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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT03297424

NCT03297424
Completed Phase 1

Who may be able to join

Who might be able to join this trial:

  • You have been diagnosed with an advanced solid tumor cancer (confirmed by tissue testing) that has not responded to previous treatments, or you have a type of blood cancer called non-Hodgkin's lymphoma (specifically diffuse large B-cell lymphoma or follicular lymphoma Grade 1–3A) that has come back or stopped responding after at least one prior treatment.
  • You are 18 years of age or older.
  • You are generally able to carry out daily activities with little or no limitation (your doctor can assess this using a standard scale called ECOG 0–1).
  • Your heart, liver, kidneys, and other organs are functioning well enough, based on blood tests done within 10 days of starting treatment.
  • If you are a woman who could become pregnant, you must have a negative pregnancy test within 7 days before starting the study drug, and you must agree to use effective birth control from that point until 90 days after your last dose.
  • If you are a woman who cannot become pregnant — either because you have had a surgical procedure or have been through menopause for at least 1 year — you may also be eligible.
  • If you are a man who is able to father children, you must agree to use effective birth control during the study and for up to 90 days after your last dose.
  • Any significant side effects from your previous cancer treatments must have cleared up before you can start this study (some exceptions, such as hair loss or mild nerve-related symptoms, are allowed).
  • You are willing and able to sign a consent form and follow all study requirements.

Who may not be able to join:

  • You have previously taken a type of drug called a bromodomain inhibitor (for example, OTX-015 or CPI-0610).
  • You have an active, uncontrolled infection (fungal, bacterial, or viral) that is moderate or severe in nature.
  • You have a condition where your immune system is attacking your own red blood cells or platelets.
  • You have cancer that has spread to your brain or the lining around your brain and spinal cord, and it is causing symptoms or is not under control.
  • You have a known or suspected allergy to the study drug or any other drug used in this trial.
  • You have significant heart problems, such as an uncontrolled irregular heartbeat, uncontrolled high blood pressure, or a history of blood clots in your veins or arteries (people with well-controlled atrial fibrillation may still be eligible — confirm with trial site).
  • You are unable to swallow pills, or you have a digestive condition that would prevent you from properly absorbing the study drug (such as severe nausea, a malabsorption condition, or major bowel surgery).
  • You have a wound, ulcer, or bone fracture that is not healing.
  • You are known to have HIV, active hepatitis B, or hepatitis C infection (some people with past hepatitis B exposure may still be eligible if certain blood test results are undetectable — confirm with trial site).
  • You currently have another active cancer, with some exceptions such as certain treated skin cancers, early-stage cancers in remission for 2 or more years, low-risk prostate cancer meeting specific criteria, or any cancer from which you have been cancer-free for 3 or more years.
  • You have liver metastases (cancer spread to the liver) covering more than half of the liver, or any single liver tumor larger than 5 cm.
  • You have had major surgery or a serious injury within 14 days before starting the study.
  • You have received chemotherapy, radiation, or certain targeted cancer drugs too recently before starting the study (specific waiting periods apply depending on the type of treatment — confirm with trial site).
  • You are currently taking steroids at a dose higher than the equivalent of 10 mg of prednisone per day on a regular basis (short-term use for nausea is an exception).
  • You are currently taking part in another clinical trial that involves an active treatment.
  • You are pregnant or currently breastfeeding.
  • You have any other medical, personal, or life circumstance that, in your doctor's judgment, might make it difficult to safely participate in or complete the study.

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 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.

Trial details

Status
Completed
Phase
Phase 1
Sponsor
Opna Bio LLC
Registry
clinicaltrials_gov
Start date
12 September 2017
Est. completion
7 June 2021

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.; Area under the concentration-time curve (AUC) of PLX2853.; Maximum observed concentration (Cmax) of PLX2853.; Time to peak concentration (Tmax) of PLX2853.; Half life (t1/2) of PLX2853.; Number of participants who experience dose limiting toxicity as defined in the protocol.; Change in disease burden using RECIST 1.1 (solid tumors) or Lugano criteria (NHL).

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