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Kidney CancerPhase 2NCT01217931

Sequential Two-agent Assessment in Renal Cell Carcinoma Therapy: The START Trial

A Phase 2 study testing Pazopanib, Bevacizumab and Everolimus in people with Kidney Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The goal of this clinical research study is to compare 6 different 2-drug "sequences" of everolimus, bevacizumab, or pazopanib to learn how they may affect metastatic kidney cancer. For the 2-drug sequence, participants will receive 1 of these drugs and may start taking another of these drugs after that. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Kidney Cancer
What is being tested?
Pazopanib, Bevacizumab and Everolimus
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteUnited States
Study dates
19 Jan 2011to 31 Jan 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Confirmed metastatic RCC with a clear cell component.
  • Prior radical or partial nephrectomy required. Patients whose primary tumor was treated with cryoablation or radiofrequency ablation would also be eligible.
  • Measurable disease
  • Age >/= 18 years. Because no dosing or adverse event data are currently available on the use of these targeted agents in patients < 18 years of age, children are excluded from this study
  • ECOG performance status 0 or 1
  • Adequate organ and marrow function within 14 days as defined below: a) Absolute neutrophil count /=> 1,500/microL; b) Platelets >/= 100,000/microL; c) Hgb >/= 9.0 g/dL (transfusion allowed); d) Total bilirubin < 1.5 mg/dl; e) Albumin > 2.5 g/dL; f) AST and ALT </= 2.5 X ULN for subjects without liver metastases; g) AST and ALT < 5 X ULN for subjects with liver metastases; h) Serum creatinine </= 2 mg/dL or CrCl >/= 50 cc/min; i) Fasting serum cholesterol </= 300 mg/dL or </= 7.75 mmol/L and fasting triglycerides </= 2.5 x ULN. NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication.
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  • Female patients of childbearing potential must have a negative pregnancy test (serum/plasma or urine) within 7 days prior to beginning treatment on the study due to the possible teratogenic effect
  • Patients of child fathering or childbearing potential must agree to practice a form of medically acceptable birth control while on study
  • Patients must give written informed consent prior to initiation of study-related procedures. Patients with a history of major psychiatric illness must be judged able to fully understand the investigational nature of the study and the risks associated with the therapy
  • Patients must be able to swallow pills
  • Both men and women and members of all races and ethnic groups are eligible for this trial

Who cannot join

  • No patient with any concurrent active malignancy, i.e. a patient requiring or receiving systemic therapy for another malignancy at the same time of treatment for RCC
  • Patients must not have received any prior targeted therapy (anti-VEGF agents or mTOR inhibitors), including adjuvant therapy, and must not have received any prior chemotherapy for mRCC. However, patients who had received prior immunotherapy, such as cytokines or vaccines, are permitted to enroll.
  • Patients must not be scheduled to receive another experimental drug while on this study. Patients are permitted to receive concomitant bisphosphonates.
  • Patients must not have multiple brain metastases or leptomeningeal disease. Patients with controlled solitary brain metastasis are eligible.
  • Patients must not have had a stroke or transient ischemic attack within 6 months.
  • Patients must not have uncontrolled infections.
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  • Patients must not have clinically significant cardiovascular disease, defined as myocardial infarction (or unstable angina) within 6 months, New York Heart Association (NYHA) Grade II or greater congestive heart failure, serious cardiac dysrhythmia refractory to medical management
  • Patients must not have uncontrolled hypertension, defined as > 140/90 or prior history of hypertensive crisis or hypertensive encephalopathy. Treatment of hypertension with medications is permitted.
  • History of hemoptysis (>/= 1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1
  • Significant vascular disease (e.g., aortic aneurysm, aortic dissection)
  • Symptomatic peripheral vascular disease
  • Pregnant women are excluded from this study because of the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with these agents, breast-feeding should be discontinued if the mother is enrolled on this trial.
  • Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy. Therefore, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with some of these agents.
  • Patients must not have a clinical history of coagulopathy or bleeding diathesis. Patients may be on therapeutic anticoagulation preferably a low-molecular weight heparin. If the patients are on warfarin, the INR should be maintained within a therapeutic level and must be checked weekly for the first four weeks, then every 2 weeks for 4 additional weeks. Thereafter, they may be followed at the discretion of the treating provider. Antiplatelet agents are allowed.
  • Concomitant treatment with rifampin, St. John's wort, or the cytochrome p450 enzyme-inducing antiepileptic drugs (phenytoin, carbamazepine or Phenobarbital) is not allowed on this study.
  • Patients with significant baseline proteinuria defined as 300 or greater by screening U/A will be excluded if they have > 1,000 mg proteins in a 24-hour urine collection or if they have a random urine protein over creatinine (UPC) ratio >1.
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment
  • Serious, non-healing wound, ulcer, or bone fracture
  • Uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN
  • Known hypersensitivity to any component of bevacizumab, pazopanib or everolimus.
  • Patients should not receive immunization with attenuated live vaccines within one week of study entry or during study period. Close contact with those who have received attenuated live vaccines should be avoided during treatment with everolimus. Examples of live vaccines include intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella and TY21a typhoid vaccines.
  • Patients with severely impaired lung function as defined as spirometry and DLCO that is 50% of the normal predicted value and/or 02 saturation that is 88% or less at rest on room air
  • Liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh class C). Note: A detailed assessment of Hepatitis B/C medical history and risk factors must be done at screening for all patients. HBV DNA and HCV RNA PCR testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection.
  • Patients receiving chronic, systemic treatment with steroids in pharmacological doses or immunosuppressive agents are excluded. Patients who receive steroids for physiological replacement, e.g., after adrenalectomy are not excluded. Topical or inhaled corticosteroids are also allowed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

