Phase 1 Ovarian Cancer Trial, Recruiting NCT05636111 Sponsor: M.D. Anderson Cancer Center Condition: Ovarian Cancer
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Phase 1 Ovarian Cancer Trial, Recruiting

NCT05636111
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 18 or older at the time of joining the study.
  • People who are willing and able to follow the study schedule, including attending appointments and completing follow-up visits, for the full duration of the trial.
  • People who have been diagnosed (confirmed by laboratory tissue testing) with ovarian cancer, fallopian tube cancer, or peritoneal carcinoma (cancer affecting the lining of the abdomen).
  • People whose cancer has stopped responding to platinum-based chemotherapy, either during treatment or within 6 months after finishing it.
  • People who have previously received anti-blood-vessel-targeting therapies (such as bevacizumab) are still eligible to be considered.
  • People who have received any number of prior cancer treatments before this trial.
  • People who are generally well enough to carry out light activity and care for themselves (based on a standard fitness scale used by doctors, rated 0 or 1 out of 5).
  • People whose blood counts, liver function, and kidney function meet the minimum levels set by the trial (confirmed through blood tests).
  • People who either have confirmed post-menopausal status or have a negative pregnancy test before starting treatment. People of childbearing potential must agree to use two forms of contraception during the study and for three months after the last dose.
  • People whose cancer can be measured on scans using standard criteria (known as RECIST v1.1).

Who may not be able to join:

  • People who have received radiation, chemotherapy, immunotherapy, or any other cancer treatment within 2 weeks before the study start date.
  • People who have used an anti-cancer or experimental drug within 28 days (or 5 half-lives of that drug, whichever is shorter) before the study start date, with at least 10 days required between stopping prior treatment and starting the study.
  • People with known or suspected bowel conditions that could increase the risk of digestive side effects, such as inflammatory bowel disease, bowel obstruction, a history of bowel obstruction, or cancer directly affecting the bowel.
  • People who are currently pregnant or breastfeeding.
  • People who have had major surgery within 28 days before the study start date.
  • People with unstable heart function, including certain abnormal heart rhythms requiring treatment, significant heart failure, or a heart attack within the past 3 months.
  • People with an active, uncontrolled infection currently requiring intravenous antibiotics, antivirals, or antifungal medicines within one week before the first dose (people with controlled infections or taking preventive antibiotics may still be considered).
  • People with a known history of hepatitis A, B, or C, active hepatitis B or C infection detected by blood tests, or a positive HIV test.
  • People with significant nerve damage in their hands or feet rated above a moderate level (Grade 2) at the time of screening.
  • People with serious psychiatric or medical conditions that could interfere with completing treatment.
  • People who have participated in another experimental cancer treatment study within 3 weeks before the study start date.
  • People currently receiving any other approved or experimental cancer treatment (steroids are an exception).
  • People with active bleeding problems or blood clotting issues, including peptic ulcer bleeding, nosebleeds, or spontaneous bleeding within 4 weeks before the study start date.
  • People with brain tumour deposits that are causing symptoms.
  • People with significant problems with blood clotting that are not related to a prescribed blood-thinning medication.
  • People who have coughed up notable amounts of blood within 1 month before joining the study.
  • People with wounds, ulcers, or bone fractures that are not healing.
  • People with a known allergic reaction to any of the study drugs: lurbinectedin, paclitaxel, or bevacizumab, or to any of their ingredients.

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 21 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Shannon Westin, MD, M.D. Anderson Cancer Center

Phone: 713-794-4314

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Registry
ClinicalTrials.gov
Start date
12 July 2023
Est. completion
31 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

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: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov