Combination Trametinib and Sapanisertib Clinical Trial Pilot Study for Canine Malignant Neoplasia

Patient Disease:

Canine Malignant Neoplasia

Study Name:

Purpose of the study:

To evaluate the safety, biologic effects, and antitumor activity of combined trametinib and sapanisertib given to dogs with measurable malignant tumors.

Primary Eligibility Criteria:

Weight at least 6 kg (13 lb) but no more than 40 kg (88 lb)
Cytologically or histologically confirmed diagnosis of malignant neoplasia with disease that is able to measured and is accessible for biopsy
Mast cell tumors and hemangiosarcoma excluded
Adequate blood work
3 week washout from chemotherapy, 6 weeks from radiation therapy, one month from immunotherapy
No concurrent NSAID treatment
Pets must come to CSU for all visits related to the clinical trial

Study Protocol:

Dogs will receive trametinib orally once daily and sapanisertib orally every 3 days
Recheck visits are required on Days 6, 15, 27, and 57 after starting treatment, then every 4 weeks thereafter, as long as their disease is not worsening and the drugs are well tolerated
Overnight hospitalization for serial blood sample collection will occur after the first dose is given and at the Day 27 visit
Tumor biopsies will be performed prior to starting treatment and at the visits on Days 6 and 27

Owner Responsibilities:

You are responsible for the initial testing to determine study eligibility and any other tests recommended by your pet’s oncologist
You are expected to make and keep all appointments associated with the study
You must be comfortable administering oral medications to your dog daily and keeping a written log of drug administration and any side effects

Financial Incentives:

All costs related to the study including exam fees, drug dispensing, blood and urine monitoring, overnight hospitalization for sample collection, imaging if necessary to determine tumor size, and tumor biopsies will be covered by the clinical trial
Participating owners will receive a $750 credit to their dog’s VTH account, which can be applied to the costs associated with initial testing if the dog qualifies for the study, or used to defray costs associated with other cancer treatment when the study is complete

If you have further questions about any of our clinical trials, please submit an online consult form. Your consult will then be directed to our trials team. Requests are typically returned within 5 business days.