Ifetroban in Treating Patients With Malignant Solid Tumors at High Risk of Metastatic Recurrence
Sponsor:
Vanderbilt-Ingram Cancer Center
Collaborators:
Information provided by (Responsible Party):
Ingrid Mayer, MD，Vanderbilt-Ingram Cancer Center
| Tracking Information | |||
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| First Submitted Date ICMJE | September 24, 2018 | ||
| First Posted Date ICMJE | October 3, 2018 | ||
| Last Update Posted Date | October 3, 2018 | ||
| Actual Study Start Date ICMJE | November 2018 | ||
| Estimated Primary Completion Date | November 2021 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE |
Incidence of adverse events[ Time Frame: Up to 30 days after completing treatment ] 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 ] Summarized change of FACT-G score (scale = 0 to 4)[ Time Frame: Up to 12 months ] |
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| Original Primary Outcome Measures ICMJE | Same as current | ||
| Current Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||
| Brief Title ICMJE | Ifetroban in Treating Patients With Malignant Solid Tumors at High Risk of Metastatic Recurrence |
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| Official Title ICMJE | A Pilot Trial of Ifetroban, A Thromboxane A2 Receptor Antagonist, in Patients With Malignant Solid Tumors at High Risk of Metastatic Recurrence |
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| 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. |
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| 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. | ||
| Study Type ICMJE | Interventional | ||
| Study Phase | Phase 2 | ||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Masking: Interventional Masking Description: Primary Purpose: Treatment |
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| Condition ICMJE | |||
| Intervention ICMJE |
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| Study Arms |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Not yet recruiting | ||
| Estimated Enrollment ICMJE |
60 | ||
| Original Estimated Enrollment ICMJE | Same as current | ||
| Estimated Study Completion Date | November 2022 | ||
| Estimated Primary Completion Date | November 2021 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | 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. | ||
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| Ages | 18 Years and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers | No | ||
| Listed Location Countries ICMJE | United States | ||
| Removed Location Countries | |||
| Administrative Information | Has Data Monitoring Committee | Yes | |
| U.S. FDA-regulated Product |
Studies a U.S. FDA-regulated Drug Product: Yes Studies a U.S. FDA-regulated Device Product: No |
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| IPD Sharing Statement |
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| Responsible Party | Ingrid Mayer, MD，Vanderbilt-Ingram Cancer Center | ||
| Study Sponsor ICMJE | Vanderbilt-Ingram Cancer Center | ||
| Collaborators ICMJE | |||
| Investigators ICMJE |
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| PRS Account | Vanderbilt-Ingram Cancer Center | ||
| Verification Date | October 2018 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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