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ACTIVE NOT RECRUITING
NCT07109414
PHASE2/PHASE3

Trial of NP-G2-044 (Prilukae) Combined With PLD for Treatment of Platinum-Resistant Ovarian Cancer (ULTIMUS-1)

Sponsor: Novita Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

The purpose of the study is to identify the optimal dose level of NP-G2-044 in combination with standard of care (SOC) pegylated liposomal doxorubicin (PLD), and to compare the efficacy and safety of NP-G2-044+PLD vs. PLD alone in participants with platinum-resistant ovarian cancer (PROC).

Official title: Randomized Phase 2/3 Trial of NP-G2-044 (Prilukae) Combined With PLD for Treatment of Platinum-Resistant Ovarian Cancer (ULTIMUS-1)

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

380

Start Date

2025-12-29

Completion Date

2029-10-24

Last Updated

2026-03-09

Healthy Volunteers

No

Interventions

DRUG

NP-G2-044

NP-G2-044 will be provided as a tablet via oral route of administration in the study.

DRUG

PLD

PLD will be provided as an infusion via intravenous route of administration in the study.

Locations (6)

HonorHealth Cancer Care

Phoenix, Arizona, United States

Trials365

Shreveport, Louisiana, United States

Optimum Clinical Research Group, LLC

Albuquerque, New Mexico, United States

University of Pennsylvania Health System, Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, United States

Utah Cancer Specialists

Salt Lake City, Utah, United States

University Of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States