Ontario

NO LONGER RECRUITING – Active locations in Ontario:

• Toronto – University Health Network (Albiruni Razak: albiruni.razak@uhn.ca)

ID Number: NCT03465722

Links:

• Canadian Cancer Trials
• ClinicalTrials.gov

Description: This study looks at the drug Avapritnib (BLU-285) for patients with advanced or metastatic a Gastrointestinal Stromal Tumor (GIST) compared to Regorafenib. Patients will take one of the two study drugs over 2 months and the researchers will compare their survival and disease status over time to decide which medication is more effective.

• Group A will receive Avapritnib.
• Group B will receive a Regorafenib.

Intervention: Both of the drugs being compared in this study are meant to stop cancer cells from spreading. Regorafenib is a kinase inhibitor. This means that it stops cancer cells from producing certain proteins they need to survive and divide. It is widely used to treat various types of cancer. Avapritnib looks like a promising new treatment which can stop cancer cells from dividing. This trial will help to figure out if it is helpful in treating a specific type of gastric cancer.

Can I consider participating?

• Yes: adult patients with an unresectable GIST who have already been treated with a medication called imatinib, as well as 1-2 other medications which are tyrosine kinase inhibitors (TKIs)
• No: patients who have been treated with Avapritnib or Regorafenib in the past; patients who have tried 3 or more TKI medications in the past

Publications: Robust Activity of Avapritinib, Potent and Highly Selective Inhibitor of Mutated KIT, in Patient-derived Xenograft Models of Gastrointestinal Stromal Tumors

Recruiting location in Ontario:

• Toronto – Princess Margaret Cancer Centre (Dr. Marcus Butler: 416-946-4501 ext 5485)

ID Number: NCT03132922

Link:

• ClinicalTrials.gov
• Canadian Cancer Trials

Description: This is a Phase I trial. It is not limited to gastric cancer; many types of cancer patients whose tumor expresses the MAGE-A4 protein may participate. Because this is a Phase I trial, all participants will receive the treatment.

Intervention: This experimental treatment will give patients a genetically modified T-cell protein that helps attack cancer cells. They will be measuring the number of adverse events as well as how useful + long-lasting this therapy is. The researchers estimate that the trial will last over 3.5 years.

Can I consider participating?

• Yes: patients with gastric cancer, whose cells express a specific protein (HLA-A2*) and whose tumor cells express the the MAGE-A4 protein. Their life expectancy needs to be at least 6 months.
• No: patients whose cells do not express the correct surface protein, patients who have a current infection
• *Note: HLA-type is determined by a blood test. Please consult your doctor for more information about this test.

ACTIVE, no longer recruiting:

• Toronto – Princess Margaret Cancer Centre (Dr. Albiruni Razak: 416-586-5371)

ID Number: NCT02554812

Link:

• ClinicalTrials.gov
• Canadian Cancer Trials

Description: This is a Phase II trial. It is looking at the effects of the drug Avelumab combined with other cancer therapies for treating advanced gastric tumors. There are many treatment groups in this trial, because the researchers are interested in testing various dosages of each drug, as well as different combinations. The drug combinations they will be testing are:

• A: Avelumab and Utomilumab
• B: Avelumab and PF-04518600
• C: Avelumab and PD-0360324
• D: Avelumab, Utomilumab and PF-04518600

Intervention: All of the medications involved in this trial are immunotherapeutic. They help our immune system’s T cells recognize and attack tumor cells. This trial is trying to understand the effects of the drugs in combination with each other, as well as determine the appropriate dose for each medication.

Can I consider participating?

• Yes: patients with an advanced gastric tumor who have a life expectancy of at least 3 months. The tumor has not been treated with radiation or systemic chemotherapy within 1 year.
• No: patients who are currently having immunotherapy, recently had surgery (within 4 weeks), current infection

Recruiting location in Ontario:

• Hamilton – Hamilton Health Sciences (Dr. Pablo Serrano, via Marlie Valencia: 905-521-2100, Ext. 43921)

ID Number: NCT03445260

Link:

• ClinicalTrials.gov
• Canadian Cancer Trials

Description: This study is looking to understand the potential benefits of nutritional supplements for gastric cancer patients around the time of their surgery. Patients will either receive a nutritional supplement or a placebo. PROGRESS is a relatively small trial called a “feasibility” study. This means the results of this study will help to determine if a larger randomized trials should be created in the future to make more definite conclusions about the usefulness of nutritional supplements for gastric cancer patients.

