Your session is about to expire
← Back to Search
Tyrosine Kinase Inhibitor
Sunitinib for Thymoma
Phase 2
Waitlist Available
Led By Arun Rajan, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months after initiation of treatment
Awards & highlights
Study Summary
This trial is testing the safety and effectiveness of sunitinib as a treatment for advanced thymus cancer. Eligible participants must be at least 18 years old and have had at least one previous chemotherapy treatment containing platinum. Sunitinib will be taken once daily for 4 weeks, followed by 2 weeks of rest. This 6-week period will be repeated as long as the tumor does not continue to grow and there are no severe side effects.
Who is the study for?
Adults with advanced thymus cancer that hasn't improved after platinum-based chemotherapy can join. They must have measurable disease, be able to consent, and use birth control if needed. Excluded are those with severe diseases, recent other cancer treatments, certain heart or blood pressure issues, inability to swallow pills, HIV without a good CD4 count, pregnant women, or a history of similar drug reactions.Check my eligibility
What is being tested?
The trial is testing Sunitinib's safety and effectiveness for advanced thymus cancer post-chemotherapy. Participants take Sunitinib daily for 4 weeks followed by a 2-week break (a cycle), repeating cycles unless the tumor grows or side effects become severe.See study design
What are the potential side effects?
Sunitinib may cause fatigue, high blood pressure, bleeding problems, digestive issues like nausea or diarrhea; hand-foot syndrome; skin discoloration; mouth sores; altered taste sensation; coughing up blood; and in rare cases heart problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months after initiation of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months after initiation of treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants With an Objective Response (Partial Response (PR) + Complete Response (CR) for Sunitinib in Participants With Relapsed or Refractory Thymoma or Thymic Carcinoma
Secondary outcome measures
Number of Grades ≥3 Adverse Events Related to Sunitinib
Number of Participants Alive at 1 Year After Treatment With Sunitinib
Progression-free Survival for Sunitinib in Participants With Relapsed or Refractory Thymoma or Thymic Carcinoma
Other outcome measures
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0).
Side effects data
From 2019 Phase 2 trial • 305 Patients • NCT0198424246%
Proteinuria
41%
Fatigue
37%
Arthralgia
30%
Cough
30%
Nausea
28%
Diarrhoea
28%
Epistaxis
26%
Rash
26%
Hypertension
22%
Abdominal pain
22%
Blood creatinine increased
20%
Musculoskeletal pain
20%
Pain in extremity
20%
Constipation
20%
Dysphonia
17%
Oedema peripheral
17%
Pruritus
17%
Upper respiratory tract infection
17%
Back pain
17%
Hypothyroidism
17%
Dyspnoea
15%
Headache
13%
Stomatitis
13%
Vomiting
13%
Mucosal inflammation
13%
Oropharyngeal pain
13%
Pyrexia
11%
Abdominal distension
11%
Hyperglycaemia
11%
Hyponatraemia
11%
Productive cough
11%
Dry mouth
11%
Nasal congestion
11%
Dry skin
9%
Haematuria
9%
Dizziness
9%
Chest pain
9%
Sinusitis
9%
Hypophosphataemia
9%
Hyperkalaemia
9%
Muscle spasms
9%
Night sweats
9%
Decreased appetite
7%
Flank pain
7%
Adrenal insufficiency
7%
Gingival bleeding
7%
Myalgia
7%
Neck pain
7%
Dyspepsia
7%
Blood lactate dehydrogenase increased
7%
Dehydration
7%
Hypoalbuminaemia
7%
Insomnia
7%
Acute kidney injury
7%
Nocturia
7%
Dyspnoea exertional
7%
Rhinorrhoea
7%
Haemorrhoids
7%
Pneumonia
7%
Tumour pain
7%
Rash erythematous
7%
Ecchymosis
7%
Platelet count decreased
7%
Protein total increased
7%
Contusion
7%
Dry eye
4%
Thrombocytopenia
4%
Anaemia
4%
Hypomagnesaemia
4%
Depression
4%
Weight decreased
2%
Pancreatitis acute
2%
Appendicitis
2%
Asthenia
2%
Bronchitis
2%
Muscle haemorrhage
2%
Limb Operation
2%
Embolism
2%
Hypertensive crisis
2%
Oedema
2%
Sepsis
2%
Femur fracture
2%
Paraesthesia
2%
Cardiomyopathy
2%
Urinary tract infection
2%
Diverticulitis
2%
Atrial fibrillation
2%
Anxiety
100%
80%
60%
40%
20%
0%
Study treatment Arm
Atezolizumab (Crossover)
Atezolizumab and Bevacizumab
Atezolizumab
Sunitinib
Sunitinib (Crossover)
Trial Design
2Treatment groups
Experimental Treatment
Group I: Group 2 (Thymic carcinoma only)Experimental Treatment1 Intervention
Group 2 (Thymic carcinoma only) treated with sunitinib 50 mg/day, 2 weeks on, 1 week off (3 week cycle).
Group II: Group 1 (Thymoma and thymic carcinoma)Experimental Treatment1 Intervention
Group 1 (Thymoma and thymic carcinoma) treated with sunitinib 50 mg/day, 4 weeks on, 2-weeks off (6 week cycle).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sunitinib
2014
Completed Phase 3
~4380
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,717 Previous Clinical Trials
40,953,307 Total Patients Enrolled
22 Trials studying Thymoma
2,697 Patients Enrolled for Thymoma
Indiana University School of MedicineOTHER
185 Previous Clinical Trials
142,737 Total Patients Enrolled
2 Trials studying Thymoma
29 Patients Enrolled for Thymoma
Arun Rajan, M.D.Principal InvestigatorNational Cancer Institute (NCI)
15 Previous Clinical Trials
3,680 Total Patients Enrolled
6 Trials studying Thymoma
868 Patients Enrolled for Thymoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your hemoglobin levels should be at least 9 grams per deciliter (g/dL) or higher.You have a measurable tumor that can be evaluated using a specific set of criteria called RECIST 1.1.Your white blood cell count is at least 3,000 per microliter.You are currently participating in another study for an experimental treatment.You must have a confirmed diagnosis of thymoma or thymic carcinoma from a qualified pathology department.You need to be physically able to take care of yourself and do your normal daily activities without help most of the time.You are expected to live for at least three more months.You are expected to live for at least three more months.You have cancer that has spread to your brain and is causing symptoms.You must be 18 years old or older to participate.You cannot have had chemotherapy, radiation therapy, or a major surgery within the 4 weeks before starting the trial.Your body has a minimum amount of infection-fighting white blood cells called neutrophils.You had cancer that required treatment within the past 5 years, except for non-melanoma skin cancer, thyroid papillary carcinoma or early-stage cervical cancer that was treated successfully.You have already received chemotherapy treatment or have chosen not to receive it. Your cancer has continued to progress despite this treatment.Your cancer is treatable with potentially curative therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Group 2 (Thymic carcinoma only)
- Group 2: Group 1 (Thymoma and thymic carcinoma)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger