Find a Clinical Trial - United States

Osteosarcoma|Osteosarcoma In Children

Cabometyx|Cometriq

Canada

Denmark

France

Germany

Finland

Australia

Italy

Netherlands (Kingdom of the)

Austria

Israel

Ireland

United States of America (the)

United Kingdom of Great Britain and Northern Ireland (the)

Sweden

Switzerland

Poland

Belgium

Spain

Not Yet Recruiting

A study to assess whether adding maintenance cabozantinib (XL184) to best supportive care helps children, adolescents and young adults with osteosarcoma.

The participants of this study will be children, adolescents, and young adults with residual osteosarcoma, which cannot be removed completely through surgery. Participants will have achieved a partial response or stable disease at the end of conventional chemotherapy. Osteosarcoma is cancer of the bone. The cancer cells make immature bone cells, known as osteoid. Osteosarcoma is very rare, but it is the most common type of bone cancer in children and teens. It is most common in teens and young adults. In this study, participants will receive either cabozantinib and best supportive care or the best supportive care alone. Best supportive care will be provided at the investigator’s discretion and according to institutional guidelines. It includes antibiotics, nutritional support, correction of metabolic disorders, optimal symptom control and pain management (including radiotherapy), etc. but does not include tumor specific therapy. Cabozantinib will be taken by mouth (orally), as a tablet, once a day. Cabozantinib will be provided to participants who tolerate it for as long as their disease does not progress. Participants in the study receiving best supportive care alone may switch to treatment with cabozantinib and best supportive care if their disease progresses and if other eligibility criteria are met. Participants may withdraw consent to participate at any time. The estimated duration of the study for participants is 24 months, however a participant could remain in the study longer if demonstrating treatment benefit.

Follicular Lymphoma

Refractory Follicular Lymphoma

Tazverik

United States of America (the)

Not Yet Recruiting

A study to assess efficacy and safety of oral tazemetostat in adult participants with relapsed/refractory follicular lymphoma that does not have an “EZH2 gain-of-function” genetic mutation

The purpose of this research study is to learn about the effectiveness and safety of the study drug, tazemetostat, in adults with relapsed/refractory follicular lymphoma whose tumours do not have an “EZH2” genetic mutation. Follicular lymphoma is a blood cancer. It affects white blood cells called lymphocytes. White blood cells normally help to fight infections, but when you have follicular lymphoma, the blood cells can form tumours in your body. ‘Relapsed/refractory’ follicular lymphoma means the disease has either not improved or is getting worse (progressing) during or after previous treatment. Tazemetostat already has approval in the United States for the treatment of adult patients with relapsed/refractory follicular lymphoma with or without the “EZH2” mutation who have no satisfactory alternative treatment options. This study is being conducted to better understand the effectiveness in patients whose tumours do not have an “EZH2” genetic mutation and who previously received therapies commonly used in the U.S. in your body. ‘Relapsed/refractory’ follicular lymphoma means the disease has either not improved or is getting worse (progressing) during or after previous – 5 – SM D form protocol master data -INT / Version 1 treatment. Tazemetostat already has approval in the United States for the treatment of adult patients with relapsed/refractory follicular lymphoma with or without the “EZH2” mutation who have no satisfactory alternative treatment options. This study is being conducted to better understand the effectiveness in patients whose tumours do not have an “EZH2” genetic mutation and who previously received therapies commonly used in the U.S. In this study, all participants will receive the study drug. It will be taken by mouth (orally), as a tablet, twice daily. The sizes and number of tumours according to scan results will be collected as well as results of safety tests (such as physical examinations and laboratory tests). The study consists of 3 or 4 periods: ? Screening period may take up to 4 weeks and require at least 1 visit. ? Treatment period will require 2 visits for each of the first 2 months, followed by 1 visit every month for the remainder of the first 6 months, followed by 1 visit every 3 months (except for women of childbearing potential [WOCBP], who will continue to have a visit every month) until unacceptable toxicity, disease progression, or the start of new systemic anticancer therapy, whichever is first. ? Safety follow -up period will last for 1 month after the last dose of tazemetostat, and it will end with 1 visit or telephone call. ? Long -term follow -up period is only for participants who stop taking tazemetostat while their disease continues to respond; this period will last until disease progression, start of new cancer treatment, or death from any cause, whichever is first. Tazemetostat will be provided to participants who tolerate it for as long as their disease does not progress. Participants may be transferred to another study or program after about 2 years for continued treatment with tazemetostat or for long-term follow-up. Patients may withdraw consent to participate at any time.

