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Renal Cell CarcinomaPhase 1/2NCT02919371

Combined Alternating Sunitinib and Bevacizumab (Avastin®) in Advanced Renal Cell Carcinoma (CASA)

A Phase 1/2 study testing Sunitinib and Bevacizumab in people with Renal Cell Carcinoma, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Combined sunitinib and bevacizumab in advanced renal cell carcinoma. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Renal Cell Carcinoma
What is being tested?
Sunitinib and Bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
77 participants
Where
1 siteSaudi Arabia
Study dates
Dec 2014to Dec 2021
Phase
Phase 1/2
Are there results?
None posted in the registry

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 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed renal cell carcinoma with clear cell histology ( mixed histology with clear cell component is accepted)
  • Patient should have either locally advanced or metastatic disease
  • No prior anti-cancer therapy
  • Age ≥ 18 years
  • Life expectancy of 3 months or more
  • Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1
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  • Performance status 0-2 by ECOG scale
  • Patients with controlled brain metastasis are accepted
  • Adequate renal function: serum creatinine ≤ 2 times the institutional upper limit of normal
  • Adequate hepatic function: total bilirubin within normal institutional limits, serum AST and ALT levels ≤2 times the institutional upper limit of normal or ≤ 5 times the institutional upper limit of normal of elevated because of liver involvement
  • Coagulation (PT ≤ 1.5 times the institutional upper limit of normal)
  • Adequate hematological values: leukocyte count ≥3.0 x 109/L, an absolute neutrophil count ≥1.5 x 109/L, a platelet count ≥100 x 109/L and hemoglobin ≥ 9.0 g/dL
  • Urine dipstick for proteinuria <1+, patients discovered to have ≥ 1+ on dipstick urinanalysis at baseline should have urine protein/urine creatinine ratio ≤1
  • Singed written informed consent before enrolment
  • Patient should have unresectable disease ( for both the primary tumor and the metastasis)

Who cannot join

  • Inability to comply with the protocol therapy
  • Uncontrolled hypertension defined as BP more than 160 systolic and or more than 100 diastolic despite adequate treatment at the time of treatment initiation.
  • Severe cardiovascular disease (congestive heart failure NYHA III or IV, unstable angina pectoris, myocardial infarction, significant arrhythmias or Transient ischemic attack (TIA) or cerebrovascular accident (CVA) in the last 6 months
  • Major bleeding disorder, significant traumatic injury or recent major surgery within 28 days of starting therapy. Or minor surgery (FNA/Core biopsy) within 7 days of starting therapy
  • History of abdominal abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months
  • Pre-existing thyroid abnormality
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  • Concurrent proarrhythmic medications including terfenadine, quinidine, procainamide, disopyramide, sotalol, bepridil, haloperidol, risperidone, indapamide and flecainide
  • Recent significant hemoptysis (1/2 tea spoon red blood within last month)
  • Concurrent medication that either CYP 450 3A4 inducers or inhibitors
  • Concurrent use of proarrhythmic medications including terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide and flecainide
  • Pregnancy or breast feeding, or patient refusal to use appropriate contraception for female patients in childbirth age
  • Previous malignancy within 5 years, except adequately treated non melanomatous skin cancer or in situ cervical cancer
  • Psychiatric or mental disorder, precluding understanding of the information of the trial related topics and giving valid informed consent
  • Any psychological, familial, geographic or social circumstances which could impair the patient ability to participate in the trial and comply with follow up.
  • Any circumstance which might impair the patient's ability to comply with an out-patient regimen
  • Active uncontrolled infection
  • Serious underlying medical condition (in the judgment of the investigator) which could impair the ability of the patient to participate in the trial
  • Treatment with other experimental drugs within 30 days of entry into the trial
  • Treatment with other anti-cancer therapy
  • Legal incapacity
  • Significant proteinuria (urine protein: creatinine ratio > 1.0)

Trial locations and contacts

1 site in 1 country.