The goal of this clinical research study is to compare 6 different 2-drug "sequences" of everolimus, bevacizumab, or pazopanib to learn how they may affect metastatic kidney cancer. For the 2-drug sequence, participants will receive 1 of these drugs and may start taking another of these drugs after that. Researchers will also study the safety of these 2-drug sequences.

Read the detailed description

The Study Drugs:

Everolimus is designed to block the growth of cancer cells, which may cause cancer cells to die.

Bevacizumab is designed to block the growth of blood vessels that supply nutrients necessary for tumor growth. This may prevent or slow down the growth of cancer cells.

Pazopanib is designed to block a protein that may cause uncontrolled tumor growth. Blocking this protein may prevent cancer from growing and spreading.

Study Drug Administration:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the roll of dice) to 1 of 6 groups. There is an equal chance of being assigned to each group.

  • Group 1 will receive pazopanib, possibly followed by bevacizumab.
  • Group 2 will receive pazopanib, possibly followed by everolimus.
  • Group 3 will receive everolimus, possibly followed by bevacizumab.
  • Group 4 will receive everolimus, possibly followed by pazopanib.
  • Group 5 will receive bevacizumab, possibly followed by pazopanib.
  • Group 6 will receive bevacizumab, possibly followed by everolimus.

If the disease gets worse while you receive your first assigned drug, you will stop taking the drug. Then if you are not having side effects, you will start taking your second assigned drug 2-4 weeks later.

Everolimus is taken by mouth 1 time per day (at about the same time each day).

Bevacizumab is given by vein over 30-90 minutes, 1 time every 2 weeks.

Pazopanib is taken by mouth 1 time per day (at about the same time each day on an empty stomach).

You may be able to receive the bevacizumab doses at your local doctor's office. Ask your study doctor about this.

Study Visits:

Every week during Weeks 1-4, your blood pressure will be checked (either at home, at the clinic, or by your local doctor) if you are taking pazopanib or bevacizumab. If you are checking your own blood pressure at home, you should keep a log to write down your blood pressure. Bring the log to your next clinic visit.

Every 2 weeks, urine will be collected for routine tests if you are receiving bevacizumab.

Every 4 weeks:

  • You will have a physical exam, including measurement of your weight and vital signs.
  • Your performance status will be recorded.
  • You will be asked about any drugs you may be taking.
  • You will be asked about any side effects you may have had.
  • Blood (about 3 tablespoons) will be drawn for routine tests. If you are receiving everolimus, you will fast (have nothing to eat or drink except water) starting the night before these tests. The doctor will discuss this with you.
  • Urine will be collected for routine tests if you are receiving everolimus or pazopanib.

