A Phase 1 interventional study of NMS-03305293 in Advanced/Metastatic Solid Tumors, sponsored by Nerviano Medical Sciences. Terminated at 10 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Nerviano Medical Sciences · Phase 1, Interventional, and Treatment
Phase I, first-in-human, open-label, multicenter, dose-escalation and dose expansion study with the aim of exploring safety, tolerability and preliminary antitumor activity of NMS-03305293 (a PARP inhibitor) as single agent in adult patients with selected advanced/metastatic, relapsed/refractory solid tumors who have exhausted standard treatment options or for whom standard therapy is considered unsuitable.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 52 is close to the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Nerviano Medical Sciences is the lead sponsor of 15 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria for Dose Escalation and Dose Expansion Part:
Patients must have progressive disease defined by RECIST 1.1 following standard therapy or be unsuitable for standard therapy. For CRPC patients, disease progression at study entry is defined as one or more of the following three criteria (according to PCWG2):
Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study indications or procedures.
Inclusion Criteria specific for Dose Expansion Part:
Patients must have received the following previous treatment:
Exclusion Criteria:
Prior malignancy except for any of the following:
Patients with histologically confirmed diagnosis of locally advanced/metastatic HER2 negative breast cancer, epithelial ovarian cancer, castration-resistant prostate cancer (CRPC) or pancreatic cancer.
Drug: NMS-03305293
Patients with gBRCA mutation and epithelial ovarian cancer.
Drug: NMS-03305293
Patients with gBRCA mutation and HER2 negative breast cancer previously treated with a PARP inhibitor.
Drug: NMS-03305293
Patients with gBRCA mutation and HER2 negative breast cancer who have not received prior therapy with a PARP inhibitor.
Drug: NMS-03305293
Patients with gBRCA mutation and castration-resistant prostate cancer (CRPC).
Drug: NMS-03305293
Patients with gBRCA mutation and pancreatic cancer who have not received prior therapy with a PARP inhibitor.
Drug: NMS-03305293
All patients will receive NMS-03305293 administered orally on Days 1-21 (schedule A) or Days 1-28 (schedule B) in repeated 4-week cycles.
Number of Participants with first-cycle dose limiting toxicity
Time frame: Time interval between the date of the first dose administration in Cycle 1 (each cycle is 28 days) and the date of the first dose administration in Cycle 2 which is expected to be 28 days or up to 42 days in case of dose delay due to toxicity
Number of participants with Adverse Events (AEs)
Safety will be assessed by AEs, which includes clinically significant abnormalities identified during a medical test (e.g. laboratory tests, vital signs, electrocardiogram, etc.). A treatment-emergent AE is defined as an AE observed after starting administration of the study drug up to 28 days after last dose of study medication intake. AEs will be coded with Medical Dictionary for Regulatory Activities and graded according to The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Time frame: From the Informed Consent signature to 28 days after the last dose of study treatment administration.
Maximum concentration (Cmax) of NMS-03305293 after single and multiple doses of drug
Plasma samples will be collected and used for pharmacokinetics assessments.
Time frame: Full PK : Schedule A, QD and BID dosing: Cycle 1, 2; Schedule B, QD and BID dosing: Cycle 1, 2 and 3. Sparse PK: Schedule A: and Schedule B Cycle 1, 2, 3 (last cycle and at each cycle from cycle 1 onwards).Cycle lenght is 4 weeks.
Time to observed Cmax (Tmax) of NMS-033052293 after single and multiple doses of drug
Plasma samples will be collected and used for pharmacokinetics assessments.
Time frame: Full PK : Schedule A, QD and BID dosing: Cycle 1, 2; Schedule B, QD and BID dosing: Cycle 1, 2 and 3. Sparse PK: Schedule A: and Schedule B Cycle 1, 2, 3 (last cycle and at each cycle from cycle 1 onwards).Cycle lenght is 4 weeks.
Area under the concentration-time curve to the last of measurable concentration (AUClast) of NMS-033052293 after single and repeated dose of drug.
Plasma samples will be collected and used for pharmacokinetics assessments.
Time frame: Full PK : Schedule A, QD and BID dosing: Cycle 1, 2; Schedule B, QD and BID dosing: Cycle 1, 2 and 3. Sparse PK: Schedule A: and Schedule B Cycle 1, 2, 3 (last cycle and at each cycle from cycle 1 onwards).Cycle lenght is 4 weeks.
