end of the study (approximately 1 year)
|
Progression Free Survival
Time Frame: From start of treatment to disease progression/latest date of evaluable RECIST assessment (approximate 1 year)
|
Antitumour activity by evaluation of tumour response assessments using Response Evaluation Criteria in Solid Tumours (RECIST 1.1)
|
From start of treatment to disease progression/latest date of evaluable RECIST assessment (approximate 1 year)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jiong Wu, Department of Breast Surgery, Fudan University Shanghai Cancer Center
- Principal Investigator: Jian Zhang, Department of Medical Oncology, Fudan University Shanghai Cancer Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 12, 2021
Primary Completion (Actual)
September 7, 2023
Study Completion (Actual)
September 7, 2023
Study Registration Dates
First Submitted
March 24, 2021
First Submitted That Met QC Criteria
March 24, 2021
First Posted (Actual)
March 26, 2021
Study Record Updates
Last Update Posted (Actual)
October 3, 2023
Last Update Submitted That Met QC Criteria
October 2, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Protein Kinase Inhibitors
- MTOR Inhibitors
- Palbociclib
- Everolimus
Other Study ID Numbers
- D8530C00007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD 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.
IPD Sharing 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.
IPD Sharing Access Criteria
When a request has been approved AstraZeneca will provide access to the de-identified 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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on ER+, HER2-, Metastatic Breast Cancer
-
Janssen Research & Development, LLCCompletedPostmenopausal | Metastatic ER+ Her2- Breast CancerUnited States, France, Ukraine, United Kingdom, Belgium, Spain, Netherlands, Korea, Republic of, Russian Federation, Poland, Luxembourg, Ireland
-
AstraZenecaCompletedAdvanced Solid Malignancies | Breast Cancer - ER+, HER2 - | Breast Cancer - ER+, HER2-, PIK3CA Gene MutationUnited States, United Kingdom
-
Shenzhen Yangli Pharmaceutical Technology Co., LtdRecruitingMetastatic Breast Cancer | ER+, HER2- Advanced Breast CancerChina
-
Clovis Oncology, Inc.TerminatedBreast Cancer | Metastatic Breast Cancer | Estrogen Receptor Positive | Triple Negative | HER2 | HER2 Positive | MBC | ERUnited States
-
University of MiamiRecruitingBreast Cancer | Metastatic Breast Cancer | ER-positive Breast Cancer | HER2-negative Breast CancerUnited States
-
Fondazione Sandro PitiglianiClinical Research Technology S.r.l.RecruitingMetastatic Breast Cancer | HER2-negative Breast Cancer | ER Positive Breast CancerItaly
-
Imperial College LondonMedical Research Council; ECMCRecruitingMetastatic Breast Cancer | HER2-negative Breast Cancer | ER Positive Breast CancerUnited Kingdom
-
Massachusetts General HospitalPuma Biotechnology, Inc.; Celcuity, Inc.WithdrawnMetastatic Breast Cancer | Invasive Breast Cancer | HER2-negative Breast Cancer | ER Positive Breast Cancer | PR-Positive Breast Cancer | Stage IV (Metastatic) Breast CancerUnited States
-
Olema Pharmaceuticals, Inc.RecruitingBreast Cancer | Advanced Breast Cancer | Metastatic Breast Cancer | HER2 Negative Breast Carcinoma | ER Positive Breast CancerUnited States, Korea, Republic of, Australia, Taiwan, Hong Kong, Malaysia, Thailand, Argentina, Belgium, Portugal, Italy, Czechia, Mexico, Poland, Germany
-
QuantumLeap Healthcare CollaborativeRecruitingSolid Tumor | Metastatic Cancer | Metastatic Breast Cancer | Triple Negative Breast Cancer | HER2-positive Breast Cancer | Solid Tumor, Adult | Solid Carcinoma | HER2-positive Metastatic Breast Cancer | Progesterone Receptor-positive Breast Cancer | HER2-negative Breast Cancer | Estrogen Receptor Positive... and other conditionsUnited States
Clinical Trials on AZD9833
-
AstraZenecaQuotient SciencesCompletedHealthy VolunteersUnited Kingdom
-
AstraZenecaActive, not recruitingER+ HER2- Advanced Breast CancerJapan
-
AstraZenecaCompletedHepatic ImpairmentUnited States, Bulgaria, Slovakia
-
AstraZenecaActive, not recruitingER+ HER2- Advanced Breast CancerUnited States, Spain, United Kingdom
-
AstraZenecaCompletedHER2-negative Breast CancerMexico, United Kingdom, Georgia
-
AstraZenecaQuotient SciencesCompletedER-positive, HER2-negative Breast CancerUnited Kingdom
-
AstraZenecaActive, not recruitingER-Positive HER2-Negative Breast CancerAustria, Belgium, France, Germany, Italy, United Kingdom, United States, Canada, India, Taiwan, Russian Federation, Korea, Republic of, Hungary, Japan, Mexico, Turkey, China, Malaysia, Spain, Czechia, Portugal, Poland, Norway, Bulgaria, Slovaki... and more
-
AstraZenecaRecruitingER+ HER2- Advanced Breast Cancer | High-grade Serous Ovarian Cancer (HGSOC)United States, United Kingdom, Korea, Republic of, Australia, Spain
-
AstraZenecaActive, not recruitingAdvanced ER-Positive HER2-Negative Breast CancerUnited States, Italy, Spain, Belgium, Poland, Canada, Germany, Korea, Republic of, Russian Federation, France, Israel, Hungary, Portugal, United Kingdom, Georgia, Ukraine
-
AstraZenecaRecruitingER-Positive HER2-Negative Breast CancerUnited States, Israel, Spain, Korea, Republic of, Italy, Poland, Belgium, Norway, Bulgaria, France, Germany, United Kingdom, Japan, Taiwan, Canada, Hungary, Australia, Austria, Portugal, Turkey, Russian Federation, Slovakia, Switzer...