Study of NMS-03305293 in Adult Patients With Relapsed Ovarian Cancer

Part of paid clinical trials in Peoria, Illinois.

Sponsor
Nerviano Medical Sciences
Study ID
NCT06930755
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • NMS-03305293 — DRUG
    Route of administration: Oral
  • Topotecan — DRUG
    Route of administration: Intravenous

Study Details

This is a multicenter, open-label Phase Ia/b study on the safety and efficacy of the combination of NMS-03305293 and topotecan in patients with recurrent ovarian cancer, with dose-limiting toxicity (DLT) escalation. The aim of this study is to determine the safety and tolerability, as well as to evaluate the anti-tumor efficacy and pharmacokinetics of NMS-03305293 in combination with topotecan.

Key Dates

Start date
May 13, 2026
Status verified
May 2026
Primary completion
May 31, 2027
Completion
Sep 26, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: NMS-03305293 and Topotecan
    NMS-03305293 will be administered orally, twice daily, on a 1-7-day schedule, in repeated 4-week cycles (i.e., 28 days). Topotecan will be administered intravenously (IV), once weekly, on Days 1, 8, and 15, of Weeks 1-3, in repeated 4-week cycles (i.e., 28 days) at 4 mg/m\^2 with maximum dose of 4 mg.

Primary Outcome Measure

Number of Participants with Adverse Events (AEs) [ Time Frame: Screening (Day ≤28) up to 28-day follow-up after end of treatment (Approximately 6 months) ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
OSF Saint Francis Medical CenterPeoriaIllinois61637-
Washington University School of Medicine in St. LouisSt LouisMissouri63130-
Penn Medicine - Perelman Center for Advanced MedicinePhiladelphiaPennsylvania19104-
Tennessee OncologyNashvilleTennessee37203-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Peoria, IL

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
OSF Saint Francis Medical Center· Peoria, ILWashington University School of Medicine in St. Louis· St Louis, MOPenn Medicine - Perelman Center for Advanced Medicine· Philadelphia, PATennessee Oncology· Nashville, TNThe University of Texas MD Anderson Cancer Center· Houston, TX

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