ClinicalTrials.gg
TerminatedNCT04493619Updated Nov 4, 2024Results posted

PLX2853 as a Single Agent in Advanced Gynecological Malignancies and in Combination With Carboplatin in Platinum-Resistant Epithelial Ovarian Cancer

A Phase 1/2 interventional study of PLX2853 and Carboplatin in Gynecologic Neoplasms and Epithelial Ovarian Cancer, sponsored by Opna Bio LLC. Terminated at 9 sites in 2 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-04.

Primary conditionCarcinoma, Ovarian EpithelialRegistry: Genital Neoplasms, FemaleReclassifiedWhy we changed it
Registry
Genital Neoplasms, Female — the first condition term the registry derived for this study.
ClinicalTrials.gg
Carcinoma, Ovarian Epithelial
Why
  1. The study's listed conditions name Carcinoma, Ovarian Epithelial, a narrower term within Genital Neoplasms, Female.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Opna Bio LLC · Phase 1/2, Interventional, and Treatment

Why this study was terminated
study terminated due to business realignment

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Phase
Phase 1/2
Study type
Interventional
Enrollment
37
Allocation
Non-randomized
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 500 studies in Carcinoma, Ovarian Epithelial with a site in United States — 29 open to participants now, 50 under way, 8 of them phase 3. Carcinoma, Ovarian Epithelial · United States.

Enrollment
185th of 381
37 · median 35
Started
2020
with 8 others
Phase 1/2
51 of 500
3 open now
Registered
437th of 500
by date

Among the 500 studies in Carcinoma, Ovarian Epithelial with a site in United States, this one is the 185th largest by enrollment of the 381 interventional ones that give a count, is one of 9 that started in 2020, is one of 51 in phase 1/2, and was the 437th registered.

Carcinoma, Ovarian Epithelial

798 studies on the registry are indexed under Carcinoma, Ovarian Epithelial; 102 are open to participants now.

Browse Carcinoma, Ovarian Epithelial studies →

Open to participants now

29 of the 500 studies in Carcinoma, Ovarian Epithelial with a site in United States are open now. Recruiting first, the newest first:

24 more — sign in →

All 29 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 75 Carcinoma, Ovarian Epithelial studies recruiting now, 50 (67%) set no upper age limit and 12 (16%) stop at 75 or younger; 2 take children under 18; 4 take healthy volunteers.

This study: 18 Years and older · female · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 500 studies in Carcinoma, Ovarian Epithelial with a site in United States, or all of them as a file.
02

Study summary

The purpose of this research study is to evaluate safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of the investigational drug PLX2853 in Advanced Gynecological Malignancies with a Known ARID1A Mutation and PLX2853/Carboplatin Combination Therapy in Platinum-Resistant Epithelial Ovarian Cancer.

03

Conditions studied

  • Gynecologic Neoplasms
  • Epithelial Ovarian Cancer

Browse trials for

Keywords

  • PLX2853
  • Ovarian Cancer
  • ARID1A
  • Gynecological Malignancies
  • Carboplatin
04

In context

Carcinoma, Ovarian Epithelial Reclassified

798 studies on the registry are indexed under Carcinoma, Ovarian Epithelial; 102 are open to participants now.

This study's enrollment of 37 is below the median of 45 across 585 interventional studies indexed under Carcinoma, Ovarian Epithelial.

Browse Carcinoma, Ovarian Epithelial studies →

Lead sponsor

Opna Bio LLC is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Compared within Carcinoma, Ovarian Epithelial, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Genital Neoplasms, Female. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age ≥18 years at the time of signing
  2. or cytologically confirmed diagnosis of 1 of the following, and must have per v1.1:

    • Phase 2a (PLX2853 monotherapy): Any advanced gynecological (cervical, vaginal, vulvar, uterine, ovarian, fallopian tube, or primary peritoneal) with a known ARID1A mutation, that is intolerant to or to all standard therapy known to confer clinical benefit.
    • Phase 1b and Phase 2a (PLX2853 + carboplatin combination):

    Platinum-resistant EOC (including fallopian tube or primary peritoneal cancer).

  3. (ECOG) Performance Status 0 to 1
  4. Adequate organ function as demonstrated by laboratory values.
  5. Women of child bearing potential (defined as any female who has experienced menarche and who has not undergone successful surgical sterilization or is not ) must have a negative serum pregnancy test within 7 days prior to taking the first dose of study drug and, if sexually active, must agree to use a highly effective method of (a contraception method with a failure rate \<1% per year) and 1 additional barrier method from the time of the negative pregnancy test to 90 days after the last dose of study drug. Women of non-child bearing potential may be included if they are either surgically sterile or have been postmenopausal for ≥1 year.
  6. Except as specified above for organ function, all drug-related toxicity from previous cancer therapy must be resolved (to Grade ≤1 or baseline per National Cancer Institute version 5.0 [NCI CTCAE v5.0]) prior to study treatment administration (Grade 2: alopecia, hot flashes, decreased libido, or neuropathy is allowed).
  7. Willingness and ability to provide written informed consent prior to any study-related procedures and to comply with all study requirements

Exclusion criteria

Exclusion Criteria:

  1. Prior exposure to a bromodomain inhibitor
  2. Ongoing systemic infection requiring treatment with antibiotic, antiviral, or antifungal treatment
  3. hemolytic anemia or autoimmune thrombocytopenia
  4. Presence of symptomatic or uncontrolled central nervous system or
  5. Red blood cell or transfusion within 14 days of Screening blood draw
  6. Known or suspected allergy to the agent or any agent given in association with this study
  7. Use of biotin (i.e., Vitamin B7) or supplements containing biotin higher than the daily adequate intake of 30 μg (NIH-ODS 2020).
  8. Use of strong inhibitors and inducers of and 2C8
  9. cardiac disease
  10. Inability to take oral medication or significant nausea and vomiting, malabsorption, or significant small bowel resection that, in the opinion of the Investigator, would preclude adequate absorption
  11. Non-healing wound, ulcer, or bone fracture
  12. Infection with -1 or HIV-2. Exception: subjects with well-controlled HIV (e.g., >350/mm3 and undetectable viral load) are eligible.
  13. Current active liver disease from any cause, including hepatitis A (hepatitis A virus immunoglobulin M positive), (hepatitis B virus [HBV] surface antigen positive), or (hepatitis C virus [HCV] antibody positive, confirmed by HCV ribonucleic acid).
  14. Active known second with the exception of any of the following:

    • Adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or in situ cervical cancer
    • Adequately treated Stage I cancer from which the subject is currently in remission and has been in remission for ≥2 years
    • Any other cancer from which the subject has been disease-free for ≥3 years
  15. Major surgery or significant traumatic injury within 28 days prior to Cycle 1 Day 1
  16. Hospitalization for subacute bowel obstruction within 28 days prior to Cycle 1 Day 1
  17. Receipt of anti-cancer therapy prior to Cycle 1 Day 1:

    • Chemotherapy, radiation therapy, or small molecule anti-cancer therapy for the treatment of cancer within 14 days or 5 half-lives (whichever is shorter) of Cycle 1 Day 1
    • Immune therapy or other biologic therapy (e.g., monoclonal antibodies, antibody-drug conjugates) for the treatment of cancer within 21 days or 5 half-lives (whichever is shorter) of Cycle 1 Day 1 Subjects can receive a stable dose of bisphosphonates for bone , before and during the study as long as these were started at least 28 days prior to treatment with study drug.
  18. Subject is participating in any other therapeutic clinical study (observational or registry studies are allowed).
  19. Subjects who are pregnant or breast-feeding
  20. Presence of any other medical, psychological, familial, sociological, or geographic condition potentially hampering compliance with the study protocol or would interfere with the study endpoints or the subject's ability to participate.
Terms in these criteria, in plain language(21)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

CTCAE grade

The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.

1
Mild.
2
Moderate.
3
Severe.
4
Life-threatening.
5
Death due to the event.

“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Leptomeningeal disease

Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.

Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

CD4 count

The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

06

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
37 participants (actual)

Study arms

  • Experimental
    Phase 2a PLX2853 Monotherapy (80 mg)

    Subjects with ARID1A mutation-positive advanced gynecological malignancies

    Drug: PLX2853

  • Experimental
    Phase 1b PLX2853 (40 mg) + Carboplatin Combination Therapy

    Subjects with platinum-resistant EOC

    Drug: PLX2853 · Drug: Carboplatin

  • Experimental
    Phase 2a PLX2853 (80 mg) + Carboplatin Combination Therapy

    Subjects with platinum-resistant EOC

    Drug: PLX2853 · Drug: Carboplatin

  • Experimental
    Phase 1b PLX2853 (80 mg) + Carboplatin Combination Therapy

    Subjects with platinum-resistant EOC

    Drug: PLX2853 · Drug: Carboplatin

Interventions

07

What researchers measure

Primary outcomes

  1. Phase 2a (PLX2853 Monotherapy): Number of Participants With Overall Response Rate (ORR) as Measured by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

    Overall response rate as measured by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

    Time frame: From 8 weeks of treatment for only PLX2853 (Cycle 3 Day 1; 28 days per cycle) until completion of long term follow-up, an average of 6 months.

