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PARP Inhibitor

NMS-03305293 for Solid Tumors

Phase 1
Waitlist Available
Led By PierFranco Conte, MD
Research Sponsored by Nerviano Medical Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with histologically confirmed diagnosis of locally advanced/metastatic HER2 negative breast cancer, epithelial ovarian cancer, castration-resistant prostate cancer (CRPC) or pancreatic cancer. BRCA1 and BRCA2 mutation status is not required for enrollment in the Dose Escalation part, but enrichment with deleterious/pathogenic or likely pathogenic/suspected deleterious BRCA carriers will be attempted.
- HER2 negative breast cancer: no more than 3 prior chemotherapy regimens for locally advanced and/or metastatic disease (no limit on prior hormonal therapies or targeted anticancer therapies). At least 1 line of taxane or anthracycline based chemotherapy, if not contraindicated, in adjuvant/neoadjuvant or metastatic setting. If HR (Hormone Receptor) positive, at least 1 line of prior endocrine therapy. Prior treatment with PARP inhibitors is required in the HER2 neg breast cancer cohort pre-treated with a PARP inhibitor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of first dose of study drug up to the date of first documentation of disease progression or death due to progression, an average of 2 years.
Awards & highlights

Study Summary

This trial is testing a new cancer drug to see if it is safe and works against different types of cancer.

Who is the study for?
Adults with certain advanced or metastatic solid tumors who have tried all standard treatments or can't receive them. They must be able to swallow capsules, have a life expectancy of at least 3 months, and an ECOG performance status ≤2. Participants need measurable disease by RECIST criteria, except for CRPC patients who may have non-measurable disease.Check my eligibility
What is being tested?
The trial is testing NMS-03305293 (a PARP inhibitor) as a single agent in phase I to see how safe it is and if it works against specific relapsed/refractory solid tumors. It's the first time this drug is being given to humans, starting with low doses that increase until they find the best dose without severe side effects.See study design
What are the potential side effects?
As this is a first-in-human study for NMS-03305293, potential side effects are not yet fully known but may include typical reactions seen with other PARP inhibitors such as nausea, fatigue, blood cell count changes leading to increased infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have been diagnosed with advanced/metastatic breast cancer, ovarian cancer, castration-resistant prostate cancer, or pancreatic cancer. The presence of specific gene mutations (BRCA1 and BRCA2) is not necessary for participation, but we will try to include those who have these mutations.
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If you have HER2 negative breast cancer, you should have received no more than 3 chemotherapy treatments for advanced or spreading cancer. There is no limit on previous hormonal or targeted therapies. You should have received at least one treatment with taxane or anthracycline chemotherapy, unless it was not recommended for you. If your cancer is hormone receptor positive, you should have received at least one treatment with hormonal therapy. If you were treated with a PARP inhibitor before, it is required for you to participate in the study for HER2 negative breast cancer.
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You are expected to live for at least 3 more months.
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You can swallow the study medication capsules without breaking them open or chewing them.
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You must have already tried certain treatments before joining the study.
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You have had up to 4 previous treatments for advanced or spreading ovarian cancer, including at least one treatment involving platinum-based chemotherapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of first dose of study drug up to the date of first documentation of disease progression or death due to progression, an average of 2 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of first dose of study drug up to the date of first documentation of disease progression or death due to progression, an average of 2 years. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with first-cycle dose limiting toxicity
Secondary outcome measures
Accumulation ratio (Rac) of NMS-033052293 after multiple doses of drug.
Apparent volume of distribution (Vd/F) of NMS-033052293 after multiple doses of drug.
Area under the concentration-time curve to the last of measurable concentration (AUClast) of NMS-033052293 after single and repeated dose of drug.
+11 more

Trial Design

6Treatment groups
Experimental Treatment
Group I: Dose Expansion Part - Pretreated HER 2 Neg. Breast CancerExperimental Treatment1 Intervention
Patients with gBRCA mutation and HER2 negative breast cancer previously treated with a PARP inhibitor.
Group II: Dose Expansion Part - Pancreatic CancerExperimental Treatment1 Intervention
Patients with gBRCA mutation and pancreatic cancer who have not received prior therapy with a PARP inhibitor.
Group III: Dose Expansion Part - No Pretreated HER 2 Neg. Breast CancerExperimental Treatment1 Intervention
Patients with gBRCA mutation and HER2 negative breast cancer who have not received prior therapy with a PARP inhibitor.
Group IV: Dose Expansion Part - Epithelial Ovarian CancerExperimental Treatment1 Intervention
Patients with gBRCA mutation and epithelial ovarian cancer.
Group V: Dose Expansion Part - CRPCExperimental Treatment1 Intervention
Patients with gBRCA mutation and castration-resistant prostate cancer (CRPC).
Group VI: Dose Escalation PartExperimental Treatment1 Intervention
Patients with histologically confirmed diagnosis of locally advanced/metastatic HER2 negative breast cancer, epithelial ovarian cancer, castration-resistant prostate cancer (CRPC) or pancreatic cancer.

Find a Location

Who is running the clinical trial?

Nerviano Medical SciencesLead Sponsor
12 Previous Clinical Trials
790 Total Patients Enrolled
PierFranco Conte, MDPrincipal InvestigatorIstituto Oncologico Veneto IRCCS
1 Previous Clinical Trials
524 Total Patients Enrolled
Valentina Guarneri, MDPrincipal InvestigatorIstituto Oncologico Veneto IRCCS

Media Library

NMS-03305293 (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04182516 — Phase 1
Solid Tumors Research Study Groups: Dose Expansion Part - Epithelial Ovarian Cancer, Dose Expansion Part - Pretreated HER 2 Neg. Breast Cancer, Dose Expansion Part - CRPC, Dose Expansion Part - Pancreatic Cancer, Dose Escalation Part, Dose Expansion Part - No Pretreated HER 2 Neg. Breast Cancer
Solid Tumors Clinical Trial 2023: NMS-03305293 Highlights & Side Effects. Trial Name: NCT04182516 — Phase 1
NMS-03305293 (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04182516 — Phase 1

Frequently Asked Questions

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

How many individuals are partaking in this empirical research?

"Affirmative, according to clinicaltrials.gov this research endeavour is actively searching for subjects. It was first posted on November 25th 2019 and recently amended on March 14th 2022. The study's objective is to include 150 patients from one location into the trial."

Answered by AI

Has NMS-03305293 achieved the green light from the FDA?

"Our team at Power assigned a value of 1 to the safety rating for NMS-03305293, as this is an early clinical trial and there is limited data about its efficacy."

Answered by AI

Could patients join the experiment at this time?

"Confirmed. According to information published on clinicaltrials.gov, this trial is presently seeking participants who meet eligibility criteria. The trial was initially listed on November 25th 2019 and has been amended as recently as March 14th 2022. This medical study seeks 150 patients from one location for enrolment into the program."

Answered by AI
~28 spots leftby Mar 2025