Terminal elimination half-life (t1/2) of NMS-033052293 after single and multiple doses of drug.
Plasma samples will be collected and used for pharmacokinetics assessments.
Time frame: Full PK : Schedule A, QD and BID dosing: Cycle 1, 2; Schedule B, QD and BID dosing: Cycle 1, 2 and 3. Sparse PK: Schedule A: and Schedule B Cycle 1, 2, 3 (last cycle and at each cycle from cycle 1 onwards).Cycle lenght is 4 weeks.
Area under the plasma concentration vs. time curve to infinity (AUCinf) of NMS-033052293 after multiple doses of drug.
Plasma samples will be collected and used for pharmacokinetics assessments.
Time frame: Full PK : Schedule A, QD and BID dosing: Cycle 1, 2; Schedule B, QD and BID dosing: Cycle 1, 2 and 3. Sparse PK: Schedule A: and Schedule B Cycle 1, 2, 3 (last cycle and at each cycle from cycle 1 onwards).Cycle lenght is 4 weeks.
Accumulation ratio (Rac) of NMS-033052293 after multiple doses of drug.
Plasma samples will be collected and used for pharmacokinetics assessments.
Time frame: Full PK : Schedule A, QD and BID dosing: Cycle 1, 2; Schedule B, QD and BID dosing: Cycle 1, 2 and 3. Sparse PK: Schedule A: and Schedule B Cycle 1, 2, 3 (last cycle and at each cycle from cycle 1 onwards).Cycle lenght is 4 weeks.
Oral plasma clearance (CL/F) of NMS-033052293 after multiple doses of drug.
Plasma samples will be collected and used for pharmacokinetics assessments.
Time frame: Full PK : Schedule A, QD and BID dosing: Cycle 1, 2; Schedule B, QD and BID dosing: Cycle 1, 2 and 3. Sparse PK: Schedule A: and Schedule B Cycle 1, 2, 3 (last cycle and at each cycle from cycle 1 onwards).Cycle lenght is 4 weeks.
Apparent volume of distribution (Vd/F) of NMS-033052293 after multiple doses of drug.
Plasma samples will be collected and used for pharmacokinetics assessments.
Time frame: Full PK : Schedule A, QD and BID dosing: Cycle 1, 2; Schedule B, QD and BID dosing: Cycle 1, 2 and 3. Sparse PK: Schedule A: and Schedule B Cycle 1, 2, 3 (last cycle and at each cycle from cycle 1 onwards).Cycle lenght is 4 weeks.
Renal clearance of NMS-033052293 after multiple doses of drug.
Samples of urine will be used for pharmacokinetics assessments. To be collected in all patients enrolled after the first DLT.
Time frame: Schedule A, QD and BID dosing: Cycle 1 (Day 1 and 21). ; Schedule B, QD and BID dosing: Cycle 1 (Day 1 and 28).Cycle lenght is 4 weeks.
Objective tumor response (OR)
Objective tumor response (OR) measured using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. For prostate cancer patients response will be evaluated by RECIST version 1.1/PCWG3 for patients with measurable disease and by Prostatic Specific Antigen (PSA) for all patients through PCWG3 criteria.
Time frame: At baseline, every even cycle (Day 28), at the end of treatment and at follow-up, every 8 weeks, till disease progression, an average 18 months.
Progression Free Survival (PFS)
Progression Free Survival (PFS) will be calculated from the date of treatment initiation to the date of first documentation of disease progression according to RECIST 1.1 or RECIST 1.1/PCWG3 for patient with CRPC, or death due to any cause, whichever comes first.
Time frame: From date of first dose of study drug up to the date of first documentation of disease progression or death due to any cause, whichever comes first, an average of 2 years.
Time To Progression (TTP)
Time to Progression (TTP) will be evaluated from the date of treatment initiation to the date of first documentation of disease progression according to RECIST 1.1 criteria or RECIST 1.1/PCWG3 for patient with CRPC, or death due to progression, whichever comes first.
Time frame: 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.
Time to PSA progression (for prostate cancer only)
Time to PSA Progression will be calculated from the date of treatment initiation to the date of first documentation of PSA progression according to PCWG3 criteria.
Time frame: From date of first dose of study drug up to the date of first documentation of PSA progression, an average of 1 year.
This study is terminated, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Nerviano Medical Sciences