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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
3.1.2 At least one prior line of platinum-based chemotherapy or patient must have refused cytotoxic chemotherapy. Progressive disease must be documented prior to study entry.
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.

Eligible Conditions
  • Thymoma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have already received chemotherapy treatment or have chosen not to receive it. Your cancer has continued to progress despite this treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months after initiation of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months after initiation of treatment for reporting.

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 • NCT01984242
46%
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
13,606 Previous Clinical Trials
40,913,431 Total Patients Enrolled
22 Trials studying Thymoma
2,697 Patients Enrolled for Thymoma
Indiana University School of MedicineOTHER
185 Previous Clinical Trials
142,776 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

Sunitinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01621568 — Phase 2
Thymoma Research Study Groups: Group 2 (Thymic carcinoma only), Group 1 (Thymoma and thymic carcinoma)
Thymoma Clinical Trial 2023: Sunitinib Highlights & Side Effects. Trial Name: NCT01621568 — Phase 2
Sunitinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01621568 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this trial open to new participants?

"This medical trial is currently not enrolling any patients. Initially posted on May 15th 2012, and last updated on May 17th 2022, this study is currently inactive. Nevertheless, there are 36 studies actively recruiting cancer of thymus sufferers and a further 34 trials for Sunitinib accepting participants at the moment."

Answered by AI

How many individuals have opted-in to participate in this clinical trial?

"Unfortunately, this research trial is not presently accepting new applicants. Initially posted on the 15th of May 2012 and last amended on 17th of May 2022, this clinical investigation has been paused for now. However, those in search of alternate studies can consider 36 trials that are admitting patients with thymus cancer or 34 studies recruiting Sunitinib participants."

Answered by AI

Have there been past investigations involving Sunitinib?

"At this moment in time, 11 clinical trials are underway at Phase 3 for Sunitinib. Most of the tests take place near Hannover, Niedersachsen; however, 3860 sites host trialling for Sunitinib around the world."

Answered by AI

Might I be eligible to join this research endeavor?

"This medical trial is seeking 56 patients who have malignant thymus cancer, aged 18 to 100. Those wishing to participate must satisfy the following criteria: leukocytes greater than or equal to 3,000/mcL); prior cytotoxic chemotherapy; measurable disease according to RECIST 1.1; histological confirmation of malignancy by an accredited pathology department; no recent major surgery or radiation therapy; age over 18 years old with a life expectancy exceeding three months, hemoglobin levels higher than 9 g/dL and absolute neutrophil count above 1,200/mcL as well as ECOG performance status lower or equal"

Answered by AI

How is Sunitinib generally employed to help patients?

"Sunitinib is a potent therapeutic option for soft tissue sarcoma (STS), gastrointestinal stromal tumors, and metastatic pancreatic neuroendocrine tumors."

Answered by AI

Is this investigation open to people of advanced age?

"According to the criteria, individuals aged between 18 and 100 years can apply for this clinical trial. Additionally, there are 6 trials designed specifically for minors and 69 that cater to elderly patients."

Answered by AI

Has Sunitinib received the endorsement of the Food and Drug Administration?

"Our team at Power has given Sunitinib a safety score of 2, as there is some existing data in support of its security but none for efficacy."

Answered by AI
Recent research and studies
~4 spots leftby Mar 2025