Breast Cancer Clinical Trial
Official title:
An Open-Label, Multiple-Dose, Dose-Escalation Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of VMD-928 in Subjects With Solid Tumors or Lymphoma
NCT number | NCT03556228 |
Other study ID # | VMO-01C |
Secondary ID | |
Status | Recruiting |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | June 8, 2018 |
Est. completion date | June 2026 |
This is a multicenter, open-label, Phase 1 study of orally administered VMD-928 in adult subjects with advanced solid tumors or lymphoma that have progressed or are non responsive to available therapies and for which no standard or available curative therapy exists
Status | Recruiting |
Enrollment | 74 |
Est. completion date | June 2026 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Key Inclusion Criteria: - Histologically or cytologically confirmed diagnosis of any type of solid tumor malignancy or lymphoma that is not responsive to standard therapies or had progressed following standard therapy and for which there is no approved or curative therapy. Additionally, patients must not be candidates for or have exhausted regimens known to provide clinical benefit, including hematopoietic stem cell transplantation in lymphoma patients if they are deemed transplant eligible. - ECOG score of 0 or 1. - Able to swallow and retain oral medication. - Adequate organ system function. - Subjects must either have available archival tumor tissue samples, or consent to tumor tissue sampling prior to the first dose, that is sufficient for IHC analysis of TrkA expression. - Subjects must have a tumor: (i). with TrkA protein overexpression in the validated TrkA IHC assay, OR (ii). with documented NTRK1 gene fusion, or a tumor which has progressed due to NTRK1 mutation after treatment of a pan-Trk inhibitor (e.g. larotrectinib or entrectinib) - Adequate organ system function as defined as follows: 1. Absolute neutrophil count =1.5x10^9/L 2. Hemoglobin =9g/dL 3. Platelets =100x10^9/L 4. PT/INR, PTT =1.5xULN 5. Total bilirubin =1.5x ULN 6. AST, ALT =2.5xULN 7. Creatinine =1.2xULN for age, weight 8. Calculated creatinine clearance or 24h urine creatinine clearance =60mL/min Key Exclusion Criteria: 1. Received chemotherapy having delayed toxicity within the last 14 days (six weeks for prior nitrosourea or mitomycin C). 2. Received anticancer therapy with radiation, immunotherapy, and a biologic, surgery and/or tumor embolization within the past 2 weeks. 3. Received an investigational anticancer drug within 14 days or 5 half-lives of the investigational agent, whichever is longer, prior to the first dose of VMD-928. Any exceptions to the above must be approved by the Sponsor Medical Monitor. 4. Unresolved toxicity from previous anticancer therapy > CTCAE Grade 1 (except alopecia or anemia) unless agreed to by both the Sponsor Medical Monitor and the Investigator. 5. Negative result on TrkA immunohistochemistry (IHC) assay. 6. Known active infections including HIV disease. 7. Patients with a history of chronic viral hepatitis (HBV/HCV) or a history of cirrhotic liver secondary to any etiology (i.e. alcoholism, non-alcoholic steatohepatitis). 8. Currently pregnant, nursing, or planning to become pregnant during the course of the study. 9. QTcF interval = 480 msec. 10. Class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system. 11. Acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting within the past 24 weeks. 12. Unstable or uncompensated respiratory, hepatic, renal, or cardiac disease that would compromise the patient's safety or interfere with assessment of the drug. 13. Psychological, familial, sociological, geographical, or other concurrent conditions that would interfere with safety evaluation, limit the patient's ability to follow the procedures in the protocol or otherwise jeopardize compliance with the protocol. Patients with uncontrolled major depression, bipolar disorder, or severe anxiety disorder are excluded. 14. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to the study drug, or excipients |
Country | Name | City | State |
---|---|---|---|
Puerto Rico | PanOncology Trials, Hospital Oncologico - Puerto Rico Medical Center, Río Piedras | San Juan | |
United States | Gabrail Cancer Center Research | Canton | Ohio |
United States | Erlanger Health System (Hospital); University of Tennessee College of Medicine, Chattanooga | Chattanooga | Tennessee |
United States | City of Hope National Medical Center | Duarte | California |
United States | Englewood Hospital and Medical Center | Englewood | New Jersey |
United States | The University of Texas MD Anderson Cancer Center | Houston | Texas |
United States | Cayuga Medical Center | Ithaca | New York |
United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
United States | Atlantic Health System, Morristown Medical Center | Morristown | New Jersey |
United States | Weill Cornell Medicine, Cornell University | New York | New York |
United States | Memorial Cancer Institute at Memorial Healthcare Systems | Pembroke Pines | Florida |
Lead Sponsor | Collaborator |
---|---|
VM Oncology, LLC |
United States, Puerto Rico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number and severity of treatment-emergent AEs | Within 2 cycles (each cycle is 28 days) | ||
Secondary | Area under the plasma concentration versus time curve (AUC) of VMD-928. | On Day 1 and Day 15 of Cycle 1 (each cycle is 28 days) | ||
Secondary | Peak plasma concentration (Cmax) of VMD-928. | On Day 1 and Day 15 of Cycle 1 (each cycle is 28 days) | ||
Secondary | Incidence of Dose Limiting Toxicities. | During the Cycle 1 (each cycle is 28 days) | ||
Secondary | Analgesic response as defined by the Brief Pain Inventory (BPI). | On Day 1 and Day 15 of Cycle 1 (each cycle is 28 days) | ||
Secondary | Change in TrkA protein expression. | Pre-dose and at the end of Cycle 2 (each cycle is 28 days) | ||
Secondary | Correlation between clinical antitumor and AUC. | Up to the end of the Cycle 2 (each cycle is 28 days) | ||
Secondary | Correlation between clinical antitumor and TrkA protein expression. | Up to the end of the Cycle 2 (each cycle is 28 days) | ||
Secondary | Correlation between analgesic response and TrkA protein expression. | Up to the end of the Cycle 2 (each cycle is 28 days) | ||
Secondary | Correlation between analgesic response and AUC. | Up to the end of the Cycle 2 (each cycle is 28 days) |
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