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ATR Kinase Inhibitor
New Treatments for Prostate Cancer
Phase 2
Waitlist Available
Research Sponsored by Canadian Cancer Trials Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have evidence of castrate resistance with biochemical or radiological disease progression
Patients must be ≥18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing whether a new cancer treatment is effective.
Who is the study for?
Men over 18 with advanced prostate cancer that's resistant to castration and has progressed despite treatment. They must have a life expectancy of at least 6 months, be in good physical condition (ECOG status 0 or 1), and have adequate organ function. Participants need to provide consent for blood tests and tumor sample release, agree to use effective contraception, and be available for follow-up.Check my eligibility
What is being tested?
The trial is testing various drugs like Carboplatin, Durvalumab with Tremelimumab, Adavosertib, Savolitinib, Darolutamide, CFI-400945, Ipatasertib on patients whose tumors show specific DNA abnormalities or biomarkers. The goal is to see which drug works best based on these markers.See study design
What are the potential side effects?
Potential side effects include allergic reactions to the drugs or their ingredients; digestive issues due to oral medication absorption problems; liver complications from pre-existing conditions; hormonal changes requiring steroid use; bone density loss if taking bisphosphonates/denosumab.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is growing despite low testosterone levels.
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I am 18 years old or older.
Select...
My prostate cancer is confirmed and not linked to neuroendocrine tumors.
Select...
My kidneys are working well.
Select...
I am mostly active and my doctors expect me to live 6 months or more.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical benefit rate defined as proportion of patients who had PSA decline ≥ 50%, complete or partial objective response, or Stable disease for ≥ 12 weeks.
Secondary outcome measures
Measure effect of each study drug on PSA decline
Measure effect of each study drug on time to PSA progression
Measure objective response as determined by RECIST 1.1 criteria
+3 moreTrial Design
7Treatment groups
Experimental Treatment
Group I: novel non-steroidal androgen receptor (AR) antagonistExperimental Treatment1 Intervention
Group II: cMET inhibitorExperimental Treatment1 Intervention
Group III: WEE-1 inhibitor - ARM CLOSEDExperimental Treatment1 Intervention
Group IV: Ipatasertib AKT inhibitorExperimental Treatment1 Intervention
Group V: Durvalumab and Tremelimumab immunotherapyExperimental Treatment1 Intervention
Group VI: Carboplatin platinum based chemotherapyExperimental Treatment1 Intervention
Group VII: CFI400945 PLK4 inhibitor - ARM CLOSEDExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CFI-400945
2014
Completed Phase 1
~50
Carboplatin
2014
Completed Phase 3
~6670
Ipatasertib
2011
Completed Phase 3
~2320
Savolitinib
2019
Completed Phase 1
~110
Durvalumab and Tremelimumab
2017
Completed Phase 2
~180
Adavosertib
2015
Completed Phase 2
~570
Darolutamide
2018
Completed Phase 2
~100
Find a Location
Who is running the clinical trial?
Canadian Cancer Clinical Trials NetworkUNKNOWN
1 Previous Clinical Trials
325 Total Patients Enrolled
BC Cancer FoundationOTHER
17 Previous Clinical Trials
8,159 Total Patients Enrolled
3 Trials studying Prostate Cancer
498 Patients Enrolled for Prostate Cancer
Canadian Cancer Trials GroupLead Sponsor
124 Previous Clinical Trials
67,253 Total Patients Enrolled
10 Trials studying Prostate Cancer
6,935 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I will need growth factors during the trial.I have heart problems, uncontrolled high blood pressure, or serious liver issues.My cancer is growing despite low testosterone levels.I am 18 years old or older.My prostate cancer is confirmed and not linked to neuroendocrine tumors.I have had cancer before, but it was either skin cancer treated successfully or any other cancer that has been clear for over 2 years.My brain or spinal cord cancer meets certain conditions.My kidneys are working well.I am mostly active and my doctors expect me to live 6 months or more.I am a man who can father a child and agree to use birth control.I have a digestive system condition.
Research Study Groups:
This trial has the following groups:- Group 1: WEE-1 inhibitor - ARM CLOSED
- Group 2: cMET inhibitor
- Group 3: novel non-steroidal androgen receptor (AR) antagonist
- Group 4: CFI400945 PLK4 inhibitor - ARM CLOSED
- Group 5: Ipatasertib AKT inhibitor
- Group 6: Durvalumab and Tremelimumab immunotherapy
- Group 7: Carboplatin platinum based chemotherapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has additional research been conducted on the combination of Durvalumab and Tremelimumab?
"To date, 549 clinical trials are actively probing the efficacy of Durvalumab and Tremelimumab. Of those studies, 123 have reached Phase 3. Primarily based in Xiamen, Fujian Province, there are 37684 different sites running tests for this medication."
Answered by AI
How many sites are carrying out this clinical experiment?
"This medical trial is recruiting participants from 12 different locations, including the Odette Cancer Centre in Toronto, Juravinski Cancer Centre at Hamilton Health Sciences in Hamilton and Allan Blair Cancer Centre located in Regina."
Answered by AI
Are there any opportunities for participation in this experiment?
"This clinical trial is currently enrolling patients, according to the information posted on clinicaltrials.gov. It was initially listed on December 12th 2017 and last modified on May 9th 2022."
Answered by AI
What is the current sample size of this research endeavor?
"Affirmative. The trial details on clinicaltrials.gov indicate that this medical research is actively recruiting participants, with 500 patients being sought from 12 sites. It was first posted on December 12th 2017 and most recently updated on May 9th 2022."
Answered by AI
What potential risks may be associated with Durvalumab and Tremelimumab?
"Our team at Power evaluated the safety of Durvalumab and Tremelimumab, assigning it a score of 2 due to Phase 2 trial data suggesting some level of security but no evidence for efficacy."
Answered by AI
What medical condition is Durvalumab and Tremelimumab usually prescribed for?
"Durvalumab and Tremelimumab is a common treatment for individuals with advanced disease. It has been used to address malignant neoplasms, stage III non-small cell lung cancer, and other types of illnesses that have not yet been operated on."
Answered by AI
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