AZD5305 for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Breast Cancer+18 More
AZD5305 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is testing if a new cancer drug is safe and effective.

Eligible Conditions
  • Breast Cancer
  • Malignant Neoplasm of Pancreas
  • Prostate Cancer
  • Non-small Cell Lung Cancer
  • Bladder Cancer, Cancer
  • Malignant Neoplasm of Stomach
  • Ovarian Cancer
  • Small Cell Lung Cancer (SCLC)
  • Cervical Cancers
  • Endometrial Cancer
  • Additional Indications Below for Module 4 and 5
  • Colorectal Carcinoma
  • Biliary Cancers

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Breast Cancer

Study Objectives

2 Primary · 29 Secondary · Reporting Duration: From Screening to confirmed progressive disease (approximately 1 year)

Week 12
Module 1: Area Under Curve (AUC)
Module 1: Maximum plasma concentration of the drug (Cmax)
Module 1: The time taken to reach the maximum concentration (Tmax)
Module 2: Area Under Curve (AUC)
Module 2: Maximum plasma concentration of the drug (Cmax)
Module 2: The time taken to reach the maximum concentration (Tmax)
Module 3: Area Under Curve (AUC)
Module 3: Maximum plasma concentration of the drug (Cmax)
Module 3: The time taken to reach the maximum concentration (Tmax)
Module 4 : Area Under Curve
Module 4: Maximum plasma concentration of the drug (Cmax)
Module 4: The time taken to reach the maximum concentration (Tmax)
Module 5: Area Under Curve
Module 5: Maximum plasma concentration of the drug (Cmax)
Module 5: The time taken to reach the maximum concentration (Tmax)
Day 28
Module 1 : To investigate the effect of a high-fat meal on the PK of AZD5305
Day 21
Effects of AZD5305 on Ph2AX (Ser139) PD biomarker
Year 1
Best percentage change in target lesion
CA125 response (ovarian cancer)
Duration of Response
Module 1 and Module 5: Objective Response Rate (prostate cancer)
Module 1: Objective Response Rate(prostate cancer)
Module 1: Proportion of subjects with ≥ 50% PSA decrease (prostate cancer)
Module 1: Radiographic progression free survival (prostate cancer)
Objective Response Rate
Progression Free Survival
Time To Response
From first dose of study treatment until the end of Cycle 1.
The number of subjects with dose-limiting toxicity (DLT), as defined in the protocol.
Year 1
The number of subjects with adverse events/serious adverse events
Day 40
Module 4: Anti-Drug Antibody (ADA)
Day 28
Module 5: Anti-Drug Antibody (ADA)

Trial Safety

Safety Progress

1 of 3

Other trials for Breast Cancer

Trial Design

5 Treatment Groups

Module 5 AZD5305 + Datopotamab Deruxtecan
1 of 5
Module 3: AZD5305 + Carboplatin with or without Paclitaxel
1 of 5
Module 2: AZD5305 + Paclitaxel
1 of 5
Module 4: AZD5305 + Trastuzumab Deruxtecan
1 of 5
Module 1: AZD5305 Monotherapy
1 of 5
Experimental Treatment

715 Total Participants · 5 Treatment Groups

Primary Treatment: AZD5305 · No Placebo Group · Phase 1 & 2

Module 5 AZD5305 + Datopotamab DeruxtecanExperimental Group · 2 Interventions: Dato-DXd, AZD5305 · Intervention Types: Drug, Drug
Module 3: AZD5305 + Carboplatin with or without PaclitaxelExperimental Group · 3 Interventions: Carboplatin, AZD5305, Paclitaxel · Intervention Types: Drug, Drug, Drug
Module 2: AZD5305 + PaclitaxelExperimental Group · 2 Interventions: AZD5305, Paclitaxel · Intervention Types: Drug, Drug
Module 4: AZD5305 + Trastuzumab DeruxtecanExperimental Group · 2 Interventions: T- Dxd, AZD5305 · Intervention Types: Drug, Drug
Module 1: AZD5305 Monotherapy
Drug
Experimental Group · 1 Intervention: AZD5305 · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
FDA approved
Paclitaxel
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from screening to confirmed progressive disease (approximately 1 year)

Who is running the clinical trial?

AstraZenecaLead Sponsor
3,956 Previous Clinical Trials
91,808,146 Total Patients Enrolled
157 Trials studying Breast Cancer
1,235,179 Patients Enrolled for Breast Cancer
Timothy YapPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
158 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a performance status of 0-2.
You have a life expectancy ≥ 12 weeks.\n
You have an adequate organ and marrow function as defined by the protocol.
For Part B expansion cohorts: Provision of formalin-fixed and paraffin-embedded (FFPE) tumour specimen is mandatory, where available, except if stated that it is optional in a specific Module.
Patients must not have received prior therapy with a PARPi-based regimen (either as a treatment or as maintenance).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 16th, 2021

Last Reviewed: October 24th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.