What side effects are associated with this type of intervention?

PARP inhibitors like Senaparib, used in prostate cancer treatment, commonly cause side effects such as anemia, nausea, fatigue, and thrombocytopenia. Other treatments for prostate cancer, such as androgen receptor inhibitors (e.g., enzalutamide, apalutamide) can cause fatigue, hypertension, and seizures. Chemotherapy agents like docetaxel may lead to neutropenia, febrile neutropenia, and gastrointestinal symptoms. These side effects are generally manageable with supportive care and dose adjustments.

What prior FDA approvals exist?

Several PARP inhibitors have been approved by the FDA for the treatment of prostate cancer, particularly for patients with specific genetic mutations. Rucaparib and Olaparib are two such drugs that have received FDA approval for use in metastatic castration-resistant prostate cancer (mCRPC) with homologous recombination repair (HRR) gene alterations, such as BRCA1/2 mutations. These approvals are based on clinical trials demonstrating their efficacy in improving progression-free survival and overall response rates in patients who have previously undergone treatments like docetaxel and androgen receptor-targeted therapies.

What other types of research exist?

Promising alternatives to Senaparib for prostate cancer patients include Olaparib and Niraparib, both of which have shown efficacy in patients with homologous recombination repair (HRR) gene alterations. Additionally, the combination of Olaparib with abiraterone has demonstrated significant prolongation in radiographic progression-free survival. Immunotherapy options such as Pembrolizumab for patients with dMMR or high TMB tumors, and the combination of Durvalumab and Olaparib for those with high neoantigen load, are also emerging as potential treatments.

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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.

Must not have

Patients who have received strong inhibitors/inducers of CYP3A4 which cannot be discontinued 21 days prior to the first dose of study drug and withheld throughout the study drug treatment. Patients received phenobarbital/enzalutamide will require a 5-week washout prior to the first dose of study drug.

Patients with serious acute or chronic infections.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 80 weeks

Summary

This trial is testing Senaparib, a medication, in patients with advanced prostate cancer who have specific genetic changes and have not responded to previous treatment. Senaparib works by blocking proteins that help cancer cells repair their DNA, which may cause the cancer cells to die. The study aims to see if Senaparib is effective and safe for these patients.

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't taken strong drugs that affect liver enzymes within 21 days before starting the study drug.

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I am currently dealing with a serious infection.

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I have been treated with a PARP inhibitor before.

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I have had a bone marrow or double cord blood transplant.

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I have MDS, AML, or symptoms suggesting these conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 80 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~80 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 80 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Cmax

Objective response rate (ORR) according to RECIST v1.1 assessed by BICR

+9 more

Side effects data

From 2015 Phase 2 & 3 trial • 149 Patients • NCT01968460

20%

NAUSEA

16%

SOMNOLENCE

10%

DIZZINESS

fatigue

tremor

insomnia

orthostatic hypotension

nasopharyngitis

ACUTE MYOCARDIAL INFARCTION

headache

100%

80%

60%

40%

20%

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

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Prostate cancer treatments often target the androgen receptor signaling pathway, which is crucial for prostate cancer cell growth. Androgen receptor inhibitors like enzalutamide and abiraterone block the effects of androgens, slowing cancer progression. Chemotherapy agents such as docetaxel disrupt cell division, leading to cancer cell death. PARP inhibitors, including Senaparib, target cancer cells with homologous recombination repair (HRR) deficiencies by preventing DNA repair, causing cell death. These mechanisms are vital as they offer targeted approaches to manage and potentially improve outcomes for prostate cancer patients, especially those with specific genetic alterations.