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PARP Inhibitor

AZD5305 for Advanced Cancers (PETRA Trial)

Phase 1 & 2
Recruiting
Led By Timothy Yap
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 at the time of screening
For Part B: Patients must not have received prior therapy with a PARPi-based regimen (either as a treatment or as maintenance)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening to confirmed progressive disease (approximately 1 year)
Awards & highlights

PETRA Trial Summary

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

Who is the study for?
Adults over 18 with advanced solid tumors suitable for the study, who have not had certain treatments like strong CYP3A4 inhibitors or inducers, recent major surgery, or live vaccines. They should have a life expectancy of at least 12 weeks and an ECOG performance status of 0-2.Check my eligibility
What is being tested?
The trial is testing AZD5305 alone or combined with other anti-cancer drugs to see if it's safe and effective against various advanced cancers. It involves patients who may/may not have had previous PARPi-based therapy depending on the part of the study they're in.See study design
What are the potential side effects?
Possible side effects include nausea, vomiting, fatigue, allergic reactions to components in the drug mixtures, potential blood disorders such as pancytopenia (low count of all types of blood cells), and risks associated with organ function impairment.

PETRA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I have never been treated with PARPi-based therapy.
Select...
My cancer is getting worse.
Select...
I can take care of myself and am up and about more than half of the day.

PETRA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening to confirmed progressive disease (approximately 1 year)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening to confirmed progressive disease (approximately 1 year) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The number of subjects with adverse events/serious adverse events
The number of subjects with dose-limiting toxicity (DLT), as defined in the protocol.
Secondary outcome measures
Best percentage change in target lesion
CA125 response (ovarian cancer)
Duration of Response
+30 more

PETRA Trial Design

6Treatment groups
Experimental Treatment
Group I: Module 6 AZD5305 + CamizestrantExperimental Treatment2 Interventions
AZD5305 + Camizestrant
Group II: Module 5 AZD5305 + Datopotamab DeruxtecanExperimental Treatment2 Interventions
AZD5305 + Dato-DXd
Group III: Module 4: AZD5305 + Trastuzumab DeruxtecanExperimental Treatment2 Interventions
AZD5305 + T- DXd
Group IV: Module 3: AZD5305 + Carboplatin with or without PaclitaxelExperimental Treatment3 Interventions
AZD5305 + Carboplatin with or without Paclitaxel
Group V: Module 2: AZD5305 + PaclitaxelExperimental Treatment2 Interventions
AZD5305 + Paclitaxel
Group VI: Module 1: AZD5305 MonotherapyExperimental Treatment1 Intervention
AZD5305 Monotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Camizestrant
2023
Completed Phase 1
~40
Paclitaxel
2011
Completed Phase 4
~5380
Carboplatin
2014
Completed Phase 3
~6670

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,266 Previous Clinical Trials
288,605,178 Total Patients Enrolled
59 Trials studying Prostate Cancer
26,718 Patients Enrolled for Prostate Cancer
Timothy YapPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
87 Total Patients Enrolled

Media Library

AZD5305 (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04644068 — Phase 1 & 2
Prostate Cancer Research Study Groups: Module 6 AZD5305 + Camizestrant, Module 1: AZD5305 Monotherapy, Module 2: AZD5305 + Paclitaxel, Module 3: AZD5305 + Carboplatin with or without Paclitaxel, Module 4: AZD5305 + Trastuzumab Deruxtecan, Module 5 AZD5305 + Datopotamab Deruxtecan
Prostate Cancer Clinical Trial 2023: AZD5305 Highlights & Side Effects. Trial Name: NCT04644068 — Phase 1 & 2
AZD5305 (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04644068 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the standard application of AZD5305?

"AZD5305 is an effective medication for patients struggling with melanoma, neoplasm metastasis, and lymphoma, non-hodgkin."

Answered by AI

What other research projects have used AZD5305?

"City of Hope Comprehensive Cancer Center first began studying AZD5305 in 1997 and, as of now, 1549 trials have been completed. Out of the 1229 active studies, a significant portion are taking place in San Francisco, California."

Answered by AI

Are elderly people eligible to participate in this clinical trial?

"This particular trial is seeking patients that fall between 18-130 years of age, which excludes both children and seniors. In total, there are 330 clinical trials for minors and 7887 for older adults."

Answered by AI

Who qualifies to enroll in this clinical trial and receive the experimental medication?

"This study is looking for 715 individuals with breast cancer that meet the following age, health, and previous treatment criteria: 18-130 years old, Eastern Cooperative Oncology Group Performance status of 0-2, a life expectancy of 12 weeks or more, progressive cancer not responding to prior treatments (up to one line of PARPi-based therapy), and adequate organ and marrow function. For Part B expansion cohorts, FFPE tumour specimens are mandatory where available."

Answered by AI

Are patients still being accepted into this clinical trial?

"Yes, according to the most recent update on clinicaltrials.gov, this trial is still looking for patients. The study was first posted on November 12th 2020 and was last edited on October 31st 2022. In total, 8 different sites are recruiting 715 participants."

Answered by AI

How many research subjects are being recruited for this investigation?

"That is correct, the online information from clinicaltrials.gov does show that this study is looking for more participants. The trial was advertised on 11/12/2020 and has since been edited on 10/31/2022. They are searching for 715 people to join across 8 locations."

Answered by AI

Is this clinical trial taking place in numerous hospitals throughout Canada?

"To participate in this study, it is important to choose a location that is close to you from the 8 available sites. The locations include major cities such as San Francisco and Montreal, as well as more rural areas like Kelowna."

Answered by AI

What is the main goal that researchers are hoping to achieve with this trial?

"The aim of the trial, which will last until the end of the first cycle, is to track adverse events and serious adverse events. Additionally, researchers are looking at objective response rate for prostate cancer patients and the time it takes to reach maximum concentration (Tmax) and maximum plasma concentration (Cmax)."

Answered by AI

Who else is applying?

What site did they apply to?
Research Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
~341 spots leftby Dec 2026