Dosing and Effectiveness Study of Sorafenib and RAD001 in the Treatment of Patients With Advanced Kidney Cancer

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Sorafenib

RAD001

About this trial

This is an interventional treatment trial for Kidney Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Clinically documented metastatic or unresectable locally recurrent clear cell renal carcinoma
Previous removal of kidney except if the size of the tumor was less than 5 cm or there was extensive liver or bone metastasis
May have had no prior chemotherapy or up to 1 prior treatment regimen with immunotherapy or chemotherapy
Performance status of 0-1
Measurable disease
Adequate liver, renal, and bone marrow function
Must be able to give written informed consent
Women able to become pregnant must have a negative pregnancy test
Must be 18 or over
Must be able to swallow pills

Exclusion Criteria:

Prior treatment with sorafenib or m-TOR inhibitors
History of acute MI within the last 6 months
Active brain metastasis or patients with meningeal metastases
Prior treatment for another cancer in the last 5 years
Prior bleeding problems; coughing up or vomiting blood
Non-healing wounds, ulcer, or long bone fracture
Chronic use of systemic steroids or immunosuppressive agents
Uncontrolled hypertension

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RAD001 and Sorafenib

Arm Description

RAD001 and Sorafenib

Outcomes

Primary Outcome Measures

Overall Response Rate (ORR) of Patients Treated at MTD/Phase II Dose Level

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response Rate (ORR) = Percentage of Patients Who Experience an Objective Response (CR+ PR) to Treatment. In oncology, this outcome measure is reported for all patients treated at the same dose level and is not separated into Phase I and Phase II. The phase I and phase II results are not separated out as the timing of their enrollment (early in phase 1 or later phase II) is not relevant to the outcome measure.

Secondary Outcome Measures

Progression-Free Survival for Patients Treated at MTD/Phase II Dose Level

Progression is Defined Using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% Increase in the Sum of the Longest Diameter of Target Lesions, or a Measurable Increase in a Non-target Lesion, or the Appearance of New Lesions. Progression-free survival was defined as the interval from the date of study entry until the date of tumor progression or death for the patients treated at the MTD/Phase II dose level. This outcome measure is reported for all patients treated at the same dose level and is not separated into Phase I and Phase II. The phase I and phase II results are not separated out as the timing of their enrollment (early in phase 1 or later phase II) is not relevant to the outcome measure.

Full Information

NCT ID

NCT00392821

First Posted

October 25, 2006

Last Updated

May 10, 2022

Sponsor

SCRI Development Innovations, LLC

Collaborators

Novartis, Bayer

1. Study Identification

Unique Protocol Identification Number

NCT00392821

Brief Title

Dosing and Effectiveness Study of Sorafenib and RAD001 in the Treatment of Patients With Advanced Kidney Cancer

Official Title

Phase I/II Trial of Sorafenib (Nexavar) and RAD001 (Everolimus)in the Treatment of Patients With Advanced Clear Cell Renal Cell Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

December 2006 (undefined)

Primary Completion Date

October 2013 (Actual)

Study Completion Date

October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SCRI Development Innovations, LLC

Collaborators

Novartis, Bayer

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

This study is being done in 2 parts. The first part is to determine the dose of RAD001 that should be used in combination with sorafenib. The second part is using the above determined dose of RAD001 in combination with sorafenib to see how effective these 2 drugs are against advanced kidney cancer. Participants will be asked to keep a pill diary.

Detailed Description

The drugs used in this trial are called targeted drugs as they target specific activities that are carried out by cancer cells that make them grow and spread. Sorafenib is an approved drug for the treatment of advanced kidney cancer. RAD001 is an experimental drug that has been used in other research studies with other types of cancer. In this trial, the use of RAD001 and sorafenib together for the treatment of kidney cancer is experimental. In the Phase I portion of this study 13-16 patients will be treated with the same dose of sorafenib and different doses of RAD001. The purpose is to see what is a safe dose of RAD001 when combined with sorafenib in the treatment of kidney cancer. Once this dose of RAD001 is determined, about 65 more patients will be treated to see how effective this combination of drugs is against this kidney cancer. Both of these drugs are taken by mouth. Sorafenib will be taken twice a day. RAD001 is taken by mouth weekly. Patients will be able to continue treatment as long as their disease does not worsen or side effects become intolerable.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

78 (Actual)

8. Arms, Groups, and Interventions

Arm Title

RAD001 and Sorafenib

Arm Type

Experimental

Arm Description

RAD001 and Sorafenib

Intervention Type

Drug

Intervention Name(s)

Sorafenib

Other Intervention Name(s)

Nexavar

Intervention Description

Sorafenib

Intervention Type

Drug

Intervention Name(s)

RAD001

Other Intervention Name(s)

Everolimus, Zortress, Certican

Intervention Description

RAD001

Primary Outcome Measure Information:

Title

Overall Response Rate (ORR) of Patients Treated at MTD/Phase II Dose Level

Description

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response Rate (ORR) = Percentage of Patients Who Experience an Objective Response (CR+ PR) to Treatment. In oncology, this outcome measure is reported for all patients treated at the same dose level and is not separated into Phase I and Phase II. The phase I and phase II results are not separated out as the timing of their enrollment (early in phase 1 or later phase II) is not relevant to the outcome measure.

Time Frame

18 months

Secondary Outcome Measure Information:

Title

Progression-Free Survival for Patients Treated at MTD/Phase II Dose Level

Description

Progression is Defined Using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% Increase in the Sum of the Longest Diameter of Target Lesions, or a Measurable Increase in a Non-target Lesion, or the Appearance of New Lesions. Progression-free survival was defined as the interval from the date of study entry until the date of tumor progression or death for the patients treated at the MTD/Phase II dose level. This outcome measure is reported for all patients treated at the same dose level and is not separated into Phase I and Phase II. The phase I and phase II results are not separated out as the timing of their enrollment (early in phase 1 or later phase II) is not relevant to the outcome measure.

Time Frame

18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Clinically documented metastatic or unresectable locally recurrent clear cell renal carcinoma Previous removal of kidney except if the size of the tumor was less than 5 cm or there was extensive liver or bone metastasis May have had no prior chemotherapy or up to 1 prior treatment regimen with immunotherapy or chemotherapy Performance status of 0-1 Measurable disease Adequate liver, renal, and bone marrow function Must be able to give written informed consent Women able to become pregnant must have a negative pregnancy test Must be 18 or over Must be able to swallow pills Exclusion Criteria: Prior treatment with sorafenib or m-TOR inhibitors History of acute MI within the last 6 months Active brain metastasis or patients with meningeal metastases Prior treatment for another cancer in the last 5 years Prior bleeding problems; coughing up or vomiting blood Non-healing wounds, ulcer, or long bone fracture Chronic use of systemic steroids or immunosuppressive agents Uncontrolled hypertension Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John D Hainsworth, MD

Organizational Affiliation

SCRI Development Innovations, LLC

Official's Role

Principal Investigator

Facility Information:

Facility Name

Florida Hospital Cancer Institute

City

Orlando

State/Province

Florida

ZIP/Postal Code

32804

Country

United States

Facility Name

Northeast Georgia Medical Center

City

Gainesville

State/Province

Georgia

ZIP/Postal Code

30501

Country

United States

Facility Name

Wellstar Cancer Research

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30060

Country

United States

Facility Name

Baptist Hospital East

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40207

Country

United States

Facility Name

Norton Cancer Institute

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40207

Country

United States

Facility Name

Research Medical Center

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64132

Country

United States

Facility Name

Hematology Oncology Associates of Northern NJ

City

Morristown

State/Province

New Jersey

ZIP/Postal Code

07960

Country

United States

Facility Name

Oncology Hematology Care

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45242

Country

United States

Facility Name

South Carolina Oncology Associates, PA

City

Columbia

State/Province

South Carolina

ZIP/Postal Code

29210

Country

United States

Facility Name

Spartanburg Regional Medical Center

City

Spartanburg

State/Province

South Carolina

ZIP/Postal Code

29303

Country

United States

Facility Name

Tennessee Oncology, PLLC

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37023

Country

United States

Kidney Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial