Trebananib in Treating Patients With Advanced Angiosarcoma That Cannot Be Removed by Surgery

NCT01623869 | Completed Phase 2 Results

• 6 other identifiers: NCI-2012-01978CDR0000735380CALGB-A091103A091103U10CA180821U10CA031946
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 70

Brief Summary

This phase II trial studies how well trebananib works in treating patients with advanced angiosarcoma that cannot be removed by surgery. Trebananib may stop the growth of tumor cells by blocking blood flow to the tumor.

Conditions

Adult Angiosarcoma; Recurrent Adult Soft Tissue Sarcoma; Stage III Adult Soft Tissue Sarcoma; Stage IV Adult Soft Tissue Sarcoma

Outcome Measures

Primary Outcomes (1)

• Confirmed Response Rate (CR or PR) Using RECIST

  Response and progression will be evaluated using the international RECIST guidelines (v1.1). Patients are evaluated every 8 weeks for disease status, with a subsequent 4 week assessment required to confirm a response. Complete Response (CR) - All of the following must be true: 1. Disappearance of all target and non-target lesions, 2. Each target lesion and non-target lymph node must have reduction in short axis to \<1.0 cm. Partial Response (PR): 1. At least a 30% decrease from the baseline measurements of the sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation. 2. Persistence of one or more non-target lesions or non-target lymph nodes. The confirmed response rate is estimated as the number of patients having a CR or PR, divided by the number of eligible patients having at least one post-baseline assessment. The 95% confidence intervals provided using the method of Duffy and Santner.

  Up to 18 months

Secondary Outcomes (2)

• Progression Free Survival (PFS)

  From the start of treatment to time of radiologic or clinical progression or death, whichever occurs first, assessed up to 18 months

• OS

  From the date of registration to the date of death or the date of last follow-up, assessed up to 18 months

Study Arms (1)

Treatment (trebananib)

EXPERIMENTAL

Patients receive 30 mg/kg trebananib IV over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Other: Laboratory Biomarker Analysis; Biological: Trebananib

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (trebananib)

Trebananib BIOLOGICAL

Given IV

Also known as: AMG 386, Angiopoietin 1/2-Neutralizing Peptibody AMG 386

Treatment (trebananib)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically confirmed angiosarcoma that is unresectable
• Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors(RECIST) 1.1, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as \>= 2 cm with conventional techniques or as \>= 1 cm with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam
• Patients must have had =\< 4 prior systemic treatment regimens
• Eastern Cooperative Oncology Group (ECOG) 0-1 or Karnofsky \>= 70%
• Life expectancy of greater than 3 months
• Leukocytes \>= 3,000/mcL
• Absolute neutrophil count \>= 1,500/mcL
• Hemoglobin \>= 8.5g/dL
• Platelet count \>= 60,000/mcL
• Total bilirubin =\< 1.5 times institutional upper limit of normal (ULN)
• Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\]) =\< 2.5 times institutional ULN
• Alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase\[SGPT\]) =\< 2.5 times institutional ULN
• Partial thromboplastin time (PTT) or activated (a)PTT =\< 1.5 times ULN per institutional laboratory range
• International normalized ratio(INR) =\< 1.5 (unless on warfarin)
• Creatinine =\< 1.5 times ULN OR creatinine clearance \> 40 mL/min per 24-hour urine collection or calculated according to the Cockcroft-Gault formula

You may not qualify if:

• No known history of brain metastases
• History of clinically significant bleeding within 6 months of enrollment/randomization
• No unresolved toxicities from prior systemic therapy that are Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 \>= grade 2 in severity except alopecia
• Currently or previously treated with AMG 386, or other molecules that 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 (CTCAE version 4.0) 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
• Treatment within 30 days prior to enrollment with strong immune modulators including, but not limited to, systemic cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, methotrexate, azathioprine, rapamycin, thalidomide, lenalidomide, and targeted immune modulators such as abatacept (CTLA-4- -Ig),adalimumab, alefacept, anakinra, belatacept (LEA29Y), efalizumab, etanercept, infliximab, or rituximab
• Non-healing wound
• Subject not consenting to the use of highly effective contraceptive precautions (e.g., double barrier method \[i.e., condom plus diaphragm\]) during the course of the study and for 6 months after administration of the last study medication
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to AMG 386
• History of allergic reactions to bacterially-produced proteins
• Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
• Patients who have not yet completed at least 21 days (30 days for prior monoclonal antibody therapy) since ending other investigational device or drug trials, or who are currently receiving other investigational treatments
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Non-pregnant, non-nursing; Note: Women of child bearing potential must have a pregnancy test, serum based within 7 days prior to registration; this is because AMG 386 is an inhibitor of angiogenesis with the potential for teratogenic or abortifacient effects

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (70)

Beebe Medical Center

Lewes, Delaware, 19958, United States

Location

Christiana Care Health System-Christiana Hospital

Newark, Delaware, 19718, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Oncare Hawaii Inc-POB II

