Study on NP-G2-044 (Prilukae) Combined with PLD for Treating Platinum-Resistant Ovarian Cancer (ULTIMUS-1)
Sponsor: Novita Pharmaceuticals, Inc.
ClinicalTrials ID:NCT07109414
This clinical trial is testing a new treatment combining NP-G2-044 with a standard chemotherapy drug, PLD, to see if it works better than PLD alone in women with ovarian cancer that doesn't respond to platinum-based treatments.
Patient Parameters
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Program Overview
The study aims to find the best dose of NP-G2-044 when used with PLD, a standard chemotherapy drug, and to compare how well this combination works against using PLD alone in women with platinum-resistant ovarian cancer. The trial will involve women aged 18 and older with confirmed high-grade serous ovarian cancer that has not responded to platinum-based therapy.
Description
This study is open-label, meaning both the researchers and participants know what treatment is being given. It is divided into two phases: Phase 2 and Phase 3. In Phase 2, the study will start with testing different doses of NP-G2-044 alone and then in combination with PLD to find the safest and most effective dose. After that, the study will compare the combination of NP-G2-044 and PLD with PLD alone. In Phase 3, participants will be randomly assigned to receive either the combination treatment or PLD alone, based on the best dose found in Phase 2. Participants will be grouped based on the number of previous treatments they have had, the number of times they have received PLD, and their location in the world. The study is for women with high-grade serous ovarian cancer that is resistant to platinum-based treatments, who are in good general health and have not used PLD after becoming resistant to platinum treatments.
Eligibility Criteria
Inclusion Criteria
- Women with confirmed high-grade serous ovarian cancer.
- Cancer must be resistant to platinum-based treatments.
- No use of PLD after developing resistance to platinum treatments.
- Must have received bevacizumab in a previous treatment or be ineligible for it.
- Good general health with an ECOG status of 0-1.
- Cancer that can be measured by scans.
- Heart function with an ejection fraction over 50%.
- Adequate blood cell counts and liver and kidney function.
- Women of childbearing potential must have a negative pregnancy test and use effective contraception during the study and for 120 days after the last dose.
Exclusion Criteria
- Cancer that did not respond to the first platinum treatment or returned more than 183 days after the last platinum treatment.
- Uncontrolled fluid buildup in the chest or abdomen.
- Major surgery or radiation therapy within the last 4 weeks.
- Active cancer spread to the brain or spinal cord.
- Severe digestive issues or liver metastases involving more than 60% of the liver.
- Active infections like HIV, Hepatitis B, or C.
- Need for immunosuppressive therapy or recent live vaccines.
- Heart issues or other severe medical conditions.
- Pregnant or breastfeeding women.
- Other active cancers or severe lung diseases.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| HonorHealth Cancer Care - Biltmore | 85016 | Phoenix | Arizona |
| Trials365 | 71133 | Shreveport | Louisiana |
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