Intervention: The nutritional supplements being tested in this study are:

• Immunomodulation: a liquid diet which includes a lot of basic biomolecules which form the building blocks of our cells (arginine, RNA, omega-6 fatty acids) (name: INergy FLD)
• Carbohydrate Loading: a sugar-based supplement given before surgery (name: PreCovery)
• Protein Isolate: a protein supplement given before surgery (name: ISOlution)

Can I consider participating?

• Yes: adult patients with gastric cancer who are having surgery
• No: patients with digestive disorders, patients with diabetes, organ failure, or those who cannot tolerate food orally

Publications: Perioperative Optimization With Nutritional Supplements in Patients Undergoing Gastrointestinal Surgery for Cancer (PROGRESS): Protocol for a Feasibility Randomized Controlled Trial

NO LONGER Recruiting – active location in Ontario:

• Hamilton – Juravinski Cancer Centre (contact: 416-480-4270)
• Toronto – Princess Margaret Cancer Centre (contact: 416-946-6508)
• Toronto – Sunnybrook Health Sciences Centre (contact: 416-480-4662)

ID Number: NCT03797326

Links:

• Clinical Trials.gov
• Canadian Cancer Trials

Description:This study is looking at the safety and effectiveness of combination therapy with pembrolizumab (MK-3475) and lenvatinib (E7080/Mk-7902).

Group A: Pembrolizumab and lenvatinib

Intervention: Pembrolizumab is an immunotherapy drug that will help immune system cells to attack and get rid of cancer cells. Lenvatinib is a targeted chemotherapy drug that is a tyrosine kinase inhibitor. It slows down or stops the growth of cancer cells.

Can I consider participating?

• YES:  patients who have a metastatic and/or unresectable solid tumor that is uncurable, has received 2 prior lines of therapy
• NO: patients who have gastrointestinal condition, active infection or autoimmune disease

Actively Recruiting in Hamilton (Juravinski Site; contact Study Coordinator: 905-387-9495)

ID: NCT04662710

Links:

Canada Cancer Trials

ClinicalTrials.gov

Description: This is a phase 3 study that looks at the efficacy and safety of combined treatment of lenvatinib, pembrolizuma, and chemotherapy compared the treatment of chemotherapy alone in patients with advanced gastroesophageal cancer.

Group 1: Lenvatinib, Pembrolizumab and Chemotherapy (CAPOX or mFOLFOX6) 

Group 2: Chemotherapy (Capox or mFOLFOX6)

Intervention: Lenvatinib is a targeted chemotherapy drug that specifically inhibits tyrosine kinase receptors and slows down tumour growth. Pembrolizumab is an immunotherapeutic that helps the immune system, specifically T-cells, to fight cancer cells. 

Can I consider participating?

• Yes: adult patients with advanced unresectable/metastatic gastroesophageal cancer who have not undergone treatment and not HER-2 positive
• No: patients who have undergone previous treatment, cancer in the central nervous system, poor heart conditions, active autoimmune disease, history of hepatitis B or C, and severe weight loss.

Recruiting location in Ontario:

• Ottawa – The Ottawa Hospital Cancer Centre (PI: Dr. Rachel Goodwin, 613-737-7700 Ext. 70166)
• Toronto – Princess Margaret Cancer Centre (PI: Dr. Philippe Bedard, 416-946-4534)

ID Number: NCT03821233

Links:

• Clinical Trials.gov
• Canadian Cancer Trials

Description: This study is looking to determine the maximum-tolerated dose for ZW49. All patients will receive the drug ZW49 with the dose increasing periodically.

Intervention:ZW49 is an immunotherapy drug that helps the immune system target and attack cancer cells.

Can I consider participating?

• YES:  patients who have a HER2-expressing locally advanced (unresectable) and/or metastatic disease
• NO: patients who have history of myocardial infarction or unstable angina, previous treatment with ZW25

Recruiting location in Ontario:

• Ottawa – The Ottawa Hospital Cancer Centre (PI: Dr. Rachel Goodwin, 613-737-7700 Ext. 70166)
• Toronto – Princess Margaret Cancer Centre (PI: Dr. Elena Elimova, 416-946-4501 Ext. 2520)

ID Number: NCT02892123

Links:

• Clinical Trials.gov
• Canadian Cancer Trials

Description: This study is looking the safety and effectiveness of ZW25 on its own and in combination with chemotherapy agents.

