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PARP Inhibitor
Senaparib for Prostate Cancer
Phase 2
Waitlist Available
Research Sponsored by Impact Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male ≥18 years of age on the day of signing the ICF.
Patients have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 80 weeks
Awards & highlights
Study Summary
This trial is testing a new drug for prostate cancer that has become resistant to hormone therapy and has spread. The drug is being tested in patients whose cancer has a particular genetic feature.
Who is the study for?
This trial is for men over 18 with advanced prostate cancer resistant to castration and who have specific genetic changes after chemotherapy. They must be in fair health, agree to use contraception, and not have had certain treatments or conditions that could interfere with the study.Check my eligibility
What is being tested?
The trial tests Senaparib's effectiveness and safety against a placebo in men whose prostate cancer has spread and doesn't respond to hormone therapy anymore. These patients also have gene alterations related to DNA repair after Docetaxel treatment.See study design
What are the potential side effects?
While the side effects of Senaparib are not detailed here, similar drugs can cause nausea, fatigue, blood cell count issues, shortness of breath, appetite loss, and potential allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a man aged 18 or older.
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I am able to get out of my bed or chair and move around.
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I am castrated with low testosterone levels and if on hormone therapy, will continue it during the study.
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My prostate cancer has been confirmed by a lab test.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 80 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~80 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Cmax
OS
Objective response rate (ORR) according to RECIST v1.1 assessed by BICR
+9 moreSide effects data
From 2015 Phase 2 & 3 trial • 149 Patients • NCT0196846020%
NAUSEA
16%
SOMNOLENCE
10%
DIZZINESS
8%
fatigue
8%
tremor
6%
insomnia
4%
orthostatic hypotension
4%
nasopharyngitis
2%
ACUTE MYOCARDIAL INFARCTION
2%
headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
P2B001 Treatment A
P2B001 Treatment B
Placebo
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Senaparib (IMP4297) 20 mgExperimental Treatment1 Intervention
During the treatment period, eligible patients will receive single agent of Senaparib at a dose of 100 mg once daily (QD), continuously on a 4-week cycle
Group II: PlaceboPlacebo Group1 Intervention
During the treatment period, eligible patients will receive placebo QD, continuously on a 4-week cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
Impact Therapeutics, Inc.Lead Sponsor
14 Previous Clinical Trials
1,319 Total Patients Enrolled
2 Trials studying Prostate Cancer
96 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My organ functions are within normal ranges and I haven't had specific medical support in the last 14 days.I haven't taken strong drugs that affect liver enzymes within 21 days before starting the study drug.I have not received any live vaccines within the last 28 days.I am currently dealing with a serious infection.I will use a condom for 3 months after treatment, and my partner will use birth control.I have been treated with a PARP inhibitor before.I am starting or changing my bisphosphonate/denosumab treatment soon.I am willing and able to follow the study rules and work with the research team.I am a man aged 18 or older.I have had a bone marrow or double cord blood transplant.You are allergic to Senaparib or any of its ingredients.I am able to get out of my bed or chair and move around.I have MDS, AML, or symptoms suggesting these conditions.I am castrated with low testosterone levels and if on hormone therapy, will continue it during the study.My prostate cancer has been confirmed by a lab test.
Research Study Groups:
This trial has the following groups:- Group 1: Senaparib (IMP4297) 20 mg
- Group 2: Placebo
Awards:
This trial has 0 awards, including: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.
What adverse effects have been reported for taking Senaparib (IMP4297) 20 mg?
"Based on the data available, our team at Power has assigned Senaparib (IMP4297) 20 mg a score of 2. This is because Phase 2 clinical trials have yielded evidence that this drug may be safe for human use but there are no studies yet to prove efficacy."
Answered by AI
Is this research endeavor actively recruiting participants?
"According to clinicaltrials.gov, the recruiting period for this medical trial ended on December 14th 2021 after being posted at the end of the year (12/31/2021). However, 9 other studies are currently accepting candidates."
Answered by AI
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