AZD9833 China PK Study

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: ER+, HER2-, Metastatic Breast Cancer

Treatments: Drug: AZD9833 with everolimus; Drug: AZD9833; Drug: AZD9833 with palbociclib

Study type: Interventional

Funder types: Industry

Identifiers

NCT04818632

D8530C00007

Details and patient eligibility

About

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

Full 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

Enrollment: 28 patients

Sex: Female

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Any menopausal status:

   1. 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.
   2. Post-menopausal defined according to standard criteria in the protocol.

2. Histological or cytological confirmation of adenocarcinoma of the breast.

3. Documented positive ER status and HER2 negative status of primary or metastatic tumour tissue.

4. ECOG performance status 0 to 1.

5. Metastatic disease and radiological or objective evidence of progression on or after the last systemic therapy prior to the start of study intervention.

6. 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.

7. Recurrence or progression on at least one line of endocrine therapy in the metastatic disease setting.

8. For Part A and Part B cohort 1, patients should be eligible for SERD monotherapy treatment.

9. 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.

10. 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

1. Previous treatment with AZD9833.
2. Presence of life-threatening metastatic visceral disease, uncontrolled CNS metastatic disease or life-threatening extensive hepatic involvement.
3. 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.
4. Inadequate bone marrow reserve or organ function.
5. Any clinically important and symptomatic heart disease.
6. Any concurrent anti-cancer treatment.
7. 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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28 participants in 4 patient groups

AZD9833 monotherapy dose escalation

Experimental group

Treatment:

Drug: AZD9833

Drug: AZD9833

AZD9833 monotherapy dose expansion

Experimental group

Treatment:

Drug: AZD9833

Drug: AZD9833

AZD9833 with palbociclib dose expansion

Experimental group

Treatment:

Drug: AZD9833 with palbociclib

AZD9833 with everolimus dose expansion

Experimental group

Treatment:

Drug: AZD9833 with everolimus