Honolulu, Hawaii, 96813, United States

Location

Queen's Medical Center

Honolulu, Hawaii, 96813, United States

Location

Straub Clinic and Hospital

Honolulu, Hawaii, 96813, United States

Location

University of Hawaii Cancer Center

Honolulu, Hawaii, 96813, United States

Location

Oncare Hawaii Inc-Kuakini

Honolulu, Hawaii, 96817, United States

Location

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826, United States

Location

Castle Medical Center

Kailua, Hawaii, 96734, United States

Location

Wilcox Memorial Hospital and Kauai Medical Clinic

Lihue, Hawaii, 96766, United States

Location

Oncare Hawaii Inc-Pali Momi

‘Aiea, Hawaii, 96701, United States

Location

Pali Momi Medical Center

‘Aiea, Hawaii, 96701, United States

Location

Saint Joseph Medical Center

Bloomington, Illinois, 61701, United States

Location

Illinois CancerCare-Bloomington

Bloomington, Illinois, 61704, United States

Location

Graham Hospital Association

Canton, Illinois, 61520, United States

Location

Illinois CancerCare-Canton

Canton, Illinois, 61520, United States

Location

Illinois CancerCare-Carthage

Carthage, Illinois, 62321, United States

Location

Memorial Hospital

Carthage, Illinois, 62321, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Eureka Hospital

Eureka, Illinois, 61530, United States

Location

Illinois CancerCare-Eureka

Eureka, Illinois, 61530, United States

Location

Illinois CancerCare Galesburg

Galesburg, Illinois, 61401, United States

Location

Illinois CancerCare-Havana

Havana, Illinois, 62644, United States

Location

Mason District Hospital

Havana, Illinois, 62644, United States

Location

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, 61443, United States

Location

Illinois CancerCare-Macomb

Macomb, Illinois, 61455, United States

Location

Mcdonough District Hospital

Macomb, Illinois, 61455, United States

Location

Holy Family Medical Center

Monmouth, Illinois, 61462, United States

Location

Illinois CancerCare-Monmouth

Monmouth, Illinois, 61462, United States

Location

Bromenn Regional Medical Center

Normal, Illinois, 61761, United States

Location

Community Cancer Center Foundation

Normal, Illinois, 61761, United States

Location

Illinois CancerCare-Community Cancer Center

Normal, Illinois, 61761, United States

Location

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, 61350, United States

Location

Ottawa Regional Hospital and Healthcare Center

Ottawa, Illinois, 61350, United States

Location

Illinois CancerCare-Pekin

Pekin, Illinois, 61554, United States

Location

Pekin Cancer Treatment Center

Pekin, Illinois, 61554, United States

Location

Methodist Medical Center of Illinois

Peoria, Illinois, 61603, United States

Location

Proctor Hospital

Peoria, Illinois, 61614, United States

Location

Illinois CancerCare-Peoria

Peoria, Illinois, 61615, United States

Location

Illinois Oncology Research Association CCOP

Peoria, Illinois, 61615, United States

Location

OSF Saint Francis Medical Center

Peoria, Illinois, 61637, United States

Location

Illinois CancerCare-Peru

Peru, Illinois, 61354, United States

Location

Illinois Valley Hospital

Peru, Illinois, 61354, United States

Location

Illinois CancerCare-Princeton

Princeton, Illinois, 61356, United States

Location

Perry Memorial Hospital

Princeton, Illinois, 61356, United States

Location

Illinois CancerCare-Spring Valley

Spring Valley, Illinois, 61362, United States

Location

Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Franciscan Saint Francis Health-Indianapolis

Indianapolis, Indiana, 46237, United States

Location

Reid Hospital and Health Care Services

Richmond, Indiana, 47374, United States

Location

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242, United States

Location

Siouxland Regional Cancer Center

Sioux City, Iowa, 51101, United States

Location

Mercy Medical Center-Sioux City

Sioux City, Iowa, 51104, United States

Location

Saint Luke's Regional Medical Center

Sioux City, Iowa, 51104, United States

Location

Union Hospital of Cecil County

Elkton MD, Maryland, 21921, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Cooper Hospital University Medical Center

Camden, New Jersey, 08103, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Grandview Hospital

Dayton, Ohio, 45405, United States

Location

Good Samaritan Hospital - Dayton

Dayton, Ohio, 45406, United States

Location

Miami Valley Hospital

Dayton, Ohio, 45409, United States

Location

Samaritan North Health Center

Dayton, Ohio, 45415, United States

Location

Dayton CCOP

Dayton, Ohio, 45420, United States

Location

Blanchard Valley Hospital

Findlay, Ohio, 45840, United States

Location

Atrium Medical Center-Middletown Regional Hospital

Franklin, Ohio, 45005-1066, United States

Location

Wayne Hospital

Greenville, Ohio, 45331, United States

Location

Kettering Medical Center

Kettering, Ohio, 45429, United States

Location

Upper Valley Medical Center

Troy, Ohio, 45373, United States

Location

Greene Memorial Hospital

Xenia, Ohio, 45385, United States

Location

MeSH Terms

Conditions

Hemangiosarcoma; Sarcoma

Interventions

trebananib

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue

Results Point of Contact

• Title: Sandra Pierina D'Angelo, M.D.
• Organization: Memorial Sloan-Kettering Cancer Center

dangelos@mskcc.org

Study Officials

• Sandra D'Angelo

  Alliance for Clinical Trials in Oncology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2012
• First Posted: June 20, 2012
• Study Start: July 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: February 1, 2015
• Last Updated: October 19, 2015
• Results First Posted: July 2, 2015

Record last verified: 2015-06

Locations

US (70)