Posts by catharine

ORAL MELANOMA STUDY IN DOGS

August 29th, 2022 Posted by Melanoma, Oncology 0 thoughts on “ORAL MELANOMA STUDY IN DOGS”

Trial Overview

This fully funded, randomized, placebo-controlled clinical trial will assess a potential new treatment for oral melanoma in dogs.


Eligibility

  • Diagnosis of Stage III oral melanoma (not confined to lip)
  • At least one measurable lesion with a longest diameter of ≥ 10 mm (≥ 15 mm short axis for lymph node lesions)
  • Prior surgery acceptable (if performed at least 14 days prior to enrollment) if measurable disease remains which meets above criteria
  • No lung metastasis
  • No prior Oncept® melanoma vaccine
  • Dog must weigh at least 3 kg (6.6 lb)
  • Other study criteria may apply. The Investigator will decide if the dog is a good candidate for this study after examination.


Trial Details

  • Investigational product or placebo once every 2 weeks for approximately 6 months (15 scheduled visits)
  • All trial visits must occur at one of the designated trial clinics listed below
  • Periodic lab work and thoracic radiographs (x-rays) will be performed to assess each dog’s overall health
  • Owners are required to sign a consent form before their dog is enrolled, complete owner diaries at home and complete a single quality-of-life assessment question at each trial visit
  • At study end, dogs are eligible to receive the investigational product in a separate clinical trial

 

Study Sites

Dallas, TX
Malvern, PA
Middleton, WI
Overland Park, KS
San Diego, CA
Washington, DC

Additional study sites coming soon!

 


 

If you are interested in enrolling your pet or being an Investigator on this study, please contact ACI by completing the form below.

  • This field is for validation purposes and should be left unchanged.

OTITIS EXTERNA STUDY

April 29th, 2022 Posted by Otitis 0 thoughts on “OTITIS EXTERNA STUDY”

Does your clinic see dogs with relapsing otitis externa? If so, and the dogs have had at least 3 fully resolved relapses of OE within a 13-month period, or 2 fully resolved relapses within a 4-month period, you may be interested in a clinical field study looking at prevention of OE recurrence in dogs with relapsing OE.

The study is a 6 month long multicenter, placebo-controlled clinical study evaluating the efficacy and safety of a ready-to-use investigational veterinary product applied to the ears.

This study is fully funded.

For full eligibility requirements and further information, please contact a study site.

Study Sites

Advance, NC
Dallas, TX
Garner, NC
Quakertown, PA

Additional study sites coming soon!

 


 

If interested in enrolling your pet or being an Investigator on this study, please contact ACI by completing the form below.

  • This field is for validation purposes and should be left unchanged.

A MULTI-CENTER PIVOTAL STUDY TO DETERMINE THE EFFECTIVENESS AND SAFETY OF AN INVESTIGATIONAL VETERINARY PRODUCT FOR THE TREATMENT OF LYMPHOMA IN DOGS

April 6th, 2022 Posted by Lymphoma, Oncology 0 thoughts on “A MULTI-CENTER PIVOTAL STUDY TO DETERMINE THE EFFECTIVENESS AND SAFETY OF AN INVESTIGATIONAL VETERINARY PRODUCT FOR THE TREATMENT OF LYMPHOMA IN DOGS”

Study Specifics

This randomized, double-masked, placebo-controlled, GCP pivotal field study is evaluating the effectiveness and safety of verdinexor for the treatment of naïve or first relapse stages II, III and IV lymphoma in client owned dogs. Diagnosis of lymphoma must be confirmed by cytology or biopsy for the dog to be eligible for this study. Dogs will be randomized to receive the investigational veterinary product or a placebo treatment (tablets) to be administered with food twice weekly at least 72 hours apart for 8 weeks.  After receiving treatment in-hospital on Day 0, the dog will be required to return to the study site on Days 7, 14, 28, 42, and 56 for follow up evaluation visits. Owners will be required to report and record abnormal daily observations and dosing using a phone app at home throughout the study.


Funding

This study is fully funded. Funding includes the initial study screening, the study treatment and administration, scheduled study lab work, recheck visits and exams, and management of side effects that are thought to be directly related to participation in the study.


