CLINICAL STUDIES

TOWARDS ONE MEDICINE FOR HUMAN & PETS

ONGOING CLINICAL STUDIES – CANINE AND FELINE SPECIES

ONCOLOGY

Innovative immunotherapy for solid tumors (recruitment in progress)

16-ONCO-07 

Innovative immunotherapy for solid tumors

Objectives

To evaluate the efficacy and safety of a new immunotherapy for the treatment of solid tumors accessible to injections

Indications 

Solid tumor of the head and neck, skin tumor, melanoma, breast carcinoma, soft tissue sarcoma

Primary criteria 

To evaluate tumor response and treatment safety after combined intratumoral and intravenous injection

Study duration 

7 weeks including :

– 1 inclusion visit ;

– 2 treatments cycles with hospitalization

– 2 follow-up visits

– Surgical resection of the tumor

Assessment 

Clinical and biological examination (blood and urine samples), CT scan, tumor analysis after surgery

Oral treatment for cerebral gliomas (recruitment in progress)

22-BIV-01

Oral treatment for cerebral gliomas (recruitment in progress)

Objective 

To evaluate the efficacy and safety of an innovative oral treatment for high-grade gliomas

Primary criteria 

To evaluate tumor response and safety of oral therapy

Study duration 

Active phase : 6 weeks of treatment with MRI follow-up

Follow-up phase : follow-up MRI 6 weeks after treatment discontinuation

Assessment 

– Clinical, neurological, biological (blood samples) and MRI examination

– Clinical costs covered by the study

– Extensive preclinical and clinical safety package including pet dogs with high-grade glioma

– Close monitoring of tumor progression

Innovative monoclonal antibody treatment for canine tumors (recruitment in progress)

22-ORK-03

Innovative monoclonal antibody treatment for canine tumors (recruitment in progress)

Objective 

To evaluate the efficacy and safety of monoclonal antibody therapy in companion dogs with metastatic, recurrent or resistant cancer

Study description 

Compassionate protocol for dogs with metastatic, recurrent or resistant cancer

Indications 

Mast cell tumor, breast tumor including inflammatory breast carcinoma, soft tissue sarcoma, melanoma, osteosarcoma, hemangiosarcoma, cutaneous lymphoma (mycosis fungoides), transitional cell carcinoma, myeloma, squamous cell carcinoma or any other carcinoma

Primary criteria 

To assess the objective tumor response and safety of intravenous monoclonal antibody infusion

Study duration 

10-12 weeks comprising 8 visits including 3 study product infusions and 4 control visits

Assessment 

Clinical examination, blood and urine analysis, tumor imaging

MEDICAL DEVICES

Osteoarthritis of the elbow or stifle (recruitment in progress)

20-THV-07 

Osteoarthritis of the elbow or stifle (recruitment in progress)

Objective 

To confirm the efficacy and safety of a single intra-articular administration of the investigational product in the treatment of osteoarthritis of the elbow or stifle in dogs

Primary criteria 

To evaluate the efficacy of the investigational product in reducing the severity of osteoarthritis symptoms, including pain reduction and improved mobility

Study duration 

1 screening visit + 1 visit for intra-articular injection of investigational product or treatment simulation + 1 follow-up visit per month for 3 months

Assessment 

Clinical (clinical examination, questionnaires to be completed by owner and veterinarian)

Medical device for circulating tumor cells capture (recruitment in progress)

23-SMC-01 

Medical device for circulating tumor cells capture (recruitment in progress)

Objective 

To assess the safety and efficacy of a medical device for circulating tumor cells (CTCs) capture

Study description 

In vitro compliance study of a medical device for circulating tumor cells (CTC) capture in blood samples (18mL) from dogs of carcinoma owners

Primary criteria

Check that cancerous canine blood is not altered during micro-filtration by the CTC capture device, by assessing hemolysis.

Inclusion criteria 

Adult dog weighing at least 15 kg, fully grown, vaccination up to date, malignant carcinoma with confirmed metastases or at high risk of metastases (histopathology, cytology available).

Study duration

 1 hour per animal

Assessment 

Clinical examination, blood sampling for inclusion (CBC and blood smear), study blood sample (18 mL)

OTHER DISEASES

Oral treatment for alveolar bone loss (recruitment in progress)

21-VBX-02 :

Oral treatment for alveolar bone loss (recruitment in progress)

Objective 

To evaluate the efficacy and tolerability of an innovative oral treatment for the reduction of alveolar bone loss in periodontal disease

Primary criteria 

Assessment of blood marker, alveolar bone loss by CT scan and periodontal disease parameters

Study duration 

60 to 90 days depending on treatment duration

Assessment 

Clinical examination; biological (blood samples); CT scan; assessment of periodontal parameters

Food supplement for pre-diabetic cats (recruitment in progress)

22-ING-01 :

Food supplement for pre-diabetic cats (recruitment in progress)

Objective 

To evaluate the long-term safety and efficacy of a dietary supplement on blood glucose homeostasis in cats with spontaneously developing pre-diabetes

Study description 

Food supplement for cats with pre-diabetes

Primary criteria 

To evaluate the effectiveness of the dietary supplement on blood glucose homeostasis by assessing changes in blood parameter values

Study duration 

2 months study per cat, with 3 visits

Assessment 

Clinical examination; Blood and urine sampling; Follow-up with owner book

Post-sterilization weight maintenance (recruitment completed)

22-RCA-02 

Post-sterilization weight maintenance (recruitment completed)

Objective 

To evaluate the efficacy of a weight maintenance diet and its acceptance in neutered dogs

Primary criteria 

To evaluate the effectiveness of 4 dry food recipes for weight maintenance in dogs after sterilization, and assess small dog owners’ perceptions of 2 wet foods

To evaluate owner and dog satisfaction with dry and wet foods

Study duration 

2 months to 2 months and 2 weeks, depending on inclusion group

Assessment 

Clinical (clinical examination, weight measurement and questionnaires)

Oral treatment for osteoarthritis in dogs (recruitment in progress)

22-VBX-01 :

Oral treatment for osteoarthritis in dogs (recruitment in progress)

Objective 

Aims to evaluate the efficacy and tolerability of a new treatment for osteoarthritis in dogs

Study description 

Aims to evaluate the efficacy and safety of a new treatment for osteoarthritis in dogs. This anti-inflammatory treatment is an A3 adenosine receptor inhibitor, and has an excellent safety profile based on preclinical and clinical results in humans. It is designed to meet the veterinary market’s need for safe, effective anti-inflammatory treatments with few side effects.

Primary criteria 

To evaluate the efficacy of an innovative treatment to reduce the severity of osteoarthritis symptoms, assessed on the dog’s mobility using an owner questionnaire

Study duration 

3 months

Assessment 

Clinical examination, blood test, veterinary and owner questionnaires, activity monitor

Atopic dermatitis (recuitment in progress)

S21068-00 

Atopic dermatitis (recuitment in progress)

Objective 

To evaluate the efficacy and safety of a new treatment for atopic dermatitis

Primary criteria 

To evaluate the efficacy of the treatment in reducing the symptoms of atopic dermatitis, as well as its tolerability

Study duration 

1 month for one group of dogs with a visit every two weeks

4 months for the other group, with a visit every two weeks for one month, then one visit per month

Assessment 

Clinical (clinical examination, questionnaires), biological (blood and urine samples)

CONTACTS

OCR – Bâtiment IRCL2 Place de Verdun – CS30038 -59041 LILLE Cedex
+33 (0)6 63 51 39 71 – mdubruque@oncovet-clinical-research.com – www.oncovet-clinical-research.com

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in the field of comparative pathology, an international growing sector.