Every 8 weeks, the following tests and procedures will be performed. If you are receiving the study treatment at your local doctor's office, you must return to MD Anderson for these tests and procedures.

  • Blood (about 3 teaspoons) will be drawn for routine tests. If you are receiving pazopanib, this blood will also be used to check your thyroid function.
  • You will have CT scans of the chest and abdomen to check the status of the disease.
  • You will fill out 5 questionnaires about the quality of your life and about how you are feeling. This should take about 30 minutes.

Every year, you will have an MRI of the brain to check the status of the disease.

Every year, you will have an ECHO or MUGA scan to check the health of your heart.

Anytime the doctor decides it is needed, you will have scans such as a CT scan of the pelvis, an MRI scan of the abdomen or brain, ECHO or MUGA scan, and/or a bone scan.

After 1 year, if the disease has not gotten worse, you may have less clinic visits and tests.

Length of Participation:

You may continue taking a study drug for as long as the doctor thinks it is in your best interest. You will no longer be able to take a study drug if intolerable side effects occur, or if the disease gets worse after you take your second assigned study drug.

End-of-Treatment Visit:

When you are finished taking the study drug(s):

  • You will have a physical exam, including measurement of your weight and vital signs.
  • You will be asked about any drugs you may be taking.
  • You will be asked about any side effects you may have had.

Long-Term Follow-Up:

After your End-of-Treatment visit, the study staff will contact you by phone, e-mail, or you will come in for a clinic visit. You will be asked about how you are feeling and any side effects you may have had. Each follow-up will take about 5 minutes. Follow-up will take place every 3 months for the first 2 years, every 6 months for the third year, and 1 time a year after that. The last follow-up will be about 5 years after the last patient is enrolled.

This is an investigational study. Everolimus, bevacizumab, and pazopanib are all FDA approved and commercially available for kidney cancer. The investigational part of this study is to find out which order these drugs should be given in.

Up to 240 patients will be enrolled in this study. All will be enrolled at MD Anderson.

Conditions
Kidney Cancer
Being tested
Pazopanib, Bevacizumab, Everolimus
Keywords
Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma, Clear cell component, RCC, Bevacizumab, Everolimus, Pazopanib, GW786034, Avastin, Anti-VEGF monoclonal antibody, rhuMAb-VEGF, Afinitor, RAD001
Medical subject headings
Kidney Neoplasms, Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PazopanibDrug

    Also called GW786034

    800 mg by mouth once daily for 28 days. A cycle consists of 4 weeks.

  • BevacizumabDrug

    Also called Avastin, Anti-VEGF monoclonal antibody, rhuMAb-VEGF

    10 mg/kg by vein every two weeks. A cycle consists of 4 weeks.

  • EverolimusDrug

    Also called Afinitor, RAD001

    10 mg by mouth once daily. A cycle consists of 4 weeks.

Study groups in NCT01217931
Study groupRoleWhat they receive
Group 1ExperimentalPazopanib + possible Bevacizumab
Receives: Drug: Pazopanib; Drug: Bevacizumab
Group 2ExperimentalPazopanib + possible Everolimus
Receives: Drug: Pazopanib; Drug: Everolimus
Group 3ExperimentalEverolimus + possible Bevacizumab
Receives: Drug: Bevacizumab; Drug: Everolimus
Group 4ExperimentalEverolimus + possible Pazopanib
Receives: Drug: Pazopanib; Drug: Everolimus
Group 5ExperimentalBevacizumab + possible Pazopanib
Receives: Drug: Bevacizumab
Group 6ExperimentalBevacizumab + possible Everolimus
Receives: Drug: Bevacizumab; Drug: Everolimus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to Overall Treatment Failure

    Measured from date of randomization to date of second disease progression, 'drop-out' from protocol treatment for any reason or death, associated with each of the six two-agent sequential therapies given in parallel.

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2010 (estimated)
  2. Study start19 Jan 2011
  3. Primary completion31 Jan 2028 (estimated)
  4. Study completion31 Jan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01217931
Sponsor's protocol ID
2010-0085
Other IDs
NCI-2011-00256
Status last verified
Jul 2026
First submitted
7 Oct 2010
Last updated
16 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pazopanib, Bevacizumab and Everolimus in people with Kidney Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Overall Treatment Failure (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01217931.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.

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