Back to Ovarian Cancer

NCT07109414

NCT07109414
Active, Not Recruiting Phase 3

Who may be able to join

Who might be able to join this trial:

  • You have been diagnosed with a specific type of ovarian cancer called high-grade serous carcinoma, confirmed by a lab test
  • Your cancer has stopped responding to platinum-based chemotherapy (known as platinum resistance)
  • You have not received a chemotherapy drug called PLD (pegylated liposomal doxorubicin) after your cancer became resistant to platinum treatment
  • You have previously been treated with a drug called bevacizumab, or your doctor determined you were not suitable for it
  • You are generally well enough to carry out light activity and care for yourself (a fitness score of 0 or 1 on a standard medical scale)
  • Your cancer can be measured on a scan
  • Your heart is pumping well enough (the lower chamber of your heart is working at more than 50% capacity)
  • Your blood counts, liver, kidneys, and other body functions are within acceptable ranges based on blood tests (confirm with trial site for specific values)
  • If you could become pregnant, you must have a negative pregnancy test within 3 days before starting treatment and agree to use reliable contraception or avoid sexual activity for the duration of the study and for 120 days after your last dose

Who may not be able to join:

  • Your cancer did not respond to platinum-based chemotherapy at all from the very beginning, or came back within 120 days of finishing your first course of platinum treatment
  • Your cancer came back more than 183 days after your most recent platinum treatment (meaning it is considered platinum-sensitive rather than platinum-resistant)
  • You have uncontrolled fluid build-up around your lungs or in your abdomen that required draining within the last 60 days
  • You have had a major operation within the 4 weeks before joining the study
  • You have had radiotherapy within 4 weeks before starting the study, or you have not fully recovered from radiation side effects, or you have a history of radiation-related lung damage
  • You are currently receiving or have recently received any other cancer treatment, such as chemotherapy, immunotherapy, hormone therapy, targeted therapy, or another clinical trial drug
  • Your cancer has spread to the brain and is currently active, or it has spread to the lining around the brain or spinal cord
  • You have a cancer that started in the brain
  • You have serious bowel problems such as a blockage, are unable to tolerate food by mouth, use a tube through your nose to drain your stomach, or are vomiting more than once a day
  • More than 60% of your liver is affected by cancer spread
  • You have a known active infection with HIV, Hepatitis B, or Hepatitis C
  • You are currently taking medication that suppresses your immune system
  • You have an active bacterial, fungal, or viral infection at the time of screening
  • You have received a live vaccine within 6 weeks before your first dose of the study drug
  • You have received a COVID-19 vaccine less than 1 week before starting the study, or less than 3 weeks before a scheduled tumour scan during the study
  • Your heart's electrical activity shows a specific abnormality (QTcF interval greater than 470 ms) on an ECG (confirm with trial site)
  • You are pregnant or breastfeeding
  • You currently have another active cancer
  • You have a history of a lung condition called interstitial lung disease, including cases caused by drugs or radiation that needed steroid treatment
  • You have had a stroke, unstable chest pain (angina), heart attack, serious heart failure, significant heart muscle thickening, or a heart rhythm problem requiring medication or a device within the last 6 months
  • You have certain heart rhythm risk factors, including abnormal levels of potassium, magnesium, or calcium in your blood, a hereditary heart condition called long QT syndrome, or a very slow heart rate (fewer than 50 beats per minute)
  • You have an unstable or serious uncontrolled medical condition, such as heart or lung problems, uncontrolled diabetes, or other significant illness
  • You previously had a severe (grade 3 or 4) reaction to PLD chemotherapy
  • You currently have moderate or severe nerve damage causing symptoms such as numbness, tingling, or weakness (grade 2 or higher neuropathy)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Active, Not Recruiting
Phase
Phase 3
Sponsor
Novita Pharmaceuticals, Inc.
Registry
clinicaltrials_gov
Start date
29 December 2025
Est. completion
25 October 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Part A (Dose escalation): Number of participants with adverse events (AEs); Part A (Dose escalation): Number of participants with Dose Limiting Toxicities (DLTs); Part B (Dose Optimization): Number of participants with AEs; Part B (Dose Optimization): Overall response rate (ORR); Part B (Dose Optimization): Progression free survival (PFS); Part C (Phase 3): Progression free survival (PFS)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov