Renal Cell CarcinomaPhase 1NCT00422344
A Study of RAD001 and Sunitinib in Metastatic Renal Cell Carcinoma
A Phase 1 study testing RAD001, Sunitinib in people with Renal Cell Carcinoma and Kidney Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to test the safety of RAD-001 and Sunitinib given in combination for renal cell cancer. We also want to find out what effects (good and bad) the combination of RAD-001 and Sunitinib have on you and your tumor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma, Kidney Cancer
- What is being tested?
- RAD001, Sunitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Feb 2010
- 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
- Any histologically confirmed renal cell carcinoma with metastases. Patients with unresected primary tumors may be enrolled as long as evidence of metastatic disease is also present.
- No prior sunitinib or m-TOR inhibitor. The washout period must be at least 4 weeks for any prior therapy.
- Male or female, 18 years of age or older.
- ECOG performance status 0 or 1.
- Resolution of all acute toxic effects of prior chemotherapy, radiotherapy, or surgical procedure to NCI CTCAE grade less than or equal to 1.
- Adequate organ function as defined by the following criteria:
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- Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) less than or equal to 2.5 x upper limit of normal (ULN) or less than 5 x ULN in the presence of liver metastases.
- Total serum bilirubin less than or equal to 1.5 mg/dL
- Total leukocyte count greater to or equal to 3000 cells/ul
- Absolute neutrophil count (ANC) greater than or equal to 1500/µL
- Platelets greater than or equal to 100,000/µL
- Hemoglobin greater than or equal to 9.0 g/dL
- Serum calcium less than or equal to 12.0 mg/dL
- Serum creatinine less than or equal to 2.0 x ULN
- PT less than or equal to 1.5 ULN
- Negative serum or urine pregnancy test in women of child-bearing age
- Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment.
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
Who cannot join
- Major surgery, open biopsy, traumatic injury, radiation or systemic therapy within 4 weeks of starting the study treatment. Anticipation of major surgical procedure during the study. Prior palliative radiotherapy to metastatic lesion(s)is permitted, provided there is at least one measurable lesion that has not been irradiated.
- More than 3 prior systemic therapies for metastatic RCC.
- Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to Day 0.
- No other approved or investigational anticancer treatment will be permitted during the study period, including chemotherapy, biological response modifiers, hormone therapy, or immunotherapy, with the exception of palliative radiation therapy. No other investigational drug may be used during treatment on this protocol, and concurrent participation in another clinical trial is not allowed.
- NCI CTCAE grade 3 hemorrhage within the past 1 month.
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0.
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- Chronic treatment with systemic steroids or other immunosuppressive agent
- Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases
- Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of Sunitinib or RAD001 (e.g. malabsorptive disorder, ulcerative disease, uncontrolled nausea, vomiting, diarrhea, or small bowel resection)
- Patients with an active bleeding diathesis or on oral anti-vitamin K medication (except low dose warfarin)
- Current spinal cord compression, or carcinomatous meningitis.
- Any of the following within the 12 months prior to study drug administration:
- severe/unstable angina,
- MI,
- CABG,
- symptomatic congestive heart failure,
- cerebrovascular accident or transient ischemic attack or peripheral vascular disease.
- Ongoing cardiac dysrhythmias of NCI CTCAE grade greater or equal to 2, atrial fibrillation of any grade, or prolongation of the QTc interval to >450 msec for males and >470 msec for females.
- Blood pressure > 150/100mmHg
- Evidence of bleeding diathesis or coagulopathy
- Serious, non-healing wound, ulcer or bone fracture
- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
- Current treatment on another therapeutic clinical trial.
- Pregnancy or breastfeeding. Female patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy.
- Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.
- Receipt of any investigational agent within 4 weeks prior to study entry.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center 1275 York Avenue
New York, New York, 10021
About this study
Official title: A Phase I Study of RAD001 and Sunitinib in Metastatic Renal Cell Carcinoma Patients
The purpose of this study is to test the safety of RAD-001 and Sunitinib given in combination for renal cell cancer. We also want to find out what effects (good and bad) the combination of RAD-001 and Sunitinib have on you and your tumor.
RAD001 is a pill that works by shutting down some of the pathways in the cell that make tumors grow. Sunitinib is a pill that works by shutting off the signal in the cancer cells that tell the cells to grow blood vessels. Without this signal, the blood vessels to the tumors shrink down.
Read the detailed description
To assess the maximum tolerated doses and overall safety and tolerability of Sunitinib administered in combination with RAD001 for the treatment of patients with metastatic renal cell carcinoma.
To assess antitumor activity of the combination of Sunitinib and RAD001.
This study is designed to confirm that the 2 agents can be administered safely in combination. Patients will begin treatment with Sunitinib and RAD001 on Day 1. RAD001 will be administered orally on a weekly schedule. Sunitinib will be given orally on a 4 weeks on, 2 weeks off schedule. DLT determination will be based on toxicities observed in Cycle 1 - a cycle is defined by Sunitinib dosing ( 6 weeks). Once the MTD for the combination has been identified, a total of 10 patients will be enrolled at the highest dose level that allows for administration of multiple cycles and provides potentially therapeutic drug levels of both drugs to further assess safety and tolerability and to obtain a preliminary assessment of efficacy. Patients will be treated with RAD001 and Sunitinib until there is disease progression, significant toxicity or withdrawal of patient consent. Patients judged to derive benefit from treatment would be offered participation in a continuation protocol at the conclusion of this study.
- Conditions
- Renal Cell Carcinoma, Kidney Cancer
- Being tested
- RAD001, Sunitinib
- Keywords
- RAD001, Sunitinib, renal, kidney
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAD001, SunitinibDrug
Patients will start treatment with Sunitinib and RAD001 on Cycle 1, Day 1. Sunitinib will be given orally daily for 4 weeks followed by a 2 week rest period. RAD001 will be given orally daily or weekly in subsequent cohorts with the first treatment on day 1. DLT determination will be based on toxicities observed in Cycles 1 - a cycle being defined by Sunitinib dosing. Once the MTD for the combination has been identified, a total of 10 patients will be enrolled into the study at the highest dose level that allows for administration of multiple cycles and provides potentially therapeutic drug levels of both drugs
| Study group | Role | What they receive |
|---|---|---|
| RAD001 AND SUNITINIB | Experimental | RAD001 AND SUNITINIB IN METASTATIC RENAL CELL CARCINOMA PATIENTS Receives: Drug: RAD001, Sunitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the maximum tolerated doses and overall safety and tolerability of Sunitinib administered in combination with RAD001 for the treatment of patients with metastatic renal cell carcinoma.
Measured: toxicities observed in Cycle 1 - a cycle is defined by Sunitinib dosing ( 6 weeks)
Secondary outcomes (1)
To assess antitumor activity of the combination of Sunitinib and RAD001.
Measured: conclusion of this study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2007 (estimated)
- Study startOct 2006
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Investigators
- Glenn Kroog, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00422344
- Sponsor's protocol ID
- 06-105
- Status last verified
- Feb 2010
- First submitted
- 12 Jan 2007
- Last updated
- 26 Feb 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of RAD001 and Sunitinib in Metastatic Renal Cell Carcinoma Patients
- ClinicalTrials.gov ID
- NCT00422344
- Acronym / sponsor ID
- 06-105
- Conditions
- Renal Cell Carcinoma, Kidney Cancer
- Keywords
- RAD001, Sunitinib, renal, kidney
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Oct 2006
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 15 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the safety of RAD-001 and Sunitinib given in combination for renal cell cancer. We also want to find out what effects (good and bad) the combination of RAD-001 and Sunitinib have on you and your tumor.
RAD001 is a pill that works by shutting down some of the pathways in the cell that make tumors grow. Sunitinib is a pill that works by shutting off the signal in the cancer cells that tell the cells to grow blood vessels. Without this signal, the blood vessels to the tumors shrink down.
Detailed description
To assess the maximum tolerated doses and overall safety and tolerability of Sunitinib administered in combination with RAD001 for the treatment of patients with metastatic renal cell carcinoma.