Group A: ZW25 and paclitaxel

Group B: ZW25 and capecitabine

Group C: ZW25 and vinorelbine

Intervention: ZW25 is an immunotherapy drug that helps the body’s immune system to attack and fight off the cancer cells. Paclitaxel, capecitabine, and vinorelbine are chemotherapy drugs that target cancer cells.

Can I consider participating?

• YES:  patients who have a HER2-expressing locally advanced (unresectable) and/or metastatic disease
• NO: patients who have untreated brain metastases, acute or chronic uncontrolled renal disease, pancreatitis or liver disease

Recruiting location in Ontario:

• Ottawa – The Ottawa Hospital Cancer Centre (PI: Dr. Rachel Goodwin, 613-737-7700 Ext. 70166)

ID Number: NCT03929666

Links:

• Clinical Trials.gov
• Canadian Cancer Trials

Description:

This study is looking at the effectiveness and tolerability of the ZW25 with a combination of chemotherapy drugs.

Group A: ZW25 and capecitabine and cisplatin

Group B: ZW25 and cisplatin and fluorouracil and leucovorin

Group C: ZW25 and fluorouracil and leucovorin and oxaliplatin

Group D: ZW25 and capecitabine and oxaliplatin .

Intervention: ZW25 is an immunotherapy drug that helps the body’s immune system to attack and fight off the cancer cells. Capecitabine, cisplatin, fluorouracil, leucovorin, and oxaliplatin are chemotherapy drugs that target the cancer cells.

Can I consider participating?

• YES:  patients who have an unresectable, locally advanced, recurrent or metastatic HER2-expresssing tumor
• NO: patients who have a history of treatment with HER2-targeted agent, cardiac disease

Recruiting location in Ontario:

• Toronto – Princess Margaret Cancer Centre 

ID Number: NCT02935634

Link:

• ClinicalTrials.gov

Description: This study is trying to understand the best way to use the drug Nivolumab in a combination with other immunotherapeutic treatments in patients with advanced gastric cancer. There will be three groups in this trial. Each one will compare a different combination of medication:

• Group A – Nivolumab and Ipilimumab
• Group B – Nivolumb and Relatlimab
• Group C – Nivolumab and BMS-986205

Intervention:

• Nivolumab is a drug which helps your immune system (T cells) attack cancerous cells. It is an immunotherapy medication.
• Ipilimumab, Relatlimab and BMS-986205 are also immunotherapy medication

Can I consider participating?

• Yes: patients who have advanced gastric cancer
• No: patients with a HER2+ tumor who have not been treated with trastuzumab, patients with an autoimmune disorder.

Actively Recruiting at Princess Margaret Cancer Centre, Toronto, ON (contact: Dr. Albiruni Razak, 647-970-9845)

ID Number: NCT03069469

Links:

Canadian Cancer Trials 

ClinicalTrials.gov

Description: This is a 2-part study which looks at the safety and efficacy (efficacy = how helpful a drug is in a controlled, experimental setting) of a new medication called DCC-3014. Patients with various different types of cancer may be able to participate. The investigators want to know what the maximum safe dose of the medication is and if it causes any side effects, as well as how good it is at treating the cancer. All patients will receive the medication.

Intervention: DCC-3014 is an orally-administered drug which works to help the immune system find and destroy cancer cells. 

Can I consider participating?

• Yes: adult patients with ADVANCED gastric cancer, able to provide a tumour sample and not a candidate for surgery
• No: having recently taken other experimental cancer medications, pregnancy, brain or spinal cord metastases, cardiovascular disease

Actively Recruiting in Ottawa (The Ottawa Hospital, contact Dr. Rebecca Auer at 613-737-7700)

ID Number: NCT02998736

Links:

Canada Cancer Trials

ClinicalTrials.gov 

Description: The purpose of this study is to learn whether patients undergoing surgery for abdominal cancers would benefit from receiving Cialis 5 days before surgery, Cialis + the flu vaccine on the day of surgery and Cialis again 10 days after surgery. All patients enrolled will receive these medications. The investigators want to know if this intervention can reduce the number of cancer cells which stay in the body after surgery. 

Intervention: Cialis is a medication which is commonly used to treat erectile dysfunction. It does this by affecting cell signalling pathways. It may also play a role in the functioning of some cells of the immune system, including Natural Killer (NK) cells. This trial is based on the hypothesis that Cialis can help these NK cells remain active after surgery to find and kill cancer cells. 

Can I consider participating?

