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Kinase Inhibitor
Sunitinib for Kidney Cancer
Phase 2
Waitlist Available
Led By Lionel D Lewis, MD
Research Sponsored by Dartmouth-Hitchcock Medical Center
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 every 12 weeks from randomization until progression, estimated time frame is 18 months
Awards & highlights
Study Summary
This trial is testing whether two different drugs that treat kidney cancer, sunitinib and temsirolimus, are more effective when given sequentially than when given separately.
Eligible Conditions
- Kidney Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 12 weeks from randomization until progression, estimated time frame is 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 12 weeks from randomization until progression, estimated time frame is 18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression Free Survival
Secondary outcome measures
Clinical Response Rate as Measured by Best Response Achieved
To Characterize the Toxicity Profile
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%
Adrenal insufficiency
7%
Gingival bleeding
7%
Flank pain
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
1Treatment groups
Experimental Treatment
Group I: Alternating Sunitinib and TemsirolimusExperimental Treatment2 Interventions
A cycle is defined as:
Sunitinib 50mg by mouth daily for 4 weeks followed by a two week rest Temsirolimus 25mg IV weekly for 4 weeks followed by a two week rest
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sunitinib
2014
Completed Phase 3
~4380
Temsirolimus
2008
Completed Phase 2
~1940
Find a Location
Who is running the clinical trial?
Dartmouth-Hitchcock Medical CenterLead Sponsor
524 Previous Clinical Trials
2,543,302 Total Patients Enrolled
Lionel D Lewis, MDPrincipal InvestigatorDartmouth-Hitchcock Medical Center
2 Previous Clinical Trials
6 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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