To assess antitumor activity of the combination of Sunitinib and RAD001.
This study is designed to confirm that the 2 agents can be administered safely in combination. Patients will begin treatment with Sunitinib and RAD001 on Day 1. RAD001 will be administered orally on a weekly schedule. Sunitinib will be given orally on a 4 weeks on, 2 weeks off schedule. DLT determination will be based on toxicities observed in Cycle 1 - a cycle is defined by Sunitinib dosing ( 6 weeks). Once the MTD for the combination has been identified, a total of 10 patients will be enrolled at the highest dose level that allows for administration of multiple cycles and provides potentially therapeutic drug levels of both drugs to further assess safety and tolerability and to obtain a preliminary assessment of efficacy. Patients will be treated with RAD001 and Sunitinib until there is disease progression, significant toxicity or withdrawal of patient consent. Patients judged to derive benefit from treatment would be offered participation in a continuation protocol at the conclusion of this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RAD001 AND SUNITINIB | Experimental | Drug: RAD001, SunitinibRAD001 AND SUNITINIB IN METASTATIC RENAL CELL CARCINOMA PATIENTS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Any histologically confirmed renal cell carcinoma with metastases. Patients with unresected primary tumors may be enrolled as long as evidence of metastatic disease is also present.
- No prior sunitinib or m-TOR inhibitor. The washout period must be at least 4 weeks for any prior therapy.
- Male or female, 18 years of age or older.
- ECOG performance status 0 or 1.
- Resolution of all acute toxic effects of prior chemotherapy, radiotherapy, or surgical procedure to NCI CTCAE grade less than or equal to 1.
Key exclusion criteria (27 listed)
- Major surgery, open biopsy, traumatic injury, radiation or systemic therapy within 4 weeks of starting the study treatment. Anticipation of major surgical procedure during the study. Prior palliative radiotherapy to metastatic lesion(s)is permitted, provided there is at least one measurable lesion that has not been irradiated.
- More than 3 prior systemic therapies for metastatic RCC.
- Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to Day 0.
- No other approved or investigational anticancer treatment will be permitted during the study period, including chemotherapy, biological response modifiers, hormone therapy, or immunotherapy, with the exception of palliative radiation therapy. No other investigational drug may be used during treatment on this protocol, and concurrent participation in another clinical trial is not allowed.
- NCI CTCAE grade 3 hemorrhage within the past 1 month.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RAD001, SunitinibPatients will start treatment with Sunitinib and RAD001 on Cycle 1, Day 1. Sunitinib will be given orally daily for 4 weeks followed by a 2 week rest period. RAD001 will be given orally daily or weekly in subsequent cohorts with the first treatment on day 1. DLT determination will be based on toxicities observed in Cycles 1 - a cycle being defined by Sunitinib dosing. Once the MTD for the combination has been identified, a total of 10 patients will be enrolled into the study at the highest dose level that allows for administration of multiple cycles and provides potentially therapeutic drug levels of both drugs | Drug | RAD001 AND SUNITINIB |
Primary outcome
To assess the maximum tolerated doses and overall safety and tolerability of Sunitinib administered in combination with RAD001 for the treatment of patients with metastatic renal cell carcinoma.
Time frame: toxicities observed in Cycle 1 - a cycle is defined by Sunitinib dosing ( 6 weeks)
1 secondary outcome
To assess antitumor activity of the combination of Sunitinib and RAD001.
Time frame: conclusion of this study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2010.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
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RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
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Localized Clear Cell Renal Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glenn Kroog, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RAD001, Sunitinib in people with Renal Cell Carcinoma and Kidney Cancer, run by Memorial Sloan Kettering 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 18 inclusion and 27 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 26 Feb 2010. 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 assess the maximum tolerated doses and overall safety and tolerability of Sunitinib administered in combination with RAD001 for the treatment of patients with metastatic renal cell carcinoma. (time frame: toxicities observed in Cycle 1 - a cycle is defined by Sunitinib dosing ( 6 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Feb 2010.