  2. Phase 1b (PLX2853 + Carboplatin Combination): Establish the Number of Participants Reaching MTD/RP2D for the Combination of PLX2853 and Carboplatin

    MTD is defined as the maximum tolerated dose, which is determined from dose-limiting toxicity. If DLTs are observed in 2 or more of 6 subjects (or ≥33% of the cohort) at a dose level, the dose at which this occurs will be considered intolerable and the MTD will have been exceeded. The MTD is the dose below the intolerable dose. RP2D is the recommended Phase 2 dose, which was determined to be 80 mg

    Time frame: From time of first dose of PLX2853 and carboplatin until 30 days of end of treatment an average of 6 months.

  3. Phase 2a (PLX2853 + Carboplatin Combination): Number of Participants Reaching ORR as Measured by RECIST v1.1

    Overall response rate as measured by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

    Time frame: From 8 weeks of treatment with PLX2853 and Carboplatin (Cycle 3 Day 1; 28 days per cycle) until completion of long term follow-up, an average of 6 months.

08

Results

Posted Nov 4, 2024
Limitations and caveats
This study was discontinued early due to a business decision by the sponsor. Only combined data were provided for the combo arm. No outcome measures were evaluated.

Participant flow

Participant flow — Overall Study
MilestonePhase 2aPhase 1b CombinationPhase 1bPhase 2a Combination
Started143713
Completed0000
Not completed143713
Withdrew: Death4334
Withdrew: Study discontinued early10048
Withdrew: Lost to follow-up0001

Outcome measures

PrimaryPhase 2a (PLX2853 Monotherapy): Number of Participants With Overall Response Rate (ORR) as Measured by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

Overall response rate as measured by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

Time frame:
From 8 weeks of treatment for only PLX2853 (Cycle 3 Day 1; 28 days per cycle) until completion of long term follow-up, an average of 6 months.

No measurements were reported for this outcome.

PrimaryPhase 1b (PLX2853 + Carboplatin Combination): Establish the Number of Participants Reaching MTD/RP2D for the Combination of PLX2853 and Carboplatin

MTD is defined as the maximum tolerated dose, which is determined from dose-limiting toxicity. If DLTs are observed in 2 or more of 6 subjects (or ≥33% of the cohort) at a dose level, the dose at which this occurs will be considered intolerable and the MTD will have been exceeded. The MTD is the dose below the intolerable dose. RP2D is the recommended Phase 2 dose, which was determined to be 80 mg

Time frame:
From time of first dose of PLX2853 and carboplatin until 30 days of end of treatment an average of 6 months.
Reported as:
Count of participants · Participants
Phase 1b (PLX2853 + Carboplatin Combination): Establish the Number of Participants Reaching MTD/RP2D for the Combination of PLX2853 and Carboplatin
ParticipantsPLX2853 Phase 2a MonotherapyPLX2853 + Carboplatin Phase 1b/2a Combination Therapy
Phase 1b (PLX2853 + Carboplatin Combination): Establish the Number of Participants Reaching MTD/RP2D for the Combination of PLX2853 and Carboplatin00
PrimaryPhase 2a (PLX2853 + Carboplatin Combination): Number of Participants Reaching ORR as Measured by RECIST v1.1

Overall response rate as measured by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

Time frame:
From 8 weeks of treatment with PLX2853 and Carboplatin (Cycle 3 Day 1; 28 days per cycle) until completion of long term follow-up, an average of 6 months.

No measurements were reported for this outcome.