Eligibility

Dogs are eligible if they meet the following inclusion criteria:

  • Written informed owner consent has been obtained prior to screening.
  • Dog is ≥ 1 year, weighs ≥ 9 kg and has a life expectancy of at least 28 days.
  • Dog has naïve or first relapse lymphoma:
    • Naïve: dog who has not received any treatment for lymphoma.
    • First relapse: dog has failed a single round of any chemotherapy completed at least 14-days prior to study entry and has recovered from any acute toxicity from prior chemotherapy or is on prednisone and has exhibited progressive disease.
  • Evidence of disease (progression) at the time of screening is based on direct measurement of at least one peripheral lymph node ≥ 20 mm longest diameter (LD).
  • Dog has histological or cytological diagnosis of B-cell or T-cell lymphoma (confirmed by flow cytometry prior to or during screening procedures), stages II, III, or IV:
    • Stage II: Regional lymphadenopathy (restricted to one side of diaphragm)
    • Stage III: Generalized lymphadenopathy (enlargement of lymph nodes)
    • Stage IV: Hepatosplenomegaly (provided there is also lymphadenopathy such that the Investigator can assess disease status through a physical exam)
  • A modified Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1 [0 = normal activity, 1 = restricted activity, decreased from pre-disease status].
  • If on NSAIDs treatment, the dog has been treated for more than 2 weeks prior to enrollment.

 

Dogs are not eligible if they meet the following exclusion criteria:

  • Dog has stage I lymphoma.
  • Dog has clinical evidence of stage V lymphoma involving the CNS, gastrointestinal tract, or pulmonary system.
  • Conditions that may interfere with the outcome of the study:
    • Clinically relevant abnormal laboratory results (e.g., lymphocyte count greater than 15,000 per μL)
    • Serious, concurrent medical condition (e.g., renal, cardiovascular, hepatic, endocrine, concurrent malignancy)
    • Significant bulky disease such that clinical deterioration is likely to occur even in the setting of stable disease.
  • Dog has received:
    • Prior radiation specifically for the treatment of lymphoma.
    • Any immunotherapy for the treatment of lymphoma.
  • Dog is receiving complementary or alternative medicines that the Investigator believes could interfere with the primary endpoint of the study.
  • Dog is participating in another study or is receiving an investigational therapy.
  • Dog that is lactating, pregnant, or intended for breeding.

 

Study Sites

Akron, OH
Bartlesville, OK
Dallas, TX
Denver, NC
Franklin, IN
Madison, WI
Malvern, PA
North Grafton, MA
Quakertown, PA
Salt Lake City, UT

Additional study sites coming soon!

 


 

If interested in enrolling your pet or being an Investigator on this study, please contact ACI by completing the section below.

  • This field is for validation purposes and should be left unchanged.

PILOT SAFETY AND EFFECTIVENESS STUDY OF A NOVEL STEM CELL THERAPY PREPARATION IN CLIENT-OWNED CATS WITH CHRONIC KIDNEY DISEASE (CKD)

November 10th, 2021 Posted by Chronic Kidney Disease 0 thoughts on “PILOT SAFETY AND EFFECTIVENESS STUDY OF A NOVEL STEM CELL THERAPY PREPARATION IN CLIENT-OWNED CATS WITH CHRONIC KIDNEY DISEASE (CKD)”

Study Specifics

This GCP study conducted at multiple clinical study sites will evaluate the safety and effectiveness of a novel stem cell therapy preparation in cats with naturally occurring chronic kidney disease (CKD). The study veterinarian will administer the stem cell therapy by intravenous injection on Day 0 and 14. The study will compare the investigational veterinary product (IVP) to a placebo control product (CP). Cats at a given clinic will be randomly assigned to treatment group with a 2:1 group enrollment ratio. Follow-up visits/testing or phone follow-ups are required monthly. Throughout the study the owner will be required to observe and record any abnormal observations and assess food and water intake.


Funding

This is a fully funded study that includes seven scheduled clinic visits occurring at least once before treatment for screening (2 to 3 weeks prior), once for each treatment (Day 0 and 14), and four times thereafter (Days 30, 60, 90, 180). Funding includes the initial consultation, the study treatment and administration, recheck visits, and management of side effects that are thought to be directly related to participation in the study.


Eligibility

Cats that meet eligibility criteria and have a diagnosis of stage 2 or 3 CKD with no other diseases that would interfere with the study objectives, may enroll in the study. The study veterinarian will determine the stage of the cat’s kidney disease and discuss the complete list of study requirements.
 

Study Sites

Dallas, TX
Malvern, PA
Middleton, WI
Overland Park, KS
San Diego, CA
Washington, DC

Additional study sites coming soon!

If you are interested in enrolling your pet or being an Investigator on this study, please contact ACI at https://www.animalci.com/contact/ or call (301) 841-0014.

