PARP Inhibitor
NMS-03305293 for Solid Tumors
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milano, Italy
NMS-03305293Phase 1RecruitingLed by PierFranco Conte, MDResearch Sponsored by Nerviano Medical SciencesEligibility 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
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upfrom 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
No Placebo-Only Group
Study Summary
This trial is testing a new cancer drug to see if it is safe and works against different types of cancer.
Eligible Conditions
- Advanced/Metastatic Solid Tumors
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
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.
Select...
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 weeks3 visits
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.
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.
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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 site
Who is running the clinical trial?
Nerviano Medical SciencesLead Sponsor
12 Previous Clinical Trials
681 Total Patients Enrolled
PierFranco Conte, MDPrincipal Investigator
Istituto Oncologico Veneto IRCCS1 Previous Clinical Trials
524 Total Patients Enrolled
Valentina Guarneri, MDPrincipal Investigator
Istituto Oncologico Veneto IRCCSMedia Library
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