Adverse events

Collected over Through 30 days after last dose of study drug, an average of 6 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
PLX2853 Phase 2a Monotherapy5/14 (35.7%)6/14 (42.9%)14/14 (100%)
PLX2853 + Carboplatin Phase 1b/2a Combination Therapy11/23 (47.8%)10/23 (43.5%)20/23 (87%)
Most frequent serious events
Showing 10 of 21
Most frequent serious events
EventPLX2853 Phase 2a MonotherapyPLX2853 + Carboplatin Phase 1b/2a Combination Therapy
anemiaBlood and lymphatic system disorders2/141/23
obstruction gastricGastrointestinal disorders2/141/23
dehydrationMetabolism and nutrition disorders0/142/23
sepsisInfections and infestations1/140/23
abdominal painGastrointestinal disorders1/140/23
thrombocytopeniaBlood and lymphatic system disorders1/140/23
hepatic hematomaHepatobiliary disorders1/140/23
fatigueGeneral disorders1/140/23
large intenstinal obstructionGastrointestinal disorders1/140/23
small intestinal obstructionGastrointestinal disorders1/141/23
Most frequent other events
Showing 10 of 60
Most frequent other events
EventPLX2853 Phase 2a MonotherapyPLX2853 + Carboplatin Phase 1b/2a Combination Therapy
NauseaGastrointestinal disorders11/1418/23
Platelet count decreasedInvestigations4/1416/23
FatigueGeneral disorders7/1413/23
VomitingGastrointestinal disorders6/1410/23
AnemiaBlood and lymphatic system disorders6/146/23
Abdominal painGastrointestinal disorders5/148/23
ConstipationGastrointestinal disorders1/147/23
Decreased appetiteMetabolism and nutrition disorders2/147/23
DiarrheaGastrointestinal disorders4/147/23
HyperglycemiaMetabolism and nutrition disorders4/144/23

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)PLX2853 Phase 2a MonotherapyPLX2853 (40 mg) + Carboplatin Phase 1bPLX2853 (80 mg) + Carboplatin Phase 1bPLX2853 + Carboplatin Phase 2a Combination TherapyTotal
<=18 years00000
Between 18 and 65 years1024925
>=65 years413412
Sex: Female, Male
Sex: Female, Male(Participants)PLX2853 Phase 2a MonotherapyPLX2853 (40 mg) + Carboplatin Phase 1bPLX2853 (80 mg) + Carboplatin Phase 1bPLX2853 + Carboplatin Phase 2a Combination TherapyTotal
Female14371337
Male00000
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)PLX2853 Phase 2a MonotherapyPLX2853 (40 mg) + Carboplatin Phase 1bPLX2853 (80 mg) + Carboplatin Phase 1bPLX2853 + Carboplatin Phase 2a Combination TherapyTotal
Hispanic or Latino3001114
Not Hispanic or Latino935017
Unknown or Not Reported20226
Race (NIH/OMB)
Race (NIH/OMB)(Participants)PLX2853 Phase 2a MonotherapyPLX2853 (40 mg) + Carboplatin Phase 1bPLX2853 (80 mg) + Carboplatin Phase 1bPLX2853 + Carboplatin Phase 2a Combination TherapyTotal
American Indian or Alaska Native00000
Asian00123
Native Hawaiian or Other Pacific Islander00000
Black or African American02204
White11141127
More than one race00000
Unknown or Not Reported30003
Region of Enrollment
Region of Enrollment(participants)PLX2853 Phase 2a MonotherapyPLX2853 (40 mg) + Carboplatin Phase 1bPLX2853 (80 mg) + Carboplatin Phase 1bPLX2853 + Carboplatin Phase 2a Combination TherapyTotal
Canada00033
United States14071034
09

Study locations

9 sites
  • The University of Chicago Medical Center
    Chicago, Illinois 05841, United States
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10065, United States
  • University of Oklahoma - Stephenson Cancer Center
    Oklahoma City, Oklahoma 73104, United States
  • Tennessee Oncology / Sarah Cannon
    Nashville, Tennessee 37203, United States
  • University of Virginia Health Systems
    Charlottesville, Virginia 22908, United States
  • Virginia Cancer Specialists, PC
    Fairfax, Virginia 22031, United States
  • University of Washington / Seattle Cancer Care Alliance
    Seattle, Washington 98109, United States
  • Princess Margaret Cancer Centre
    Toronto, Ontario, Canada
10

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

11

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2020 to primary completion in Apr 2022, 20 months.

Results were first posted in Nov 2024, 2 years 6 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 23, 2020
First posted
Jul 30, 2020
StartActual
Aug 11, 2020
Primary completionActual
Apr 25, 2022
CompletionActual
Apr 25, 2022
Results first posted
Nov 4, 2024
Last update
Nov 4, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
12

Registry details

Key details

Study ID
NCT04493619
Lead sponsor
Opna Bio LLC
Responsible party
Sponsor
First posted
Jul 30, 2020
Start date
Aug 11, 2020
Primary completion
Apr 25, 2022
Completion
Apr 25, 2022
Results posted
Nov 4, 2024
Last update
Nov 4, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drug tested here: Zavabresib

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