Shouki Bazarbashi, MD contact

00966 11 442 3935

bazarbashi@kfshrc.edu.sa

Fazal Hussain, MD contact

966-11-4423949

fhussain@kfshrc.edu.sa

Saudi Arabia1 site, 1 recruiting

  • Oncology Centre, King Faisal Specialist Hospital and Research Centre

    Riyadh, 11211

    Shouki Bazarbashi, MD, 00966 11 442 3935, bazarbashi@kfshrc.edu.sa

    Fazal Hussain, MD, 966-11-4423949, fhussain@kfshrc.edu.sa

    Recruiting

Other trials in Saudi Arabia

About this study

Official title: Phase I/II Combined Alternating Sunitinib and Bevacizumab (Avastin®) in Advanced Renal Cell Carcinoma (CASA)

Combined sunitinib and bevacizumab in advanced renal cell carcinoma.

Read the detailed description

This is a phase I/II trial of combined sunitinib and bevacizumab in advanced renal cell carcinoma ( CASBA) where Bevacizumab will be used only on day 29 of each 6 weeks sunitinib cycle.

Being tested
Sunitinib, Bevacizumab
Medical subject headings
Carcinoma, Renal Cell

What participants receive

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

  • SunitinibDrug

    Also called Sutent

    Oral therapy ( Anti-vascular endothelial growth factor Tyrosin Kinase Inhibitor): given as 50 mg daily from day 1 to day 28- cycle repeated every 42 days

  • BevacizumabDrug

    Also called Avastin

    Monoclonal antibody against vascular endothelial growth factor: given intravenously on day 29 of each sunitinib cycle

Study groups in NCT02919371
Study groupRoleWhat they receive
Sunitinib and Bevacizumab ArmExperimentalPhase I/II Combined Alternating Sunitinib and Bevacizumab (Avastin®) in Advanced Renal Cell carcinoma (CASA)Combined Alternating Sunitinib and Bevacizumab
Receives: Drug: Sunitinib; Drug: Bevacizumab

What is being measured

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

  1. Bevacizumab maximum tolerated dose, in combination with sunitinib

    This is the phase I part of the study. patient will enroll on Bevacizumab dose of 5 mg/kg body weight. If no dose limiting toxicity in 1st 6 patients, the dose will be escalated to 10 mg/kg in the remainder of the patients

    Measured: 12 weeks from enrolling patient # 6

  2. Assess response rate to the combination of sunitinib and bevacizumab

    response rate is the combination of partial response and complete response

    Measured: Through study completion, an average of 6 months

  3. Assess the progression free survival on the combination of sunitinib and bevacizumab

    Progression free survival will be calculated from time of starting therapy till progression or death whichever comes first

    Measured: up to 5 years

Secondary outcomes (2)

  1. Overall survival of patients in this regimen

    Overall survival will be calculated from date of start on therapy till death

    Measured: Participants will be followed for the duration of hospital stay, up to 5 years

  2. Number of participants with treatment related-adverse effects as assessed by CTCAE v 4.03

    toxicity will be graded according to the NCI-CTC version 4.03

    Measured: up to 5 years

Timeline

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

  1. First posted29 Sep 2016 (estimated)
  2. Study startDec 2014
  3. Primary completionDec 2020 (estimated)
  4. Study completionDec 2021 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
77 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02919371
Sponsor's protocol ID
2141-102
Status last verified
Aug 2018
First submitted
24 Mar 2015
Last updated
10 Aug 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No: No- unless the data are so encouraging then this can be done

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Sunitinib and Bevacizumab in people with Renal Cell Carcinoma, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.

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 15 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 10 Aug 2018. 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 Saudi Arabia. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Results are not available in the source record.

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

Contact Shouki Bazarbashi, MD (00966 11 442 3935, bazarbashi@kfshrc.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bevacizumab maximum tolerated dose, in combination with sunitinib (time frame: 12 weeks from enrolling patient # 6). The study lists 3 primary outcomes in all. 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 NCT02919371.

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 10 Aug 2018.

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