Trial Summary

This clinical trial will evaluate a novel anti-cancer agent in a limited number of dogs with hemangiosarcoma. All dogs will receive study drug; there is no placebo.

Dogs will receive the study drug as daily, oral treatment with evaluations performed once weekly for the first 28 days, then once monthly. Blood samples are collected throughout the study to assess the metabolism and biological activity of this drug.

During the course of the study, dogs will not be allowed any holistic therapy, chemotherapy, prednisone therapy, non-steroidal anti-inflammatory therapy or other investigational therapies unless approved by the investigator and the sponsor.

Trial Support and Funding

Study drug, diagnostic tests, and follow-up exams will be paid for by the study sponsor. In the event that side effects are attributed to the study drug, the study will pay for medical management of the side effects.

Trial Eligibility

Client-owned pet dogs with measurable hemangiosarcoma lesions (primary or metastatic); OR patients free of gross disease, having undergone splenectomy within the past 28 days.

In addition, cases must meet the following criteria:

• Generally feeling well;
• Prior treatment with chemotherapy acceptable with a required washout of 21 days;
• Prior treatment with non-steroidal anti-inflammatory drugs (NSAID) and prednisone acceptable with a required 14-day washout;
• Prior treatment with radiation therapy is acceptable with a required 30-day washout;
• No prior small molecule inhibitors (i.e. Palladia™);
• No prior immunotherapy (i.e. ONCEPT™ melanoma vaccine).

Trial Participation

The following animal hospitals are offering this clinical trial:

The Oncology Service
Friendship Hospital for Animals
4105 Brandywine St., NW
Washington, DC 20016
(202) 363-7300

The Oncology Service
The LifeCentre
165 Fort Evans Rd. NE
Leesburg, VA 20176
(571) 439-6655

Red Bank Veterinary Hospital
197 Hance Ave.
Tinton Falls, NJ 07724
(732) 747-3636

New England Veterinary Oncology Group
180 Bear Hill Rd., Suite C
Waltham, MA 02451
(781) 684-8688

Veterinary Oncology & Hematology Center, LLC
178 Connecticut Ave
Norwalk, CT 06854
(203) 838-6626

Veterinary Specialty Hospital of the Carolinas
6405 Tyron Rd. Suite 100
Cary, NC 27511
(919) 233-4911

Veterinary Specialty Hospital of San Diego
10435 Sorrento Valley Rd.
San Diego, CA 92121
(858) 875-7500

Status: Closed

Trial Summary

Pet dogs that are enrolled in the study will receive a single dose of a novel, oral anti-cancer agent. Serial blood samples and lymph node aspirates will then be collected over a 24-hour period.  Patients will return for evaluation 7 days after the single dose of therapy is administered.

For participation, clients will receive $2000 towards oncology care.

Trial Eligibility

• Client-owned pet dogs > 1 year of age, 10-45 kg, with life expectancy of > 1 month;
• Informed owner consent prior to initiation of screening/treatment;
• Histological or cytological diagnosis of non-Hodgkins lymphoma with one or more measurable lymph nodes (Minimum tumor diameter is ≥ 20 mm);
• Stage II to V (only substage a) lymphoma of either B or T cell origin;
• Naïve (i.e. de novo) and relapsed cases;
• Favorable Performance Score;
• Prior treatment with chemotherapy or prednisone therapy is accepted but a 14-day washout is required.

Trial Participation

The following sites are evaluating patients for participation in this clinical trial:

The Oncology Service
Friendship Hospital for Animals
4105 Brandywine St., NW
Washington, DC 20016
(202) 363-7300

Red Bank Veterinary Hospital
197 Hance Ave.
Tinton Falls, NJ 07724
(732) 747-3636

New England Veterinary Oncology Group
180 Bear Hill Rd., Suite C
Waltham, MA 02451
(781) 684-8688

Trial Summary

A clinical trial to evaluate a novel anti-cancer therapy is now available. The study is designed into two phases. The initial phase will evaluate the safety of this drug in dogs with any measurable cancer (excluding hemangiosarcoma). The 2^nd phase will evaluate the safety of this drug in dogs with hemangiosarcoma exclusively. No placebo is used.

In both phases, dogs will receive the study drug as daily, oral treatment with evaluations performed once weekly for the first 28 days, then once monthly. Blood sample collection and tumor biopsies are collected throughout the study to assess the metabolism and biological activity of this drug. Dogs with hemangiosarcoma will not receive biopsies.

During the course of the study, dogs will not be allowed any holistic therapy, chemotherapy, or other investigational therapies unless approved by the investigator and the sponsor.

Trial Support and Funding

Study drug, diagnostic tests, and follow-up exams will be paid for by the study sponsor. In the event that side effects are attributed to the study drug, the study will pay for medical management of the side effects.

Client-owned pet dogs that meet the following criteria:

• Histological or cytological diagnosis of cancer - excluding hemangiosarcoma in the first phase of the study;
• Measurable cancer that is amenable to serial biopsy;
• Generally feeling well;
• Prior treatment with chemotherapy accepted but a washout of 21 days is required;
• Prior treatment with non-steroidal anti-inflammatory drugs (NSAID) and prednisone accepted but a 14-day washout is required;
• Prior treatment with radiation therapy is accepted but a 30-day washout is required;
• No prior small molecule inhibitors (i.e. Palladia™);
• No prior immunotherapy (i.e. Melanoma Vaccine);

Trial Participation

The following sites are evaluating patients for participation in this clinical trial:

The Oncology Service
Friendship Hospital for Animals
4105 Brandywine St., NW
Washington, DC 20016
(202) 363-7300

The Oncology Service
The LifeCentre
165 Fort Evans Rd. NE
Leesburg, VA 20176
(571) 439-6655

Red Bank Veterinary Hospital
197 Hance Ave.
Tinton Falls, NJ 07724
(732) 747-3636

New England Veterinary Oncology Group
180 Bear Hill Rd., Suite C
Waltham, MA 02451
(781) 684-8688