Colorectal Cancer

Head And Neck Squamous Cell Carcinoma

Melanoma

Pancreatic Ductal Adenocarcinoma

Solid Tumor

IPN01194

United States of America (the)

Recruiting

A Study to Assess IPN01194 When Administered Alone in Adults With Advanced Solid Tumours

The purpose of this study is to determine the appropriate dosage, safety and effectiveness of the study drug, IPN01194 in adults with advanced solid tumours. The participants in this study will have advanced solid tumours. ‘Advanced solid tumours’ refers to cancers that can occur in several places, including cancers in organs or tissues that have spread from their original site to nearby tissues or other parts of the body. In this study, all participants will receive the study drug, which will be taken by mouth (orally). Detailed Description: The study consists of two parts, called Phase I and Phase IIa. Phase I is designed to assess the safety of increasing doses of IPN01194 in participants with specific types of advanced solid tumours. The aim of this “dose escalation” phase is to find the dose range showing activity on the tumor that can be tolerated by the participants, and to determine the two doses for further testing in Phase IIa. Phase I will assess how the body processes and responds to the study drug when administered with and without food. In Phase IIa, participants with selected single tumour type will be invited to take part. During this phase, the two dose levels of the study drug identified from Phase I will be tested. Participants will take the study drug one of the two dose levels. Each participant will be assigned to a dose level at random (by chance). Each phase will consist of three periods: 1- A period to assess eligibility (screening period) that will take up to 28 days. 2- A treatment period of at least 28 days that will require at least two visits for the first month followed by one visit every month. There will be also one visit, at the end of treatment, at least 30 days after the last administration of study drug. 3- A follow-up period (Phase IIa participants only), where every 3 months, participants will be contacted by phone, until death or the study cut-off date, whichever comes first. Participants will undergo blood samplings, urine collections, physical examinations, and clinical evaluations. They may continue some other medications, but the details need to be recorded. If in the opinion of the investigator a participant is continuing to experience clinical benefit after the cut-off date, the participant may remain in the study and continue to receive the study drug until either disease progression, unacceptable toxicity or other withdrawal criteria are met.

Upper Limb Spasticity

Dysport

United States of America (the)

France

Canada

Recruiting

A Study to Compare the Safety and Efficacy of Dysport® and Botox® in Adults With Upper Limb Spasticity.

This study is aiming to demonstrate the non-inferiority of AbobotulinumtoxinA (aboBoNT-A) versus OnabotulinumtoxinA (onaBoNT-A) as the primary safety endpoint, and the superiority of aboBoNT-A over onaBoNT-A with respect to duration of response as the key secondary efficacy endpoint when used at optimal doses according to approved prescribing information of each product.

Chronic Migraine

Dysport

Canada

Czechia

Germany

Italy

Georgia

United States of America (the)

United Kingdom of Great Britain and Northern Ireland (the)

Poland

Spain

Recruiting

A study to evaluate the effectiveness and safety of Dysport® for the prevention of chronic migraine in adults

The purpose of this study is to understand the safety and effectiveness of the study drug, Dysport® when compared with placebo in preventing chronic migraine. A migraine is a headache with severe throbbing pain or a pulsating sensation, usually on one side of the head, and is often accompanied by feeling or being sick and a sensitivity to bright lights and sound. Chronic Migraine is defined as having at least 15 days of headache a month with at least 8 of those days being migraine headache days. Migraines are caused by a series of events which cause the brain to get stimulated/activated, which results in the release of chemicals that cause pain. Dysport® is a formulation of Botulinum toxin type A (BoNT-A), a medication that stops the release of these chemical messengers. The study will consist of 2 or 3 periods: 1. A ’screening period’ of 6 to 12 weeks to assess whether the participant can take part to the study and requires 1 visit. 2. A first Treatment Phase of 24 weeks. On Day 1 and at Week 12 of the first Treatment Phase, participants will receive injections into various muscles across the head, neck, face and shoulders. The injections will contain either Dose A or Dose B of Dysport® or a placebo (an inactive substance or treatment that looks the same as, and is given in the same way as, an active drug or intervention/treatment being studied). Participants will make 4 visits to the clinic in person and have 4 remote (online) visits. 3. A second, extension Treatment Phase of 24 weeks. SMD form protocol master data–5- INT / Version 1 In the second Treatment Phase, all participants will get Dysport® (Dose A or Dose B). There will be 3 in person visits and 4 remote visits. Participants will need to complete an e-diary and questionnaires throughout the study. Participants will undergo blood samplings, urine collections, physical examinations, and clinical evaluations. They may continue some other medications, but the details need to be recorded. The total study duration for a participant will be up to 60 weeks (approx. 14 months).