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Renal Cell CarcinomaPhase 1Rad/SutentNCT00788060

A Phase Ib Study of Rad001 and Sutent to Treat Renal Cell Carcinoma

A Phase 1 study testing Everolimus (RAD001) and Sunitinib (Sutent) in people with Renal Cell Carcinoma, run by Daniel George, MD at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a single center, Phase Ib study of Sunitinib and RAD001 in patients with advanced RCC. The study design is a phase I interpatient dose-escalation with a dose expansion at the maximum tolerated dose (MTD) in patients with metastatic RCC . Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Cell Carcinoma
What is being tested?
Everolimus (RAD001) and Sunitinib (Sutent)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteUnited States
Study dates
Oct 2008to Dec 2012
Phase
Phase 1
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients will be eligible for inclusion in this study only if all of the following criteria apply:
  • Patients must have histologically confirmed diagnosis of RCC.
  • Patients must have undergone a nephrectomy
  • Clinical or radiographic evidence of metastatic disease.
  • A minimum of 4 weeks from full field radiation therapy, surgery, chemotherapy or other investigational agent. Treatment may begin one week following limited field radiation therapy.
  • Subjects who have received prior limited field radiotherapy, biologic/immunotherapy or surgery must have a documented recovery period > 2 weeks
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  • Patients must have normal organ and marrow function as defined below:
  • hemoglobin > 9.0g/dL absolute neutrophil count > 1,500/μl platelets > 100,000/μl total bilirubin < 1.5 X upper limit of normal (ULN) AST(SGOT)/ALT(SGPT) < 2.5 X ULN creatinine < 1.5 X ULN (or 24 hour measured creatinine clearance > 40 mL/min) total fasting cholesterol < 350 total triglycerides < 300
  • Age > 18 years.
  • ECOG score of 0-2 (See Appendix 11.1).
  • For patients with diabetes a Hgb A1C of ≤ 8
  • Subject agrees to use a medically acceptable form of birth control during and for at least 3 months after completion of the study treatment, if he/she is sexually active
  • Women of childbearing potential must have a negative serum pregnancy test within 3 days prior to treatment
  • Ability to swallow and retain oral medication.
  • Ability to understand and the willingness to sign a written informed consent document.
  • Written informed consent obtained according to local guidelines

Who cannot join

  • A patient will not be eligible for inclusion in this study if any of the following criteria apply:
  • History of solid organ or stem cell transplantation. Also, no current use of chronic immunosuppressive therapy is allowed.
  • Patients with active brain metastases (or history of brain metastases) should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  • History of HIV, hepatitis B, or hepatitis C infection.
  • Patients who have received investigational, biologic, hormonal (other than ADT), immunotherapy, or chemotherapy less than 4 weeks prior to entry on this study or have not recovered from the toxic effects of such therapy.
  • Patients who have experienced severe trauma or undergone major surgery within 4 weeks prior to entry on this study or have not recovered to grade 1 or less may not participate.
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  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (requiring antifungal, antibiotic or antiviral therapy), symptomatic congestive heart failure (NYHC II or greater), unstable angina pectoris, cardiac arrhythmia (uncontrolled SVT or any VT), uncontrolled diabetes or psychiatric illness/social situations that would limit compliance with study requirements.
  • Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection).
  • Patients who have received prior treatment with an mTOR inhibitor.
  • Patients who have received prior treatment with Sunitinib are not eligible to participate in this study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Duke University Medical Center

    Durham, North Carolina, 27705

Other trials in United States

About this study

Official title: A Single Arm, Phase Ib Study of RAD001 and Sunitinib in Patients With Advanced Renal Cell Carcinoma

This is a single center, Phase Ib study of Sunitinib and RAD001 in patients with advanced RCC. The study design is a phase I interpatient dose-escalation with a dose expansion at the maximum tolerated dose (MTD) in patients with metastatic RCC . In the dose escalation portion, patients will be treated with sunitinib, given in an intermittent schedule (2 weeks of daily dosing followed by one week off drug. RAD001 will be given daily. Escalation of both drugs will occur as tolerated. Treatment will be arbitrarily divided into 3-week cycles, with dose limiting toxicity (DLT) determined by Cycle 2 Day 0.