• Yes: patients with stomach cancer (or another abdominal cancer) who are scheduled to have surgery; patients must have a certain level of immune system function and agree to avoid pregnancy around the time of the trial
• No: patients who have had chemotherapy or radiation therapy within 8 weeks of surgery, patients who are pregnant, those with a number of other comorbidities

Actively Recruiting in London (London Health Sciences Centre, contact Dr. Michael Sanatani at 519-685-8640)

Links: 

Canada Cancer Trials 

Description: The purpose of this study is to learn about how cancer patients feel about receiving chemotherapy and how people can be better supported to make decisions regarding their cancer care. Patients will respond to questionnaires about their satisfaction with their healthcare and challenges they have experienced with making treatment decisions. 

Can I consider participating?

• Yes: cancer patients who have undergone treatment with chemotherapy medications at some point more than 2 weeks before the trial starts

• No: patients who are actively dying, enlisted in another clinical trial or unable to give informed consent (i.e.: experiencing delirium or encephalopathy)

Actively Recruiting in Hamilton (Hamilton Health Sciences, Juravinski Cancer Centre; contact Marlie Valencia at 905-521-2100, ext. 43921)

ID Number: NCT03445260

Links:

Canada Cancer Trials

ClinicalTrials.gov 

Description: This study wants to know if giving cancer patients who are having surgery a particular diet around the time of their operation is helpful. Patients will be randomized to one of two groups:

• Group A: will receive a specialized nutritional supplement routine (a drink) starting 30 days before surgery and until 5 days after surgery
• Group B: will receive a placebo solution to drink during the same period of time

This is a randomized, blinded trial. This means that ½ of included patients will receive the intervention (group A) and patients will not know which group they are a part of. The main goal of the study is to determine feasibility, meaning whether or not it is possible to even conduct a study of this nature at a large cancer centre. Investigators will also look at any differences in outcomes or complications of surgery between the two groups. 

Intervention: The nutritional supplement drink routine has 3 parts. A protein supplement drink is taken 3 times per day for a month before surgery; a carbohydrate (sugar) drink is taken the days before and the day of surgery and a mixed-nutrient drink is taken 5 days after surgery. 

Can I consider participating?

• Yes: adult stomach cancer patients who are undergoing surgery.
• No: patients who have malabsorption syndrome, cannot tolerate oral intake, take steroids, have been diagnosed with diabetes or organ failure

Actively Recruiting in Toronto at Mount Sinai Hospital and University Health Network hospitals; contact Emily Taylor at 416-586-4800, ext. 4990

ID: NCT03502317

Links:

Canada Cancer Trials

ClinicalTrials.gov

Description: The purpose of this study is to determine whether prescribed physical and psychological prehabilitation before surgery improves quality of life and other health outcomes for gastrointestinal cancer patients. This is a randomized trial. Half of the patients will receive special instructions for physical activity, mindfulness and self-care for the months before surgery (prehabilitation group). The other half of the patients will not and will prepare themselves for surgery (the usual care group). All patients will be given an activity monitor to log their physical activity. They will fill out questionnaires for 6 months, 3 months and 1 month before and after surgery. 

Intervention: The prehabilitation group will be given a personalized home exercise routine to do as well as mindfulness coaching to help them learn to meditate for 20 minutes twice a day. 

Can I consider participating?

• Yes: adult gastrointestinal cancer patients who speak English and will be able to follow through with the prescribed prehabilitation routines.
• No: patients with certain activity limitations or comorbidities who are unable to participate in the physical/mental exercise routines

Actively Recruiting in Kitchener (Grand River Regional Cancer Centre, contact Carla Girolametto at 519-749-4370, ext. 2307)

ID: NCT03362177

Links:

Canada Cancer Trials

ClinicalTrials.gov

Description: The purpose of this study is to determine whether a medication called Romiplostim is helpful at treating thrombocytopenia (low platelets in the blood) that patients may develop from chemotherapy cancer treatment. 

Intervention: Romiplostim is a drug known as a thrombopoiesis-stimulating agent, meaning that it prompts the body to produce platelets. Platelets are an important component of blood which help to form clots and stop excessive bleeding. 

Can I consider participating?

• Yes: patients who have stomach (or other gastrointestinal) cancer and have been receiving a chemotherapy routine of FOLFOX (including 5-FU and Oxaliplatin chemotherapy) for at least 2 weeks, and have a low platelet count in their blood
• No:  patients with any blood cancer, breast/cervical cancers, or a number of other comorbidities