AMG 386 and Abiraterone for Advanced Prostate Cancer

Completed · Phase 2

Conditions studied: Prostatic Neoplasms, Prostate Cancer, Neoplasm, Prostate, Neoplasm,Prostatic

In brief

Background: * Advanced prostate cancer is treated with surgery or drugs that lower the levels of androgens (male hormones) in the body. However, some cancers become resistant to this treatment. These types of cancers are known as castration-resistant prostate cancers. * Interfering with the growth of blood vessels that feed tumors can slow prostate cancer growth. Trebananib (AMG 386), a new anticancer drug, targets the blood vessels that feed tumors. It has been tested for different types of cancer, but not for prostate cancer. Researchers want to see if AMG 386 can slow disease progression in men with castration-resistant prostate cancer. AMG 386 will be given with abiraterone and prednisone, two drugs that are also used to treat advanced prostate cancer. Objectives: \- To test the safety and effectiveness of AMG 386 with abiraterone for castration-resistant prostate cancer. Eligibility: \- Men at least 18 years of age with castration-resistant prostate cancer. Design: * Participants will be screened with a physical exam, medical history, and imaging studies. Blood and urine samples will also be collected. * Participants will be separated into two groups. * The first group will have AMG 386 once per week for a total of four doses during a 28-day cycle. They will also take abiraterone once a day and prednisone twice a day, every day of the cycle. * The second group will not have AMG 386. They will take abiraterone once a day and prednisone twice a day, every day of the 28-day cycle. * Treatment will be monitored with frequent blood tests and imaging studies. * Participants will continue to take the study drugs as long as the disease does not progress and there are no severe side effects.

Key facts

Study ID

NCT01553188

Run by

National Cancer Institute (NCI)

People needed

36

Starts

2012-02-08

Expected to finish

2018-07-01

Last updated by the study team

2019-03-05

Who can join

Age: 18 and older, up to 100. Sex: male. Healthy volunteers: not accepted.

You may not qualify if…

• Patients who have had chemotherapy for metastatic castration-resistant prostate cancer.
• History or presence of known central nervous system metastases.
• History of venous or arterial thromboembolism within 12 months prior to enrollment/randomization.
• History of clinically significant bleeding within 6 months of enrollment/randomization.
• Currently or previously treated with AMG 386, or other molecules that primarily inhibit the angiopoietins or Tie2 receptor.
• Clinically significant cardiovascular disease within 12 months prior to enrollment/randomization, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, congestive heart failure, or arrhythmias not controlled by outpatient medication or placement of percutaneous transluminal coronary angioplasty/stent.
• Major surgery within 28 days prior to enrollment or still recovering from prior surgery.
• Minor surgical procedures, placement of tunneled central venous access device within 3 days prior to randomization/enrollment.
• Treatment within 30 days prior to enrollment with the following: cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, methotrexate, azathioprine, rapamycin, and targeted immune modulators such as abatacept (CTLA-4-Ig), adalimumab,
• alefacept, anakinra, belatacept (LEA29Y), efalizumab, etanercept, infliximab, or rituximab.
• Patients who have had large field radiotherapy must wait 2 weeks prior to entering the study.
• Non-healing wound, ulcer (including gastrointestinal), or fracture.
• Contraindication to steroid use or history of allergic reactions attributable to the study compounds.
• History of allergic reactions to bacterially-produced proteins.
• Previously diagnosed with another malignancy, within the past two years with the exception of non-melanoma skin cancers or non-invasive bladder cancer.
• Patients who have not yet completed at least 28 days (30 days for prior monoclonal antibody therapy) since receiving other investigational drugs.
• Inability to absorb abiraterone after oral administration (i.e., previous major gastrointestinal surgery or gastrointestinal disease resulting in malabsorption).
• Use of ketoconazole, itraconazole, ritonavir, cyclosporine, carbamazepine, phenytoin, phenobarbital within 2 weeks prior to and while on study therapy.
• Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with the study agents. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive
• therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
• Uncontrolled intercurrent illness or infections, unstable angina pectoris, cardiac arrythmias, renal dysfunction, or psychiatric illness/social situations that would limit compliance with study requirements.
• Have had treatment with docetaxel for the treatment of metastatic castrate-sensitive prostate cancer within 6 months before the first dose of study enrollment.
• Have had progression of prostate cancer on prior docetaxel treatment for castrate sensitive disease.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.