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Ifetroban in Treating Patients With Malignant Solid Tumors at High Risk of Metastatic Recurrence

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ClinicalTrials.gov Identifier: NCT03694249
Recruitment Status : Recruiting
First Posted : October 3, 2018
Last Update Posted : December 20, 2018
Sponsor:
Collaborator:
Cumberland Pharmaceuticals
Information provided by (Responsible Party):
Ingrid Mayer, MD, Vanderbilt-Ingram Cancer Center

Brief Summary:
This pilot trial studies the side effects of ifetroban in treating patients with malignant solid tumors that are at high risk of coming back after treatment and spreading throughout the body. Platelets are a type of blood cells that help with clotting. Cancer cells stick to platelets and ride on them to get to different parts of the body. Drugs, such as ifetroban, may help these platelets become less "sticky," and reduce the chance of cancer cells spreading to other places in the body.

Condition or disease Intervention/treatment Phase
Anatomic Stage II Breast Cancer Anatomic Stage IIA Breast Cancer Anatomic Stage IIB Breast Cancer Anatomic Stage III Breast Cancer Anatomic Stage IIIA Breast Cancer Anatomic Stage IIIB Breast Cancer Anatomic Stage IIIC Breast Cancer Clinical Stage II Esophageal Adenocarcinoma Clinical Stage II Esophageal Squamous Cell Carcinoma Clinical Stage II Gastric Cancer Clinical Stage II Gastroesophageal Junction Adenocarcinoma Clinical Stage IIA Esophageal Adenocarcinoma Clinical Stage IIA Gastric Cancer Clinical Stage IIA Gastroesophageal Junction Adenocarcinoma Clinical Stage IIB Esophageal Adenocarcinoma Clinical Stage IIB Gastric Cancer Clinical Stage IIB Gastroesophageal Junction Adenocarcinoma Clinical Stage III Esophageal Adenocarcinoma Clinical Stage III Esophageal Squamous Cell Carcinoma Clinical Stage III Gastric Cancer Clinical Stage III Gastroesophageal Junction Adenocarcinoma Distal Esophagus Squamous Cell Carcinoma Esophageal Carcinoma Estrogen Receptor Negative HER2/Neu Negative Limited Stage Small Cell Lung Carcinoma Malignant Solid Neoplasm Non-Small Cell Lung Carcinoma Pancreatic Adenocarcinoma Pathologic Stage II Esophageal Adenocarcinoma Pathologic Stage II Esophageal Squamous Cell Carcinoma Pathologic Stage II Gastric Cancer Pathologic Stage II Gastroesophageal Junction Adenocarcinoma Pathologic Stage IIA Esophageal Adenocarcinoma Pathologic Stage IIA Esophageal Squamous Cell Carcinoma Pathologic Stage IIA Gastric Cancer Pathologic Stage IIA Gastroesophageal Junction Adenocarcinoma Pathologic Stage IIB Esophageal Adenocarcinoma Pathologic Stage IIB Esophageal Squamous Cell Carcinoma Pathologic Stage IIB Gastric Cancer Pathologic Stage IIB Gastroesophageal Junction Adenocarcinoma Pathologic Stage III Esophageal Adenocarcinoma Pathologic Stage III Esophageal Squamous Cell Carcinoma Pathologic Stage III Gastric Cancer Pathologic Stage III Gastroesophageal Junction Adenocarcinoma Pathologic Stage IIIA Esophageal Adenocarcinoma Pathologic Stage IIIA Esophageal Squamous Cell Carcinoma Pathologic Stage IIIA Gastric Cancer Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma Pathologic Stage IIIB Esophageal Adenocarcinoma Pathologic Stage IIIB Esophageal Squamous Cell Carcinoma Pathologic Stage IIIB Gastric Cancer Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma Pathologic Stage IIIC Gastric Cancer Postneoadjuvant Therapy Stage II Esophageal Adenocarcinoma Postneoadjuvant Therapy Stage II Esophageal Squamous Cell Carcinoma Postneoadjuvant Therapy Stage II Gastric Cancer Postneoadjuvant Therapy Stage II Gastroesophageal Junction Adenocarcinoma Postneoadjuvant Therapy Stage III Esophageal Adenocarcinoma Postneoadjuvant Therapy Stage III Esophageal Squamous Cell Carcinoma Postneoadjuvant Therapy Stage III Gastric Cancer Postneoadjuvant Therapy Stage III Gastroesophageal Junction Adenocarcinoma Postneoadjuvant Therapy Stage IIIA Esophageal Adenocarcinoma Postneoadjuvant Therapy Stage IIIA Esophageal Squamous Cell Carcinoma Postneoadjuvant Therapy Stage IIIA Gastroesophageal Junction Adenocarcinoma Postneoadjuvant Therapy Stage IIIB Esophageal Adenocarcinoma Postneoadjuvant Therapy Stage IIIB Esophageal Squamous Cell Carcinoma Postneoadjuvant Therapy Stage IIIB Gastroesophageal Junction Adenocarcinoma Progesterone Receptor Negative Prognostic Stage II Breast Cancer Prognostic Stage IIA Breast Cancer Prognostic Stage IIB Breast Cancer Prognostic Stage III Breast Cancer Prognostic Stage IIIA Breast Cancer Prognostic Stage IIIB Breast Cancer Prognostic Stage IIIC Breast Cancer Stage I Pancreatic Cancer Stage IA Pancreatic Cancer Stage IB Pancreatic Cancer Stage II Lung Cancer Stage II Pancreatic Cancer Stage IIA Lung Cancer Stage IIA Pancreatic Cancer Stage IIB Lung Cancer Stage IIB Pancreatic Cancer Stage III Lung Cancer Stage IIIA Lung Cancer Stage IIIB Lung Cancer Stage IIIC Lung Cancer Triple-Negative Breast Carcinoma Drug: Ifetroban Sodium Other: Placebo Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. To assess the safety and feasibility of ifetroban sodium (ifetroban) administration in patients with malignant solid tumors at high risk of metastatic recurrence, after completion of all planned (neo)adjuvant locoregional and systemic therapies.

