Clinical Trials /

Advanced or Recurrent Ovarian, Cervical, and Endometrial Cancer Treated With SHetA2

NCT04928508

Description:

The purpose of this research is to test the safety of the study drug (SHetA2) and see what effects (good and bad) this drug has on patients with recurrent cervical, ovarian, or endometrial cancer.

Related Conditions:
  • Fallopian Tube Carcinoma
  • Ovarian Epithelial Tumor
  • Primary Peritoneal Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Advanced or Recurrent Ovarian, Cervical, and Endometrial Cancer Treated With SHetA2
  • Official Title: Phase 1 Trial of SHetA2 in Patients With Advanced or Recurrent Ovarian, Cervical, and Endometrial Cancer

Clinical Trial IDs

  • ORG STUDY ID: Okgyn1
  • NCT ID: NCT04928508

Conditions

  • Ovarian Cancer
  • Endometrial Cancer
  • Cervix Cancer

Interventions

DrugSynonymsArms
SHetA2NSC 726189SHetA2 capsule

Purpose

The purpose of this research is to test the safety of the study drug (SHetA2) and see what effects (good and bad) this drug has on patients with recurrent cervical, ovarian, or endometrial cancer.

Detailed Description

      SHetA2 capsules will be given twice a day, every day in 21-day blocks of time. Each block of
      time is called a cycle. The cycle will be repeated until the patient or doctor no longer feel
      participation in the study is right for the patient. There will be lab tests and examinations
      to monitor the patients progress. We expect that taking part in this research will last up to
      three years.
    

Trial Arms

NameTypeDescriptionInterventions
SHetA2 capsuleExperimentalSHetA2 (oral, BID) within a 21-days cycle
  • SHetA2

Eligibility Criteria

        Inclusion Criteria:

          -  Patients must have histologic diagnosis of epithelial ovarian, fallopian tube, or
             primary peritoneal carcinoma which is considered platinum resistant (recurrence < 6
             months from last platinum treatment or for whom platinum therapy is no longer
             considered appropriate). Histologic documentation of the original primary tumor is
             required via the pathology report.

        NOTE: Patients with the following histologic ovarian epithelial cell types are eligible:

        High grade serous adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma,
        clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise
        specified (N.O.S.).

        Or

        Patients with recurrent cervical cancer and who have progressed following or refused
        platinum based therapy. Squamous, adenocarcinomas and adenosquamous cancers are eligible.
        Other histologies will be considered if HPV related.

        Or

        Patients with histologically-documented carcinoma of the endometrium, including
        endometrioid, serous, mixed adenocarcinoma, clear-cell carcinoma, or carcinosarcoma.
        Evidence that the endometrial cancer is advanced, recurrent, or persistent and has relapsed
        or is refractory to curative therapy or established treatments.

        Patients must have adequate:

          -  Bone marrow function as defined per protocol

          -  Renal function as defined per protocol

          -  Hepatic function as defined per protocol

          -  International normalized ratio (INR) or prothrombin time (PT) ≤1.5x ULN unless patient
             is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT)
             is within therapeutic range of intended use of anticoagulants

          -  Activated partial thromboplastin time (aPTT) ≤1.5x ULN unless patient is receiving
             anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use
             of anticoagulants

          -  Neurologic function: Neuropathy (sensory and motor) less than or equal to Grade 1.
             Patients should be free of active infection requiring parenteral antibiotics or a
             serious uncontrolled medical illness or disorder within four weeks of study entry.

          -  Any hormonal therapy directed at the malignant tumor must be discontinued at least one
             week prior to registration. Continuation of hormone replacement therapy is permitted.

          -  Patients must have a performance status score of 0-2 by Eastern Cooperative Group
             (ECOG) criteria.

          -  Patients of childbearing potential must have a negative pregnancy test prior to the
             study entry and be practicing an effective form of contraception. If applicable,
             patients must discontinue breastfeeding prior to study entry.

          -  Patients must have satisfactory results for the baseline laboratory analyses and
             diagnostic procedures as specified in the protocol

          -  Patients must have signed an IRB-approved informed consent and authorization
             permitting release of personal health information.

          -  Patients must be at least 18 years old.

          -  Patients in all cohorts must have a fresh pre-treatment tumor biopsy.

          -  Patients must be willing to have fresh biopsy taken post-Cycle 1 treatment

          -  Life expectancy of at least 3 months.

          -  Patients must be able to take oral medications.

          -  Patients with a prior or concurrent malignancy whose natural history or treatment does
             not have the potential to interfere with the safety or efficacy assessment of the
             investigational regimen are eligible for this trial.

        Exclusion Criteria:

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to SHetA2.

          -  A diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other
             form of immunosuppressive therapy within 7 days prior to the first dose of trial
             treatment.

          -  Patients receiving treatment for active autoimmune disease. "Active" refers to any
             condition currently requiring therapy. Examples of autoimmune disease include systemic
             lupus erythematosus, multiple sclerosis, inflammatory bowel disease and rheumatoid
             arthritis. (note if steroid use is <10mg/day prednisolone equivalent and patient has
             stable symptoms they may be allowed on study with discussion with the medical monitor)

          -  Patients with a prior or concurrent malignancy whose natural history or treatment does
             have the potential to interfere with the safety or efficacy assessment of the
             investigational regimen are NOT eligible for this trial.

          -  Known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or
             hepatitis C (e.g., hepatitis C virus ribonucleic acid [HCV RNA] [qualitative] is
             detected). Ongoing systemic bacterial, fungal, or viral infection; known human
             immunodeficiency virus (HIV) infection with positive viral load or acquired
             immunodeficiency syndrome (AIDS)-related illness. Patients with HIV and a negative
             viral load are allowed on study.

          -  Patients with concurrent severe medical problems unrelated to the malignancy that
             would significantly limit full compliance with the study or expose the patient to
             extreme risk or decreased life expectancy.

          -  Patients with history or evidence upon physical examination of CNS disease, including
             primary brain tumor, seizures not controlled with standard medical therapy, any brain
             metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic
             attack (TIA) or subarachnoid hemorrhage within six months of the first date of
             treatment on this study.

        NOTE: Patients with previously treated brain metastases may participate provided they are
        stable (without evidence of progression by imaging (using the identical imaging modality
        for each assessment, either magnetic resonance imaging [MRI] or computed tomography [CT]
        scan) for at least 4 weeks prior to the first dose of trial treatment and any neurologic
        symptoms have returned to baseline), have no evidence of new or enlarging brain metastases,
        and are not using steroids for at least 7 days prior to trial treatment. Carcinomatous
        meningitis precludes a patient from study participation regardless of clinical stability

          -  Patients taking concomitant therapy with any of the following: other non-study
             cytotoxic chemotherapy; other investigational therapies.

          -  Prior bone marrow/hematopoietic stem cell transplantation

          -  History of solid organ, bone marrow, or progenitor cell transplantation

          -  History of major surgical procedure within 28 days prior to start of study treatment
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of dose-limiting toxicities of treatment with SHetA2
Time Frame:21 days
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Rate of objective response
Time Frame:up to three years
Safety Issue:
Description:
Measure:Median duration of response
Time Frame:up to three years
Safety Issue:
Description:
Measure:Rate of disease control
Time Frame:up to three years
Safety Issue:
Description:
Measure:Median progression free survival
Time Frame:up to three years
Safety Issue:
Description:
Measure:Median overall survival
Time Frame:up to three years
Safety Issue:
Description:
Measure:Incidence of adverse events
Time Frame:up to three years
Safety Issue:
Description:safety and tolerability of SHetA2 using Common Terminology Criteria for Adverse Events (CTCAE) v.5.0
Measure:Tmax of PK plasma concentration
Time Frame:24 hours
Safety Issue:
Description:
Measure:Cmax of PK plasma concentration
Time Frame:24 hours
Safety Issue:
Description:
Measure:AUC of PK plasma concentration
Time Frame:24 hours
Safety Issue:
Description:
Measure:t1/2 of PK plasma concentration
Time Frame:24 hours
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:University of Oklahoma

Last Updated

June 16, 2021