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

NCT00788060

Last updated date
Study Location
Duke University Medical Center
Durham, North Carolina, 27705, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Cell Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

- 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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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.


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Phase Ib Study of Rad001 and Sutent to Treat Renal Cell Carcinoma
Official Title  ICMJE A Single Arm, Phase Ib Study of RAD001 and Sunitinib in Patients With Advanced Renal Cell Carcinoma
Brief 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 . 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Renal Cell Carcinoma
Intervention  ICMJE
  • Drug: Everolimus (RAD001)
    5mg per day, continuously
    Other Name: RAD001
  • Drug: Sunitinib (Sutent)
    37.5 mg per day, 14 days on, 7 day break
    Other Name: Sutent
Study Arms  ICMJE Experimental: RAD001
Interventions:
  • Drug: Everolimus (RAD001)
  • Drug: Sunitinib (Sutent)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 11, 2014)
5
Original Estimated Enrollment  ICMJE
 (submitted: November 7, 2008)
30
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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
  • Patients must have normal organ and marrow function as defined below:

hemoglobin > 9.0g/dL absolute neutrophil count > 1,500/?l platelets > 100,000/?l 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

Exclusion Criteria:

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.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00788060
Other Study ID Numbers  ICMJE Pro00000548
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Daniel George, MD, Duke University
Study Sponsor  ICMJE Daniel George, MD
Collaborators  ICMJE
  • Novartis
  • Pfizer
Investigators  ICMJE
Principal Investigator:Daniel J. George, M.D.Duke University
PRS Account Duke University
Verification Date February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP