← Back to Search

Tyrosine Kinase Inhibitor

Pre-Surgical Sutent for Kidney Cancer

Q: What health concerns is Sunitinib typically prescribed to address?

Sunitinib is medically approved to treat <a href="https://www.withpower.com/clinical-trials/soft-tissue-sarcoma">soft tissue sarcoma</a> (STS) as well as gastrointestinal stromal tumors, metastatic pancreatic neuroendocrine tumors, and advanced <a href="https://www.withpower.com/clinical-trials/renal-cell-carcinoma">renal cell carcinoma</a> (ARCC).

Q: Has the FDA granted authorization for Sunitinib to be used therapeutically?

There is limited evidence confirming Sunitinib's safety, leading to an assessment of 2 on the 1-3 scale. However, no data exists currently that supports its efficacy.

Q: What previous investigations have been conducted involving Sunitinib?

Currently, 34 studies are underway exploring Sunitinib. Of those trials, 11 have progressed to Phase 3. Tampa, <a href="https://www.withpower.com/clinical-trials/florida">Florida</a> is the primary hub for research into this drug; however there are 3860 other sites around the world conducting clinical trials for it.

Q: Is the enrollment period of this trial still in effect?

Unfortunately, this trial has already reached its recruitment stage. Initially posted on June 24th 2008 and edited lastly on October 11th 2022, it is no longer recruiting participants. However, if you are still looking to participate in a study, there are 2582 studies currently accepting enrolment for carcinoma cases and 34 trials involving Sunitinib that require volunteers.

Q: What is the current participate count for this medical experiment?

This trial is presently closed to recruitment, with its first post date on June 24th 2008 and final update October 11th 2022. For those searching for additional studies related to carcinoma, there are 2582 trials that remain open; alternatively, 34 separate Sunitinib-related clinical trials are actively looking for participants.

Phase 2

Waitlist Available

Led By Eric Jonasch, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with histologically or cytologically confirmed metastatic clear cell RCC who are eligible for cytoreductive nephrectomy

Patients must have adequate organ and marrow function within 14 days as defined below: a) absolute neutrophil count >/= 1,500/microL b) platelets >/= 75,000/microL c) Hgb > 9.0 g/dL (may be transfused or receive epoetin alfa [e.g., Epogen®] to maintain this level) d) total bilirubin </= 2.0 mg/dl e) serum creatinine </= 1.5 times the upper limit of normal (ULN) f) AST(SGOT) and/or ALT (SGPT) </= 2.5 X institutional ULN for subjects without evidence of liver metastases g) AST(SGOT) and/or ALT (SGPT) </= 5 X institutional ULN for subjects with documented liver metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline start of treatment to disease progression; up to 5 years

Awards & highlights

Study Summary

This trial will test if Sutent can help control renal cell carcinoma before surgery, as well as study the safety of sunitinib malate.

Who is the study for?

This trial is for adults with metastatic clear cell renal cell carcinoma who are fit for surgery to remove a kidney. They must be in good physical condition, not pregnant, and willing to use birth control. People with recent surgeries, other cancers within 2 years (except certain skin or in situ carcinomas), brain tumors or metastases, uncontrolled blood pressure, serious heart conditions, or those on certain other treatments can't join.Check my eligibility

What is being tested?

The study tests if taking Sutent (sunitinib malate) before kidney removal surgery can help manage kidney cancer better. It's also looking at how safe sunitinib malate is when used this way.See study design

What are the potential side effects?

Sutent may cause side effects like fatigue, high blood pressure, bleeding issues, digestive problems such as nausea and diarrhea, mouth sores, hand-foot syndrome (redness and pain on palms or soles), low blood counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have metastatic clear cell kidney cancer and am eligible for surgery to remove my kidney.

Select...

Your blood and organ functions must be within normal ranges, including specific levels for white blood cells, platelets, hemoglobin, bilirubin, creatinine, and liver enzymes.

Select...

I have a tumor that can be measured and is at least 20 mm in size, or 10 mm if detected by a CT scan.

Select...

I am fully active and can carry on all my pre-disease activities without restriction.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline start of treatment to disease progression; up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline start of treatment to disease progression; up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline start of treatment to disease progression; up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time to progression (TTP)

Toxicity of Sunitinib in Patients With Metastatic Renal Cell Carcinoma (RCC)

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

Haematuria

Dizziness

Chest pain

Sinusitis

Hypophosphataemia

Hyperkalaemia

Muscle spasms

Night sweats

Decreased appetite

Adrenal insufficiency

Gingival bleeding

Flank pain

Myalgia

Neck pain

Dyspepsia

Blood lactate dehydrogenase increased

Dehydration

Hypoalbuminaemia

Insomnia

Acute kidney injury

Nocturia

Dyspnoea exertional

Rhinorrhoea

Haemorrhoids

Pneumonia

Tumour pain

Rash erythematous

Ecchymosis

Platelet count decreased

Protein total increased

Contusion

Dry eye

Thrombocytopenia

Anaemia

Hypomagnesaemia

Depression

Weight decreased

Pancreatitis acute

Appendicitis

Asthenia

Bronchitis

Muscle haemorrhage

Limb Operation

Embolism

Hypertensive crisis

Oedema

Sepsis

Femur fracture

Paraesthesia

Cardiomyopathy

Urinary tract infection

Diverticulitis

Atrial fibrillation

Anxiety

100%

80%

60%

40%

20%

Study treatment Arm

Atezolizumab (Crossover)

Atezolizumab and Bevacizumab

Atezolizumab

Sunitinib

Sunitinib (Crossover)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Sunitinib + NephrectomyExperimental Treatment2 Interventions

Sunitinib 50 mg by mouth daily for 28 consecutive days. Nephrectomy will occur approximately 24 hours after the last dose of sunitinib.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sunitinib

2014

Completed Phase 3

~4380

Nephrectomy

2013

Completed Phase 3

~1430

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

PfizerIndustry Sponsor

4,567 Previous Clinical Trials

10,911,823 Total Patients Enrolled

M.D. Anderson Cancer CenterLead Sponsor

2,966 Previous Clinical Trials

1,804,731 Total Patients Enrolled

Eric Jonasch, MDPrincipal InvestigatorM.D. Anderson Cancer Center

9 Previous Clinical Trials

402 Total Patients Enrolled

Media Library

Sunitinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT00715442 — Phase 2

Kidney Cancer Research Study Groups: Sunitinib + Nephrectomy

Kidney Cancer Clinical Trial 2023: Sunitinib Highlights & Side Effects. Trial Name: NCT00715442 — Phase 2

Sunitinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00715442 — Phase 2

Frequently Asked Questions

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

What health concerns is Sunitinib typically prescribed to address?

"Sunitinib is medically approved to treat soft tissue sarcoma (STS) as well as gastrointestinal stromal tumors, metastatic pancreatic neuroendocrine tumors, and advanced renal cell carcinoma (ARCC)."

Answered by AI

Has the FDA granted authorization for Sunitinib to be used therapeutically?

"There is limited evidence confirming Sunitinib's safety, leading to an assessment of 2 on the 1-3 scale. However, no data exists currently that supports its efficacy."

Answered by AI

What previous investigations have been conducted involving Sunitinib?

"Currently, 34 studies are underway exploring Sunitinib. Of those trials, 11 have progressed to Phase 3. Tampa, Florida is the primary hub for research into this drug; however there are 3860 other sites around the world conducting clinical trials for it."

Answered by AI

Is the enrollment period of this trial still in effect?

"Unfortunately, this trial has already reached its recruitment stage. Initially posted on June 24th 2008 and edited lastly on October 11th 2022, it is no longer recruiting participants. However, if you are still looking to participate in a study, there are 2582 studies currently accepting enrolment for carcinoma cases and 34 trials involving Sunitinib that require volunteers."

Answered by AI

What is the current participate count for this medical experiment?

"This trial is presently closed to recruitment, with its first post date on June 24th 2008 and final update October 11th 2022. For those searching for additional studies related to carcinoma, there are 2582 trials that remain open; alternatively, 34 separate Sunitinib-related clinical trials are actively looking for participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pre-Surgical Sutent in Renal Cell Carcinoma (RCC)

2008. "Pre-Surgical Sutent in Renal Cell Carcinoma (RCC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00715442.

All > Basal Cell Carcinoma > Sutent