Read the detailed description

Escalation of both drugs will occur as tolerated. Treatment will be arbitrarily divided into 3-week cycles, with dose limiting toxicity (DLT) determined by Cycle 2 Day 0. Dose levels will be evaluated one at a time beginning with 3 patients. If 1/3 patients demonstrate DLT (as defined in section Complete), then enrollment will proceed to the next dose level. 1/3 patients develops a DLT, then 3 more patients will be accrued to this dose level. If 0-1/6 patients demonstrate DLT, then enrollment will proceed to the next dose level. However, if 2 or more patients out of 6 demonstrate DLT at a dose level, then enrollment will proceed at the next lowest dose level. The highest dose level not resulting in greater than 1/6 DLT will be considered the MTD. Dose expansion will then proceed at this dose level.

Once the maximum tolerated dose has been established for this regimen a dose expansion of 20 patients with metastatic RCC will be undertaken. Up to 10 patients with a positive FDG- PET scan at baseline (defined by 1 or more target lesions demonstrating an SUV > 5.0) will begin treatment per Figure 2B. Patients 1-10 will begin Sunitinib on Day 0 and begin RAD001 on Day 14 after repeat FDG-PET scan. Patients 11-20, will have a 2 week lead-in period of RAD001 and will begin Sunitinib 2 weeks later on Day 0. After repeat FDG-PET scan. Both groups of patients will repeat PET scan at Day 14 of cycle 2. Patients with negative FDG PET scans (SUV < 5.0 in all lesions) will not undergo repeat scanning. Patients will undergo evaluations for tumor response every 12 weeks with appropriate measurement studies (CT, MRI, bone scan). In the setting of a mixed response (progressive disease in 1 or more lesions but continued regression or stable disease below baseline in other lesions) patients may continue on study if it is determined by the PI, treating physician and patient that there is ongoing clinical benefit to the patient.

Being tested
Everolimus (RAD001), Sunitinib (Sutent)
Keywords
Renal Cell Carcinoma, Rad001, Sutent
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.

  • Everolimus (RAD001)Drug

    Also called RAD001

    5mg per day, continuously

  • Sunitinib (Sutent)Drug

    Also called Sutent

    37.5 mg per day, 14 days on, 7 day break

Study groups in NCT00788060
Study groupRoleWhat they receive
RAD001ExperimentalNot described
Receives: Drug: Everolimus (RAD001); Drug: Sunitinib (Sutent)

What is being measured

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

  1. To determine the maximum tolerated dose (MTD)/recommended Phase 2 regimen of 2+1 dosing with Sunitinib and daily RAD001 in patients with advanced renal cell carcinoma.

    Measured: 1 year

  2. To determine the safety and tolerability of 2+1 dosing of Sunitinib and daily RAD001 in patients with advanced RCC

    Measured: 1 year

  3. To more fully evaluate the safety and tolerability of 2+1 dosing of Sunitinib and daily RAD001 at the MTD/recommended Phase 2 dose in patients with advanced RCC

    Measured: 1 year

Secondary outcomes (5)

  1. Describe the non-dose limiting toxicities associated with combination therapy using 2+1 dosing Sunitinib and daily RAD001.

    Measured: 1 year

  2. Describe the pharmacokinetics of Sunitinib and RAD001 and evaluate any association with disease response

    Measured: 1 year

  3. To estimate objective response rate (partial or complete) seen in patients with advanced RCC in a dose expansion cohort treated at the MTD or recommended Phase 2 dose regimen

    Measured: 1 year

  4. To estimate the overall survival of RCC patients treated with Sunitinib and RAD001

    Measured: 1 year

  5. To estimate the time to disease progression of RCC patients treated with Sunitinib and RAD001

    Measured: 1 year

Timeline

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

  1. First posted10 Nov 2008 (estimated)
  2. Study startOct 2008
  3. Primary completionDec 2012
  4. Study completionDec 2012

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00788060
Sponsor's protocol ID
Pro00000548
Acronym
Rad/Sutent
Status last verified
Feb 2015
First submitted
6 Nov 2008
Last updated
16 Feb 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Everolimus (RAD001) and Sunitinib (Sutent) in people with Renal Cell Carcinoma, run by Daniel George, MD 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 16 inclusion and 10 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: finished, as of the sponsor's last update on 16 Feb 2015. 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 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.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

To determine the maximum tolerated dose (MTD)/recommended Phase 2 regimen of 2+1 dosing with Sunitinib and daily RAD001 in patients with advanced renal cell carcinoma. (time frame: 1 year). 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 NCT00788060.

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 Feb 2015.

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