LY2157299 Monohydrate (LY2157299) and Radiotherapy in Metastatic Breast Cancer

Stopped early · Phase 2

Conditions studied: Metastatic Breast Cancer

In brief

Patients with metastatic breast cancer receiving at least one single agent chemotherapy and demonstrating stable disease or disease progression at two consecutive clinical/radiological assessments (at an interval of at least 2 weeks). Transforming growth factor-beta (TGFΒ) blockade will enhance response of irradiated tumors and improve the function of Dendritic and T cells. Patients will receive 300 mg/day of study drug administered via oral drug tablet every day for 14 days on and 14 days off (=28 day cycle). Radiation to a metastatic site will be delivered at a dose of 7.5 Gy, given consecutively on days 1-3-5.

Key facts

Study ID

NCT02538471

Run by

Weill Medical College of Cornell University

People needed

3

Starts

2015-08-10

Expected to finish

2019-02-20

Last updated by the study team

2019-12-09

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Biopsy proven breast carcinoma which is persistent and metastatic or recurrent and metastatic.
• Patients must have failed at least one line of chemotherapy for metastatic disease.
• Patients who are Human epidermal growth factor 2 +(HER2+) as defined by American Society of Clinical Oncology and College of American Pathologists (ASCO CAP) guidelines must have failed all prior therapy known to confer clinical benefit
• Patients must have at least 3 distinct metastatic sites with at least one measurable lesion which is at least 1 cm or larger in largest diameter
• At the time of enrollment, patients must be ≥ 4 weeks since all of the following treatments (and recovered from the toxicity of prior treatment to <= Grade 1, exclusive of alopecia):
• major surgery; radiotherapy; chemotherapy (note: must be ≥ 6 weeks since therapy if treated with a nitrosourea, mitomycin, or monoclonal antibodies such as bevacizumab); immunotherapy; Biotherapy/targeted therapies.
• Patient ≥ 18 years of age. Patient life expectancy > 6 months. Eastern cooperative group (ECOG) of 0 or 1
• Adequate organ function including:
• Marrow: Hemoglobin >= 10.0 g/dL, absolute neutrophil count (ANC) >=1,500/mm3, and platelets >=100,000/mm3.
• Hepatic: Serum total bilirubin <=1.5 x upper limit of normal (ULN) (Patients with Gilbert's Disease may be included if their total bilirubin is <= 3.0 mg/dL), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) <= 2.5 x ULN. If the patient has known liver metastases, an ALT and/or AST <= 5 x ULN are allowed.
• Renal: Estimated or measured creatinine clearance >= 60 mL/min.
• Other: Prothrombin time (PT) and partial thromboplastin time (PTT) < ULN.
• Patients must have negative tests (antibody and/or antigen) for hepatitis viruses B and C unless the result is consistent with prior vaccination or prior infection with full recovery.
• Male and female patients of child-producing potential must agree to use effective contraception while enrolled on study and receiving the experimental drug, and for at least 3 months after the last treatment.

You may not qualify if…

• Patients diagnosed with another malignancy - unless following curative intent therapy, the patient has been disease free for at least 2 years and the probability of recurrence of the prior malignancy is < 5%. Patients with curatively treated early-stage squamous cell carcinoma of the skin, basal cell carcinoma of the skin, or cervical intraepithelial neoplasia (CIN) are eligible for this study.
• Concurrent cancer therapy is not permitted.
• Uncontrolled central nervous system (CNS) metastases, meningeal carcinomatosis, malignant seizures, or a disease that either causes or threatens neurologic compromise (e.g., unstable vertebral metastases).
• History of ascites or pleural effusions, unless successfully treated.
• Patients with an organ transplant, including those that have received an allogeneic bone marrow transplant.
• Patients on immunosuppressive therapy including:
• Systemic corticosteroid therapy for any reason, including replacement therapy for hypoadrenalism. Patients receiving inhaled or topical corticosteroids may participate (if therapy is < 5 days and is limited to systemic steroids as antiemetics).
• Patients receiving cyclosporine A, tacrolimus, or sirolimus are not eligible for this study.
• Use of investigational agents within 4 weeks prior to study enrollment (within 6 weeks if the treatment was with a long-acting agent such as a monoclonal antibody).
• Patients with moderate or severe cardiac disease:
• have the presence of cardiac disease, including a myocardial infarction within 6 months prior to study entry, unstable angina pectoris, New York Heart Association Class III/IV congestive heart failure, or uncontrolled hypertension.
• have documented major electrocardiogram (ECG) abnormalities (not responding to medical treatments) at the investigator's discretion (for example, symptomatic or sustained atrial or ventricular arrhythmias, second- or third-degree atrio ventricular block, complete bundle branch block, ventricular hypertrophy, or recent myocardial infarction).
• have major abnormalities documented by echocardiography (ECHO) with Doppler (for example, moderate or severe heart valve function defect and/or left ventricular ejection fraction <50%, evaluation based on the institutional lower limit of normal). For additional details, refer to ECHO protocol.
• have predisposing conditions that are consistent with development of aneurysms of the ascending aorta or aortic stress (for example, family history of aneurysms, Marfan-Syndrome, bicuspid aortic valve, evidence of damage to the large vessels of the heart documented by computed tomography (CT) scan with contrast).
• B-type Natriuretic Peptide (BNP) above 3 times the baseline value and above the ULN that is sustained consecutive, scheduled blood draws. Troponin I above ULN, high sensitive C-reactive protein (hsCRP) above ULN or Cystatin above ULN.
• Patients with a remote history of asthma or active mild asthma may participate.
• Active infection, including unexplained fever (temperature > 38.5 deg.C).
• Systemic autoimmune disease (e.g., systemic lupus erythematosus, active rheumatoid arthritis, Marfan Syndrome, etc.).
• A known allergy to any component of LY2157299.
• Patients who, in the opinion of the Investigator, have significant medical or psychosocial problems that warrant exclusion. Examples of significant problems include, but are not limited to:
• Other serious non-malignancy-associated medical conditions that may be expected to limit life expectancy or significantly increase the risk of Serious Adverse Events (SAEs).
• Any condition, psychiatric, substance abuse, or otherwise, that, in the opinion of the Investigator, would preclude informed consent, consistent follow-up, or compliance with any aspect of the study
• Pregnant or nursing women, due to the unknown effects ofLY2157299 on the developing fetus or newborn infant.

Where it is running

• Weill Cornell Medical College — New York, New York, United States

Full record on ClinicalTrials.gov

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