SECONDARY OBJECTIVES:

I. To assess rate of metastatic recurrence after completion of ifetroban in patients with malignant solid tumors.

EXPLORATORY OBJECTIVES:

I. To quantify pharmacodynamic markers of ifetroban effects.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP 1 (IFETROBAN): Patients receive ifetroban sodium orally (PO) once daily (QD). Courses repeat every 28 days for 12 months in the absence of disease progression or unacceptable toxicity.

GROUP 2 (PLACEBO): Patients receive a placebo PO QD. Courses repeat every 28 days for 12 months in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days, then up to 12 months.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Pilot Trial of Ifetroban, A Thromboxane A2 Receptor Antagonist, in Patients With Malignant Solid Tumors at High Risk of Metastatic Recurrence
Actual Study Start Date : December 12, 2018
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2023


Arm Intervention/treatment
Experimental: Group 1 (ifetroban)
ifetroban capsule (250mg) will be taken by mouth daily.
Drug: Ifetroban Sodium
Given by mouth

Placebo Comparator: Group 2 (placebo)
Placebo capsule (250mg) will be taken by mouth daily.
Other: Placebo
Given by mouth




Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: Up to 30 days after completing treatment ]
  2. Adherence to treatment (participants will be provided a pill diary to record when they take their medication. Study staff will collect the pill diary from participants at their clinic visits). [ Time Frame: Up to 12 months ]
  3. Summarized change of FACT-G score (scale = 0 to 4) [ Time Frame: Up to 12 months ]

Secondary Outcome Measures :
  1. Percentage of patients within metastatic recurrence (within each cohort) [ Time Frame: At 12 months ]
  2. Event-free survival (within each cohort) [ Time Frame: Up to 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed and dated written informed consent.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.
  • One of the following current diagnoses:

    • Stage IIa to III triple negative breast cancer (TNBC).
    • Stage I to II pancreatic adenocarcinoma.
    • Lung Cancer.

      • Stage IIa to III non-small cell lung cancer (NSCLC).
      • Limited stage small cell lung cancer (SCLC).
    • Stage IIa to III esophageal or gastroesophageal (GE) junction cancers (squamous cell carcinoma [SCCA] or adenocarcinoma).
    • Stage IIa to III stomach cancer.
  • Patients must have completed all standard locoregional and systemic therapy for their cancer.
  • Administration of an investigational agent prior to enrollment needs to be completed at least 30 days prior to enrollment.
  • Patients must have recovered (=< grade 1 toxicities) from effects of local (surgery, radiation) or systemic treatments.
  • Platelet count >= 100,000 per mL of blood.
  • Hemoglobin >= 9/g/dL (may have been transfused).
  • Serum creatinine =< 1.5 x upper limit of normal (ULN) or estimated creatinine clearance >= 50 mL/min as calculated using the Cockcroft-Gault (CG) equation.
  • Total serum bilirubin =< 1.5 times upper limit of normal (ULN).
  • Aspartate aminotransferase (AST/serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT/serum glutamate-pyruvate transaminase [SGPT]) =< 2.5 x ULN.
  • International normalized ratio (INR) below upper limit of normal (ULN).
  • Female patients of childbearing potential and non-sterile males must agree to use at least two methods of acceptable contraception from 15 days prior to first trial treatment administration until at least 5 months after study participant's final dose of study drug.

    * Note: Females of childbearing potential are defined as those who are not surgically sterile or post-menopausal (i.e. patient has not had a bilateral tubal ligation, a bilateral oophorectomy, or a complete hysterectomy; or has not been amenorrheic for 12 months without an alternative medical cause). Post-menopausal status in females under 55 years of age should be confirmed with a serum follicle-stimulating hormone (FSH) level within laboratory reference range for postmenopausal women. Non-sterile males are those who have not had a vasectomy with documentation of the absence of sperm in the ejaculate.

  • Patients unable to read/write in English are eligible to participate in the overall study but will not participate in the Patient-Reported Outcome questionnaires throughout the trial.
  • Re-enrollment of a subject that has discontinued the study as a pre-treatment screen failure (i.e. a consented patient who did not receive study drugs) is permitted. If reenrolled, the subject must be re-consented. Only the screening procedures performed outside of protocol-specified timing must be repeated.

Exclusion Criteria:

  • Clinical evidence of residual or distant disease after completion of standard treatment.
  • Current use of anti-platelet drugs (acetylsalicylic acid [ASA], nonsteroidal anti-inflammatory drugs [NSAIDs], clopidogrel, argatroban, etc.) or anticoagulants (warfarin, heparin products, etc.).
  • Active malignancy within 5 years prior to current diagnosis except for in situ disease or cancer with very high curability rate (i.e. testicular cancer, etc.).
  • Uncontrolled co-morbid serious systemic illnesses that in the opinion of the investigator could compromise therapeutic safety.
  • No concurrent anticancer therapy. Required washout from prior therapy:

    • Chemotherapy: 21 days.
    • Major surgery: 14 days (provided wound healing is adequate).
    • Radiation: 7 days.
    • Investigational/Biologic Therapy: 30 days.
  • Current symptomatic congestive heart failure (New York Heart Association > class II), unstable cardiac arrhythmia requiring therapy (e.g. medication or pacemaker), unstable angina (e.g. new, worsening or persistent chest discomfort), or uncontrolled hypertension (systolic > 160 mmHg or diastolic > 100mmHg). Or any of the following occurring within 6 months (180 days) prior to first dose of study drugs: Myocardial infarction, coronary/peripheral artery bypass graft, cerebrovascular accident or transient ischemic attack. (Use of antihypertensive medication to control blood pressure is allowed.)
  • Ongoing peptic ulcer disease requiring treatment. History of gastrointestinal bleed. Severe gastro-esophageal reflux disease requiring treatment.
  • History of bleeding diathesis.
  • Planned elective major surgical intervention while taking ifetroban.
  • Pregnant or breastfeeding females.
  • Prisoners or subjects who are involuntarily incarcerated.
  • Known psychiatric condition, social circumstance, or other medical condition reasonably judged by the patient's study physician to unacceptably increase the risk of study participation; or to prohibit the understanding or rendering of informed consent or anticipated compliance with scheduled visits, treatment schedule, laboratory tests and other study requirements.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03694249


Contacts
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Contact: Vanderbilt-Ingram Service for Timely Access 800-811-8480 cip@vanderbilt.edu

Locations
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United States, Tennessee
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Vanderbilt-Ingram Service for Timely Access    800-811-8480    cip@vanderbilt.edu   
Principal Investigator: Ingrid Mayer, MD         
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Cumberland Pharmaceuticals
Investigators
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Principal Investigator: Ingrid Mayer, MD Vanderbilt-Ingram Cancer Center

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Responsible Party: Ingrid Mayer, MD, Principal Investigator, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT03694249     History of Changes
Other Study ID Numbers: VICC MD1854
NCI-2018-01930 ( Registry Identifier: NCI, Clinical Trials Reporting Program )
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: December 20, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Platelet Aggregation Inhibitors
Carcinoma
Breast Neoplasms
Lung Neoplasms
Carcinoma, Squamous Cell
Adenocarcinoma
Pancreatic Neoplasms
Stomach Neoplasms
Recurrence
Carcinoma, Non-Small-Cell Lung
Esophageal Squamous Cell Carcinoma
Esophageal Neoplasms
Neoplasms
Small Cell Lung Carcinoma
Triple Negative Breast Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplasms, Squamous Cell
Digestive System Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases