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Proef van de werkzaamheid en veiligheid van korte en lange bestralingstherapie met/zonder BMX-001

30 september 2026 bijgewerkt door: University of Nebraska

Een gerandomiseerde fase 2-studie naar de werkzaamheid en veiligheid van korte en lange bestralingstherapie met en zonder BMX-001 als onderdeel van totale neoadjuvante therapie bij patiënten met nieuw gediagnosticeerd lokaal gevorderd rectaal adenocarcinoom

In this Phase 2 study, we will conduct an efficacy and safety study of the combination of investigational drug BMX-001, with short-course radiotherapy (SCRT) or long-course chemoradiotherapy (LCCRT) as part of total neoadjuvant therapy in newly diagnosed rectal adenocarcinoma (RAC) patients.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

In this trial, we will enroll patients in two cohorts:

Cohort 1: A 6 patient safety lead-in for patients receiving capecitabine prior to beginning a randomized trial for the Long Course Chemo-radiation (LCCRT) cohort. There will be trial stopping rules to review safety and PK data prior to initiating the randomized trial of patients receiving LCCRT.

Cohort 2: The Randomized Short Course Radiation (SCRT) cohort.

Cohort 1 and 2 will begin enrolling concurrently. Cohort 1 will have a safety lead-in of patients receiving LCCRT (with capecitabine). Cohort 2 will begin with the randomized study of patients receiving SCRT, while the LCCRT cohort is going through the safety lead-in portion.

There are stopping rules for the LCCRT cohort 1 pending PK analysis as well as an AE review from the treatment period plus 1 week post BMX-001 treatment for the 6 patients prior to moving on with the randomized portion of the study for the LCCRT cohort. All patients in the safety lead-in portion of the trial will receive BMX-001 (A loading dose of 28 mg/subject followed by maintenance doses of 14 mg/subject twice a week) with either SCRT or LCCRT. Patients will receive 3 cycles of FOLFOX or 2 cycles of CAPOX and then be assigned to SCRT or LCCRT prior to randomization. Patients will be randomized (stratified by gender) to BMX-001 or no BMX-001. The randomized trial in each cohort will involve SCRT or LCCRT with or without BMX-001. After conclusion of radiation, patients will then receive 6 more cycles of FOLFOX or 4 more cycles of CAPOX. Skin, GI, and GU symptoms will be measured on the day of screening, before and after RT.

Studietype

Ingrijpend

Inschrijving (Geschat)

118

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Verenigde Staten
    • Kentucky
      • Lexington, Kentucky, Verenigde Staten, 40536
        • Werving
        • Markey Cancer Center
        • Contact:
        • Contact:
          • Cynthia A Leedham, Ph.D
          • Telefoonnummer: 859-257-4470
          • E-mail: cleed2@uky.edu
        • Hoofdonderzoeker:
          • Mark E Bernard, MD
    • Nebraska
      • Omaha, Nebraska, Verenigde Staten, 68198
        • Werving
        • University of Nebraska Medical Center
        • Hoofdonderzoeker:
          • Chi Lin, MD, Ph.D
        • Contact:
    • Texas
      • San Antonio, Texas, Verenigde Staten, 78229
        • Werving
        • UT Health San Antonio MD Anderson Cancer Center
        • Contact:
        • Contact:
        • Hoofdonderzoeker:
          • Neil B Newman, MD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  1. Patients with pathologically confirmed locally advanced rectal adenocarcinoma who will be receiving total neoadjuvant therapy regimen with curative intent.
  2. AJCC stage II to III rectal adenocarcinoma that will require total neoadjuvant therapy.
  3. Adult, age > or equal to 18 years (for Nebraska, age of consent is ≥19 years old)
  4. ECOG Performance Status 0-2
  5. Hemoglobin ≥ 9.0 g/dl, ANC ≥ 1,500 /dl, platelets ≥ 100,000 /dl (The use of transfusion or other intervention to achieve Hgb > 9.0 g/dl is acceptable)
  6. Serum SGOT and bilirubin ≤ 1.5 times upper limit of normal
  7. Adequate renal function defined as follows:

1)Serum creatinine < 1.5 mg/dl within 2 weeks prior to enrollment or 2)Creatinine clearance (CC) ≥ 50 ml/min within 2 weeks prior to enrollment determined by 24-hour collection or estimated by Cockcroft-Gault formula: CCr male = [(140 - age) x (wt in kg)]/[(Serum Cr mg/dl) x (72)], CCr female = 0.85 x (CrCl male) 8. Signed, written informed consent prior to completing any study specific procedures 9. Negative pregnancy test for women of child-bearing potential at the time of screening 10. Women of childbearing potential and male participants must agree to use two forms of a medically effective means of birth control throughout their participation in the treatment phase of the study and until 12 months following the last study treatment 11. Chest/Abdominal/Pelvic (CAP) CT/ pelvic MRI done within 8 weeks prior to randomization.

Exclusion Criteria:

  1. Breast-feeding or pregnant

  2. Active infection requiring IV antibiotics 7 days before enrollment

  3. Prior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ, basal cell or carcinoma of the skin, invasive cancers with a 5-year disease-free interval, resected cancer of the bladder or low-grade (Gleason 6 or less) prostate cancer

  4. Prior history of rectal adenocarcinoma (RAC)

  5. Prior history of pelvic radiotherapy for any other type of malignancy

  6. Known hypersensitivity or contraindication to any agent in FOLFOX or CAPOX regimen.

  7. Because corticosteroids are anti-inflammatory and could interrupt oxidative stress, patients will be excluded unless they are on stable or decreasing corticosteroids dose at the time of randomization.

    BMX-001 Specific Exclusion Criteria (Subjects meeting any of the following criteria are ineligible for study entry)

  8. Inadequately controlled hypertension (defined as systolic blood pressure >150 mmHg and/or diastolic blood pressure > 100 mmHg)

  9. Active or history of postural hypotension and autonomic dysfunction within the past year

  10. Known hypersensitivity to BMX-001

  11. Clinically significant (i.e. active) cardiovascular disease or cerebrovascular disease, for example cerebrovascular accidents ≤ 6 months prior to study enrollment, myocardial infarction ≤ 6 months prior to study enrollment, unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure (CHF), or serious cardiac arrhythmia uncontrolled by medication or potentially interfering with protocol treatment

  12. History or evidence upon physical/neurological examination of central nervous system disease (e.g. seizures) unrelated to cancer unless adequately controlled by medication or potentially interfering with protocol treatment

  13. Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months prior to start of study treatment

  14. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 milliseconds (ms) (CTCAE grade 1) using the specific/usual choice by clinical center for correction factor.

  15. A history of additional risk factors for Torsades de Pointes (TdP) (e.g., congestive heart failure, hypokalemia, known family history of Long QT Syndrome).

Note: Inclusion of Women and Minorities Both men and women and members of all races and ethnic groups are eligible for this trial.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Arm A

Short Chemo-Radiation Therapy (SCRT) + BMX-001
Geneesmiddel: BMX-001

Loading dose of 28 mg per subject, followed by maintenance doses of 14 mg per subject twice per week.
Geen tussenkomst: Arm B

Short Chemo-Radiation Therapy (SCRT)
Experimenteel: Arm C

Long Course Chemo-Radiation Therapy (LCCRT) + BMX-001
Geneesmiddel: BMX-001

Loading dose of 28 mg per subject, followed by maintenance doses of 14 mg per subject twice per week.
Geen tussenkomst: Arm D

Long Course Chemo-Radiation Therapy (LCCRT)

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Efficacy of BMX-001 as measured by Grade 3 and above associated with gastrointestinal Toxicities
Tijdsspanne: Three weeks (During and 2 weeks after RT)

Grade 3 and above radiation-associated gastrointestinal, genitourinary, skin and hematologic toxicity (SCRT or LCCRT) including frequency, severity and duration of rectal bleeding, rectal pain, diarrhea, dysuria, hematuria, urinary frequency, radiation dermatitis and thrombocytopenia
Three weeks (During and 2 weeks after RT)
Efficacy of BMX-001 as measured by Grade 3 and above associated with genitourinary Toxicities
Tijdsspanne: Three weeks (During and 2 weeks after RT)

Grade 3 and above radiation-associated gastrointestinal, genitourinary, skin and hematologic toxicity (SCRT or LCCRT) including frequency, severity and duration of rectal bleeding, rectal pain, diarrhea, dysuria, hematuria, urinary frequency, radiation dermatitis and thrombocytopenia
Three weeks (During and 2 weeks after RT)
Efficacy of BMX-001 as measured by Grade 3 and above associated with skin Toxicities
Tijdsspanne: Three weeks (During and 2 weeks after RT)

Grade 3 and above radiation-associated gastrointestinal, genitourinary, skin and hematologic toxicity (SCRT or LCCRT) including frequency, severity and duration of rectal bleeding, rectal pain, diarrhea, dysuria, hematuria, urinary frequency, radiation dermatitis and thrombocytopenia
Three weeks (During and 2 weeks after RT)
Efficacy of BMX-001 as measured by Grade 3 and above associated with hematologic Toxicities
Tijdsspanne: Three weeks (During and 2 weeks after RT)

Grade 3 and above radiation-associated gastrointestinal, genitourinary, skin and hematologic toxicity (SCRT or LCCRT) including frequency, severity and duration of rectal bleeding, rectal pain, diarrhea, dysuria, hematuria, urinary frequency, radiation dermatitis and thrombocytopenia
Three weeks (During and 2 weeks after RT)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Nebraska

Medewerkers

BioMimetix JV, LLC

Onderzoekers

  • Hoofdonderzoeker: Chi Lin, MD, PhD, University of Nebraska

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

15 augustus 2022

Primaire voltooiing (Geschat)

1 mei 2030

Studie voltooiing (Geschat)

1 juni 2034

Studieregistratiedata

Eerst ingediend

14 februari 2022

Eerst ingediend dat voldeed aan de QC-criteria

14 februari 2022

Eerst geplaatst (Werkelijk)

24 februari 2022

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 oktober 2026

Laatste update ingediend die voldeed aan QC-criteria

30 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 0012-22-FB
  • BMX-RAC-001 (Andere identificatie: BioMimetix JV, LLC)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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