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Small Cell Lung CancerPhase 1NCT03297424

A Study of PLX2853 in Advanced Malignancies.

A Phase 1 study testing PLX2853 in people with Small Cell Lung Cancer and Uveal Melanoma, run by Opna Bio LLC at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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 subjects with advanced malignancies. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PLX2853
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
5 sitesUnited States
Study dates
12 Sep 2017to 7 Jun 2021
Phase
Phase 1
Are there results?
None posted in the registry

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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Confirmed diagnosis of one of the following:
  • Phase 1b:
  • Histologically confirmed advanced refractory solid tumor that is measurable or evaluable per RECIST 1.1 criteria.
  • Histologically confirmed NHL: diffuse large B-cell lymphoma and follicular lymphoma (Grade 1-3A) which is measurable or evaluable per Lugano criteria, has progressed following at least 1 line of prior anticancer therapy.
  • Phase 2a: Patients with various solid tumors or NHL who have received prior therapy.
  • Age ≥18 years
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  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
  • Adequate organ function as appropriate for the disease under study. All screening laboratory tests should be performed within 10 days of treatment initiation.
  • Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test at Screening (≤7 days prior to 1st study drug dose) and must agree to use an effective form of contraception from the time of the negative pregnancy test up to 90 days after the last dose of study drug. Effective forms of contraception include abstinence, hormonal contraceptive in conjunction with a barrier method, or a double barrier method. Women of non-child-bearing potential may be included if they are either surgically sterile or have been postmenopausal for ≥1 year.
  • Fertile men must agree to use an effective method of birth control during the study and for up to 90 days after the last dose of study drug.
  • All associated clinically significant drug-related toxicity from previous cancer therapy must be resolved prior to study treatment administration (alopecia, erectile impotence, hot flashes, decreased libido, and 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, such as OTX-015 or CPI-0610
  • Known uncontrolled fungal, bacterial, and/or viral infection ≥Grade 2
  • Autoimmune hemolytic anemia or autoimmune thrombocytopenia
  • Presence of symptomatic or uncontrolled central nervous system or leptomeningeal metastases
  • Known or suspected allergy to the investigational agent or any agent given in association with this trial
  • Clinically significant cardiac disease such as cardiac arrhythmias including bradyarrhythmias and/or subjects who require anti-arrhythmic therapy (excluding beta blockers or digoxin), including uncontrolled hypertension or arterial or venous thrombotic events. Subjects with controlled atrial fibrillation are not excluded.
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  • 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
  • Subject has known human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection or is known to be a carrier of hepatitis B or C. Subjects who are positive for hepatitis C virus (HCV) antibody must be negative for HCV by polymerase chain reaction (PCR) to be eligible. Subjects with occult or prior hepatitis B virus (HBV) infection (defined as positive total hepatitis B core antibody (HBcAb) and negative hepatitis B surface antigen (HBsAg) may be included if HBV DNA is undetectable. These subjects must be willing to undergo additional testing per local standard of care.
  • Active 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;
  • Low-risk prostate cancer with Gleason score <7 and prostate-specific antigen <10 ng/mL; or
  • Any other cancer from which the patient has been disease-free for ≥3 years.
  • Subjects with documented hepatic metastases involving >50% of the hepatic parenchyma, or any individual liver metastasis >5 cm, as assessed by the investigator.
  • Major surgery or significant traumatic injury within 14 days prior to Cycle 1 Day 1
  • Receipt of anti-cancer therapy with insufficient washout prior to Cycle 1 Day 1: No chemotherapy, radiation therapy, or small molecule tyrosine kinase inhibitors (TKI) for the treatment of cancer within 14 days or 5 half-lives (whichever is shorter) of Cycle 1 Day 1. Certain standard of care hormonal anticancer therapies, such as agents targeted to GnRH for the treatment of prostate cancer or aromatase inhibitors for the treatment of breast cancer, may be permitted after consultation with the medical monitor. No immune therapy or other biologic therapy (other monoclonal antibodies or antibody-drug conjugates [ADCs]) for the treatment of cancer within 28 days of Cycle 1 Day 1.
  • Subject is receiving systemic steroids at doses greater than the equivalent of prednisone 10 mg daily, with the exception of intermittent use for the treatment of emesis
  • Subject is participating in any other therapeutic clinical study (observational or registry trials are allowed)
  • Female 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 in the study in the judgement of the investigator

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • Sylvester Comprehensive Cancer Center / University of Miami Miller School of Medicine

    Miami, Florida, 33136

  • Columbia University Medical Center

    New York, New York, 10032

  • South Texas Accelerated Research Therapeutics (START)

    San Antonio, Texas, 78229

  • Honor Health

    Scottsdale, Arizona, 85258

Other trials in United States

About this study

Official title: A Phase 1b Dose-escalation Study to Assess Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PLX2853 in Subjects With Advanced Malignancies

The purpose of this research study is to evaluate safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of the investigational drug PLX2853 in subjects with advanced malignancies.

Being tested
PLX2853
Keywords
PLX2853, Small cell lung cancer (SCLC), Uveal Melanoma, Ovarian Clear Cell Carcinoma, Non-Hodgkin Lymphoma, Advanced Malignancies, Solid Tumor, Diffuse Large B Cell Lymphoma (DLBCL), Follicular Lymphoma (FL), ARID1A
Medical subject headings
Small Cell Lung Carcinoma, Uveal Melanoma, Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular

What participants receive

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

  • PLX2853Drug

    Also called PLX2853 tablets

    tablets

Study groups in NCT03297424
Study groupRoleWhat they receive
PLX2853ExperimentalPhase 1b (Dose Escalation): Approximately 45 subjects with advanced malignancies to establish the MTD/RP2D. Up to 6 additional subjects may be enrolled at the MTD/RP2D as a dose confirmation. Phase 2a (Dose Expansion): There will be 5 total expansion cohorts. Either 10 or 29 subjects per cohort in each of 4 expansion cohorts: advanced SCLC, uveal melanoma, OCCC, and any other advanced malignancy with a known ARID1A mutation (between 40 to 116 subjects total for the solid tumor expansion phase). For the 5th expansion cohort, up to 20 subjects may be enrolled for NHL.
Receives: Drug: PLX2853

What is being measured

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

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.

    Measured: First dose of study drug through at least 30 days after end of treatment.

  2. Area under the concentration-time curve (AUC) of PLX2853.

    Measured: From first dose of PLX2853 up to 30 days after end of treatment.

  3. Maximum observed concentration (Cmax) of PLX2853.

    Measured: From first dose of PLX2853 up to 30 days after end of treatment.

  4. Time to peak concentration (Tmax) of PLX2853.

    Measured: From first dose of PLX2853 up to 30 days after end of treatment.

  5. Half life (t1/2) of PLX2853.

    Measured: From first dose of PLX2853 up to 30 days after end of treatment.

  6. Number of participants who experience dose limiting toxicity as defined in the protocol.

    The highest dose level at which less than 2 of 6 participants or less than 33% of participants (if cohort is expanded beyond 6) experience a dose limiting toxicity will be considered the maximum tolerated dose / recommended phase 2 dose.

    Measured: Up to 2 years

  7. Change in disease burden using RECIST 1.1 (solid tumors) or Lugano criteria (NHL).

    Measured: Up to 2 years

Secondary outcomes (4)

  1. Overall response rate (ORR) defined according to standard criteria for the relevant malignancy [Phase1b]

    Measured: From the first dose of study drug until the date of documented response to treatment, assessed up to 2 years.

  2. Duration of response (DOR)

    Measured: DOR defined as the time from the initial objective response to disease progression or death, whichever occurs first, assessed up to 2 years.

  3. Progression-Free Survival (PFS)

    Measured: PFS time is defined as the time from the first dose of PLX2853 to disease progression or death, whichever occurs first, assessed up to 2 years.

  4. Overall Survival (OS)

    Measured: From the first dose of study drug until the date of death from any cause, assessed up to 2 years.

Timeline

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

  1. First posted29 Sep 2017
  2. Study start12 Sep 2017
  3. Primary completion7 Jun 2021
  4. Study completion7 Jun 2021

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03297424
Sponsor's protocol ID
PLX124-01
Status last verified
Jul 2022
First submitted
8 Sep 2017
Last updated
25 Jul 2022
Results posted
No
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 study testing PLX2853 in people with Small Cell Lung Cancer and Uveal Melanoma, run by Opna Bio LLC at 5 sites in United States.

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 12 inclusion and 21 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: finished, as of the sponsor's last update on 25 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. 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 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.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. (time frame: First dose of study drug through at least 30 days after end of treatment.). The study lists 7 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 NCT03297424.

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 25 Jul 2022.

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