DOSE DETERMINATION STUDY: INVESTIGATING THE USE OF PERI-NEURAL (PN) ADMINISTRATION OF A NOVEL THERAPY FOR THE CONTROL OF CLINICAL SIGNS ASSOCIATED WITH REFRACTORY NAVICULAR SYNDROME IN HORSES

November 9th, 2021 Posted by Pain Management 0 thoughts on “DOSE DETERMINATION STUDY: INVESTIGATING THE USE OF PERI-NEURAL (PN) ADMINISTRATION OF A NOVEL THERAPY FOR THE CONTROL OF CLINICAL SIGNS ASSOCIATED WITH REFRACTORY NAVICULAR SYNDROME IN HORSES”

Study Specifics

This is a non-GCP, randomized, masked, placebo-controlled study in client owned horses with a history of refractory navicular disease. The objective of this study is to evaluate the effectiveness and safety of an investigational veterinary product to control pain when administered perineurally to horses with refractory navicular disease or who are candidates for a neurectomy due to refractory navicular disease. Screening activities will take place at least 24 hours prior and up to 14 days in advance of treatment administration on Day 0. This 60-day study involves a one-time injectable treatment of investigational veterinary product administered to both forelimbs. An estimated 30 client-owned horses will be enrolled. After receiving treatment on Day 0, the horse will be required to either remain in the clinic until Day 3 or return to the study site on Days 3, 14, 28, and 60 for follow up evaluation visits. Owners will be required to report and record abnormal daily observations throughout the study. As necessary, the horse may return for additional evaluation during unscheduled visits.


Funding

The study is fully funded for the entire duration of the study. Study visits includes the initial study consultation, treatment Day 0, evaluation visits on Day 3, 14, 28, and 60. In addition to management of side effects that are thought to be directly related to participation in the study.


Eligibility

Horses are eligible if they meet the following inclusion criteria:

  • Written informed owner consent has been obtained prior to screening procedures.
  • The horse is at least 2 years old.
  • In general good health or stabilized for chronic conditions as assessed by physical examination, medical history and clinical pathology evaluations.
  • Lack of response to treatment of navicular disease and/ or owner considering neurectomy as treatment for chronic navicular disease.
  • Unilateral or bilateral forelimb lameness of Grade 2, 3, or 4 using the AAEP Lameness Scale (0 to 5 scale).
  • Positive response to anesthesia of the medial and lateral distal palmar digital nerves of the affected forelimbs.
  • Radiographic evidence of degenerative changes associated with navicular disease (e.g. elevated number of or abnormally shaped lucent zones, subcortical stenosis, enthesophyte formation of the navicular bone) in one or both navicular bones.

 
Horses are not eligible if they meet the following exclusion criteria:

  • Hindlimb lameness or lameness other than in the front hooves that could confound the lameness exams
  • Horse is less than 2 years of age
  • A change in shoeing or trimming within 2 weeks of enrollment. Shoeing and trimming are required to remain consistent throughout the study.
  • Use of medications to treat navicular disease or drugs that could mask lameness (e.g. NSAIDs, isoxsuprine, steroids, clodronate (Osphos), tiludronic acid (Tildren)) within 2 weeks of starting the study
  • Evidence of a neurectomy
  • History of episodes of colic in the past 4 weeks preceding treatment with a novel therapy
  • May be unavailable for the entire study duration or is felt to be unsuitable by the Investigator for any other reason

 

Study Sites
Sallisaw, OK

Additional study sites coming soon!

If you are interested in enrolling your pet or being an Investigator on this study, please contact ACI at https://www.animalci.com/contact/ or call (301) 841-0014.

COLLECTION OF CYTOLOGY SAMPLES FROM CATS AND DOGS WITH VARIOUS MEDICAL CONDITIONS

November 5th, 2021 Posted by Sample Collection 0 thoughts on “COLLECTION OF CYTOLOGY SAMPLES FROM CATS AND DOGS WITH VARIOUS MEDICAL CONDITIONS”

Study Specifics

The study is a sample collection study conducted at 10 different ACI-affiliated clinics.  Oncology, Dermatology and Emergency clinics are involved.  1500 samples will be collected from cats and dogs.


Study Funding

The study provides a $20 stipend to owners who consent to a sample collection from their pet.


Study Eligibility

Any pet with a lesion in which routine cytology collection can be obtained is eligible.


Study Sites

Charlotte, NC
Greenville, SC
Las Vegas, NV
Leesburg, VA
Richmond, VA
Tustin, CA
Washington, DC

Additional study sites coming soon!

If you are interested in enrolling your pet or being an Investigator on this study, please contact ACI at https://www.animalci.com/contact/ or call (301) 841-0014.

Coming Soon

Equine Lameness Study

Stay tuned for more information and enrollment.

Veterinarians interested in joining our network of professionals in clinical trials, contact us for more details.