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Gynecologic NeoplasmsPhase 1/2NCT04493619

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

A Phase 1/2 study testing PLX2853 and Carboplatin in people with Gynecologic Neoplasms and Epithelial Ovarian Cancer, run by Opna Bio LLC at 9 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
PLX2853 and Carboplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
9 sitesin 2 countries
Study dates
11 Aug 2020to 25 Apr 2022
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years at the time of signing informed consent
  • Histologically or cytologically confirmed diagnosis of 1 of the following, and must have measurable disease per RECIST v1.1:
  • Phase 2a (PLX2853 monotherapy): Any advanced gynecological malignancy (cervical, vaginal, vulvar, uterine, ovarian, fallopian tube, or primary peritoneal) with a known ARID1A mutation, that is intolerant to or refractory 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).
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1
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  • Adequate organ function as demonstrated by laboratory values.
  • Women of child bearing potential (defined as any female who has experienced menarche and who has not undergone successful surgical sterilization or is not postmenopausal) 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 contraception (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.
  • 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 Common Terminology Criteria for Adverse Events version 5.0 [NCI CTCAE v5.0]) prior to study treatment administration (Grade 2: alopecia, hot flashes, decreased libido, or neuropathy is allowed).
  • Willingness and ability to provide written informed consent prior to any study-related procedures and to comply with all study requirements

Who cannot join

  • Prior exposure to a bromodomain inhibitor
  • Ongoing systemic infection requiring treatment with antibiotic, antiviral, or antifungal treatment
  • Autoimmune hemolytic anemia or autoimmune thrombocytopenia
  • Presence of symptomatic or uncontrolled central nervous system or leptomeningeal metastases
  • Red blood cell or platelet transfusion within 14 days of Screening blood draw
  • Known or suspected allergy to the investigational agent or any agent given in association with this study
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  • Use of biotin (i.e., Vitamin B7) or supplements containing biotin higher than the daily adequate intake of 30 μg (NIH-ODS 2020).
  • Use of strong inhibitors and inducers of CYP3A4 and 2C8
  • Clinically significant cardiac disease
  • 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
  • Non-healing wound, ulcer, or bone fracture
  • Infection with HIV-1 or HIV-2. Exception: subjects with well-controlled HIV (e.g., CD4 >350/mm3 and undetectable viral load) are eligible.
  • Current active liver disease from any cause, including hepatitis A (hepatitis A virus immunoglobulin M positive), hepatitis B (hepatitis B virus [HBV] surface antigen positive), or hepatitis C (hepatitis C virus [HCV] antibody positive, confirmed by HCV ribonucleic acid).
  • Active known second malignancy 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
  • Major surgery or significant traumatic injury within 28 days prior to Cycle 1 Day 1
  • Hospitalization for subacute bowel obstruction within 28 days prior to Cycle 1 Day 1
  • 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 metastases, before and during the study as long as these were started at least 28 days prior to treatment with study drug.
  • Subject is participating in any other therapeutic clinical study (observational or registry studies are allowed).
  • Subjects who are pregnant or breast-feeding
  • 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.

Trial locations and contacts

9 sites in 2 countries.

9 sites in 2 countries

United States8 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • University of Virginia Health Systems

    Charlottesville, Virginia, 22908

  • The University of Chicago Medical Center

    Chicago, Illinois, 05841

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031

  • Tennessee Oncology / Sarah Cannon

    Nashville, Tennessee, 37203

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • University of Oklahoma - Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

  • University of Washington / Seattle Cancer Care Alliance

    Seattle, Washington, 98109

Other trials in United States

Canada1 site

  • Princess Margaret Cancer Centre

    Toronto, Ontario

Other trials in Canada

About this study

Official title: A Multicenter, Open-Label, Parallel, Phase 2a Study of PLX2853 Monotherapy in Advanced Gynecological Malignancies With a Known ARID1A Mutation and Phase 1b/2a Study of PLX2853/Carboplatin Combination Therapy in Platinum-Resistant Epithelial Ovarian Cancer

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.

Being tested
PLX2853, Carboplatin
Keywords
PLX2853, Ovarian Cancer, ARID1A, Gynecological Malignancies, Carboplatin
Medical subject headings
Genital Neoplasms, Female, Carcinoma, Ovarian Epithelial, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PLX2853Drug

    PLX2853 tablets

  • CarboplatinDrug

    Carboplatin IV injection, 5 mg•min/mL

Study groups in NCT04493619
Study groupRoleWhat they receive
Phase 2a PLX2853 Monotherapy (80 mg)ExperimentalSubjects with ARID1A mutation-positive advanced gynecological malignancies
Receives: Drug: PLX2853
Phase 1b PLX2853 (40 mg) + Carboplatin Combination TherapyExperimentalSubjects with platinum-resistant EOC
Receives: Drug: PLX2853; Drug: Carboplatin
Phase 2a PLX2853 (80 mg) + Carboplatin Combination TherapyExperimentalSubjects with platinum-resistant EOC
Receives: Drug: PLX2853; Drug: Carboplatin
Phase 1b PLX2853 (80 mg) + Carboplatin Combination TherapyExperimentalSubjects with platinum-resistant EOC
Receives: Drug: PLX2853; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 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

    Measured: 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)

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2020
  2. Study start11 Aug 2020
  3. Primary completion25 Apr 2022
  4. Study completion25 Apr 2022

Why it stopped: study terminated due to business realignment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04493619
Sponsor's protocol ID
PLX124-03
Status last verified
Oct 2024
First submitted
23 Jul 2020
Last updated
4 Nov 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing PLX2853 and Carboplatin in people with Gynecologic Neoplasms and Epithelial Ovarian Cancer, run by Opna Bio LLC at 9 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04493619.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2024.

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